Criticalthinking-Order924380….. xRTCexercise1 RCTexercise2 Assignment2exemplar-score90
 

• Type of paperCritical Thinking
• SubjectNursing
• Number of pages3
• Format of citationHarvard
• Number of cited resources5
• Type of serviceWriting

two papers been evaluated on effect on telephone based counselling in Physical activity in women with breast cancer 1. I already critiqued the 2 topics and both concluded in positive impact of TELEPHONE BASED INTERVENTION (this is my intervention which i want to implement in clinical settings for best care of breast cancer patients as it help in reducing recurrence). 2. involvement of CLINICAL GUIDELINES in Telephone counselling in Physical activity. is there is or not?? 3. How it can be involved effectively in patient care. as telephone counselling in Physical activity is not a primary part of treatment, WHY, and HOW can change be introduce?? 3. Do nurses supposed to take this job for counselling?? incentives for them??? or WHAT should be involved for promoting the care?? OR special physical examiner role to be create?? 4. if CHANGE can not be made?? than what?? other nursing or medical strategies in promoting PA through TC? 5. please all data should be referenced well… and NOT be Desсrіptive with no references… 6. attaching a example of better understanding of my ideas… but definitely different way of writing. thank you

Telephone Based Intervention 1

TELEPHONE-BASED INTERVENTION AND IMPLEMENTATION IN CLINICAL SETTING

By

COURSE NAME

TUTOR

SCHOOL AFFILIATIONS

CITY/STATE

DATE

Telephone-Based Intervention and Implementation in Clinical Setting

Introduction

Breast cancer treatment requires diverse approaches- medical, conventional and psychological. The combination of these methods yields better results. Telephone involvement is required by these patients to support, guide and follow up the progress of patients. Telephone-based intervention has positive impacts on breast cancer victims in their physical activities and treatment if implemented well in any clinical environment (McHugh and Barlow, 2010). The support offered through telephone is to help in patient behavior management, help the patient emotionally and socially and also educate the caregivers on how to manage the patient. The healthcare support provided lies in the professional outline of the clinical guidelines. Comment by laila al balushi: These all are definitions, descriptions … I need interventions in PA how to carry it in clinical.
Issues that prevent carting the PA ..
The example was clear how to make it without introduction, or conclusion.
I just need how to implement it in clinical settings

Body

Provision of telephone support by health care givers strictly lies within the clinical guidelines. The intervention should be aimed accelerating the healing process of patients. The support should lie within the set guidelines and should be evidence-based (Guivarch and Hallegatte, 2012). The extent to which these guidelines should be involved depends on a number of things. First, the guidelines should lead to a measurable and achievable telephone support exercise. Secondly, the implementation guidelines of clinical practice should give priority to the evidence-based practice and also take into consideration the workability. The measures taken should consider research findings on how effective will the guidelines be and their effect on their use.

Breast cancer requires complex treatment procedures some of which are scary and risky. A patient needs to be prepared mentally prior to any of the medical procedures. Telephone intervention can be used to educate and encourage the patient. Breast cancer patients need to be stable free from all stress. The patients require preoccupation. In stress management, physical activities are essential. Physical activities also improve the body’s immunity.

In treating Breast cancer patients, the telephone support should be a crucial tool in motivating the patient to do physical activities. The telephone support should encourage the patients to do a variety of physical activities. Considering the difficulty of doing any physical activities by patients, the professional taking the patient through the exercise ought to be committed. The health care professional should then make follow-ups via telephone. This way, the patient will feel encouraged and it will minimize the chances of the patient skipping any physical activity.

Counseling is not the primary treatment for breast cancer, however, it is crucial. Research indicates that breast cancer survival rates have increased due to the telephone counseling. It is recommendable that the exercise is rigorous and friendly so that not to scare the patient.to achieve the goal of providing a rigorous telephone counseling and physical activity all the nurses should be trained on how to counsel.

Implementation of telephone support services will require that the nurses be trained counselors. This way nurses who are not employed as a nurse can be employed as a breast cancer patient counselor. Counseling is effective in the management of breast cancer (Grol, Richard, 2010). There is evidence which shows that 90% of patients who get counseled recover successfully while those who do not get counseled succumb to the disease. The nurses who counsel patients with breast cancer should have a rich set of skills in handling the patients. These set of skills include good listening ability, stress management skills and good communication skills. A nurse who works as a counselor and at the same time as a caregiver should be encouraged and given higher wages as an incentive. Comment by laila al balushi: What do mean by this?? confusing

To promote the care, toll-free numbers should be created for patients to consult anytime they have a need. The patients from the same region should be encouraged to form help groups. The help groups can be counseled as a group and be encouraged to do physical activities as a group. This will make the physical activities fun. These groups should be manned by special physical examiners. The role should be created purposely to serve the breast cancer patients. Comment by laila al balushi: First intervention. Good Comment by laila al balushi: In need only for physical activity.

In the current system, there are gaps in the strategy. To cover for these gaps a new model has to be used. This model involves adopting a telephone-based intervention model which can be translated and it involves more than one function. The model will be automated and inform of an application which reminds the patients the physical activities they have to do. The model will be more effective than the group interventions (Whitlock, et al 2002). The telephone-based intervention application will contain educative and motivation messages in form of pictures and videos. This form of the interface has more effects than the previous one where the patient would only talk to a nurse and follow instructions.in a more concrete way, this will be like the telephone-based intervention counseling application for breast cancer patients. Comment by laila al balushi: Good as it is an intervention.

Conclusion

Breast cancer requires rigorous medical procedures of which the patient alone cannot handle. The health providers and caregivers to these patients must be committed to helping these patients through the healing process. Counseling and helping the patient to do various physical activities will help the patient reduce the stress level and accelerate the healing process (Grim Shaw et al, 2004) Innovative idea on how to help the cancer patients increase their levels of physical activities should be embraced. The designing of a patient-specific program will go a long way in helping the patients. In various researches conducted the telephone-based intervention counseling leads an increase in the physical activity among patients Comment by laila al balushi: No need for conclusion. Please I need ways to implement telephone counselling in PA in clinical settings only.
Thanks

References

McHugh, R. Kathryn, and David H. Barlow. “The dissemination and implementation of evidence-based psychological treatments: a review of current efforts.” American Psychologist65, no. 2 (2010): 73.

Whitlock, E.P., Orleans, C.T., Pender, N. and Allan, J., 2002. Evaluating primary care behavioural counselling interventions: An evidence-based approach 1. American journal of preventive medicine, 22(4), pp.267-284.

. Heron, Kristin E. and Joshua M. Smyth. “Ecological momentary interventions: incorporating mobile technology into psychosocial and health behaviour treatments.” British journal of health psychology 15, no. 1 (2010): 1-39.

Grol, Richard. “Successes and failures in the implementation of evidence-based guidelines for clinical practice.” Medical care 39, no. 8 (2001): II-46.

Grimshaw, J., R. Thomas, G. MacLennan, C. R. R. C. Fraser, C. R. Ramsay, L. E. E. A. Vale, P. Whitty et al. “Effectiveness and efficiency of guideline dissemination and implementation strategies.” (2004).

C L I N I C A L T R I A L

Impact of a telephone-based physical activity intervention
upon exercise behaviors and fitness in cancer survivors
enrolled in a cooperative group setting

Jennifer A. Ligibel • Jeffrey Meyerhardt • John P. Pierce • Julie Najita •

Laura Shockro • Nancy Campbell • Vicky A. Newman • Leslie Barbier •

Eileen Hacker • Marie Wood • James Marshall • Electra Paskett •

Charles Shapiro

Received: 5 October 2011 / Accepted: 10 November 2011 / Published online: 24 November 2011

� Springer Science+Business Media, LLC. 2011

Abstract Observational studies demonstrate an associa-

tion between physical activity and improved outcomes in

breast and colon cancer survivors. To test these observa-

tions with a large, randomized clinical trial, an intervention

that significantly impacts physical activity in these patients

is needed. The Active After Cancer Trial (AACT) was a

multicenter pilot study evaluating the feasibility of a tele-

phone-based exercise intervention in a cooperative group

setting. Sedentary (engaging in \60 min of recreational
activity/week) breast and colorectal cancer survivors were

randomized to a telephone-based exercise intervention or

usual care control group. The intervention was delivered

through the University of California at San Diego; partic-

ipants received ten phone calls over the course of the

16-week intervention. All participants underwent assess-

ment of physical activity, fitness, physical functioning,

fatigue and exercise self-efficacy at baseline and after the

16-week intervention. One hundred and twenty-one

patients were enrolled through ten Cancer and Leukemia

Group B (CALGB) institutions; 100 patients had breast

cancer and 21 had colorectal cancer. Participants random-

ized to the exercise group increased physical activity by

more than 100 versus 22% in controls (54.5 vs. 14.6 min,

P = 0.13), and experienced significant increases in fitness

(increased 6-min walk test distance by 186.9 vs. 81.9 feet,

P = 0.006) and physical functioning (7.1 vs. 2.6, P =

0.04) as compared to the control group. Breast and colo-

rectal cancer survivors enrolled in a multicenter, telephone-

based physical activity intervention increased physical

activity and experienced significant improvements in fit-

ness and physical functioning. Lifestyle intervention

research is feasible in a cooperative group setting.

Keywords Breast cancer � Exercise � Cooperative group �
Intervention � Physical functioning

Introduction

Studies suggest that lifestyle factors such as physical

activity and functional status are associated with cancer

outcomes. The Nurses’ Health Study investigators dem-

onstrated that women with early-stage breast cancer who

engaged in more than 9 MET-hours/week of physical

activity, equivalent to walking at an average pace for 3 h/

week, had a 50% lower risk of breast cancer recurrence,

breast cancer death and all cause mortality than women

who were inactive [1]. Subsequent to this report, several

additional large prospective cohort studies, encompassing

more than 15,000 patients with early-stage breast cancer,

have demonstrated that women who are physically active

J. A. Ligibel (&) � J. Meyerhardt � J. Najita � L. Shockro �
N. Campbell

Dana-Farber Cancer Institute, 450 Brookline Ave Boston,

Boston, MA 02215, USA

e-mail: jligibel@partners.org

J. P. Pierce � V. A. Newman � L. Barbier
Moores University of California at San Diego Cancer Center,

San Diego, CA, USA

E. Hacker

University of Illinois at Chicago, Chicago, IL, USA

M. Wood

University of Vermont, Burlington, VT, USA

J. Marshall

Roswell Park Cancer Institute, Buffalo, NY, USA

E. Paskett � C. Shapiro
James Comprehensive Cancer Center at the Ohio State

University, Columbus, OH, USA

123

Breast Cancer Res Treat (2012) 132:205–213

DOI 10.1007/s10549-011-1882-7

after cancer diagnosis have a 30–50% lower risk of dis-

ease-specific and overall mortality as compared to seden-

tary patients [1–5]. Similar findings have also been

reported for individuals diagnosed with colon cancer [6–8].

Additionally, poor physical functioning, linked to seden-

tary physical activity patterns [9], has long been shown to

be associated with worse survival in patients with advanced

disease [10, 11], and recent work demonstrates a link

between poor physical functioning and decreased overall

and disease-specific survival in patients diagnosed with

early-stage cancers of the breast, head and neck, colon, and

lung [12–15].

These findings have not yet been confirmed in ran-

domized trials. Many small, mostly single-institution,

studies have demonstrated that physical activity interven-

tions are safe in breast cancer patients, and that participa-

tion in an exercise intervention leads to improvements in

physical functioning, fitness, quality of life, and other end

points [16, 17]. However, there have been no randomized

trials looking at the impact of physical activity on disease

outcomes, and the single-institution trials performed to date

do not provide an adequate foundation for the design of a

large-scale trial.

The Active After Cancer Trial (NCT00548236) was

designed to evaluate the feasibility of conducting a tele-

phone-based exercise intervention study in a cooperative

group setting. The study’s primary endpoint was change in

minutes of weekly physical activity. Secondary outcomes

included change in physical functioning, fitness, anthro-

pometric measures, and quality of life.

Methods

Study population

Participants were recruited from medical oncology clinics

at ten Cancer and Leukemia Group B (CALGB) institu-

tions, including both academic institutions and community

practices, between November 2007 and November 2009.

Eligibility criteria included histological evidence of

stage I–III invasive breast, colon or rectal cancer; com-

pletion of all surgery, chemotherapy, and/or radiation

therapy between 2 and 36 months prior to enrollment

(adjuvant hormonal therapy and trastuzumab were

allowed); BMI B 47 kg/m
2
; and baseline participation in

B60 min of physical activity per week. Baseline exercise

was assessed via the Leisure Score Index (LSI) of the

Godin Leisure-Time Exercise Questionnaire (modified to

include activity duration). Patients were excluded if they

had evidence of persistent or recurrent cancer, other

malignancy, uncontrolled heart disease or other contrain-

dications to exercise.

Medical clearance was obtained from potential partici-

pants’ medical oncologists or primary care providers. The

study was approved by the Institutional Review Board at

the Dana-Farber Cancer Institute and at each of the par-

ticipating sites. Informed consent was obtained from all

participants prior to enrollment.

Study design

After enrollment, participants were randomized 1:1 to an

exercise intervention group or usual care control group.

The intervention group participated in a 16-week tele-

phone-based exercise intervention. The control group

received routine care for 16 weeks and was then offered a

telephone consultation with an exercise trainer at the end of

the control period. Subjects were stratified by type of

malignancy (breast vs. colon/rectal) and gender at the time

of study entry. Assessment of weekly minutes of physical

activity, fitness, anthropometric measures, quality of life,

physical functioning, and fatigue was performed at baseline

and after the completion of the 16-week study period.

Assessment of physical activity was conducted centrally,

and all other study measures were collected at the partic-

ipating sites. Changes in these measures over time were

compared between participants randomized to the exercise

and control groups.

Exercise intervention

Social cognitive theory and client-centered counseling

techniques [18] were used in a telephone-based interven-

tion to motivate participants to increase physical activity.

The intervention consisted of 10–11 semi-structured phone

calls over the 16-week intervention period. Calls were

delivered by behavioral counselors from a Shared Resource

at the Moores UC San Diego Cancer Center. Call duration

was 30–45 min; calls were more frequent during the early

period of the change attempt and became less frequent over

time [19]. Initial calls focused on goal setting and perfor-

mance assessment so as to build self-efficacy for exercise

behaviors, while later calls concentrated upon the adequacy

of plans for relapse prevention. Each call reviewed per-

formance on the behaviors previously discussed and

encouraged the participant to keep using self-regulatory

skills to achieve change. The telephone calls were sup-

plemented by a Participant Workbook, which included

additional information regarding the importance of exer-

cise in cancer populations, guidelines for exercise safety,

and journal pages to track weekly exercise.

The weekly exercise target was performance of at least

180 min of moderate-intensity physical activity, based on

the results of observational studies demonstrating better

survival in patients with early-stage breast and colorectal

206 Breast Cancer Res Treat (2012) 132:205–213

123

cancer who engaged in 3–5 h of moderate activity per

week [1–3, 6, 7]. Participants were allowed to choose their

own form of exercise, as long as it involved moderate to

strenuous activity (as defined in Ainsworth’s Compendium

of Physical Activities [20]). Participants were provided

with a pedometer (New Lifestyle Digi-Walker) and asked

to wear this daily. Instructions for using the pedometer

were included in the Participant Workbook and were

reviewed during the first counseling session. Participants

were asked to record the number of minutes of exercise

they performed and steps they completed each day in

journals, which were reviewed during the telephone

counseling calls.

Quality assurance

The UCSD Cancer Prevention Program counselors com-

plete an intensive 80-h program providing training in

conducting physical activity and dietary assessments, the

principles and practice of client-centered counseling, and

use of computer-based structured counseling protocols.

Counselors practice extensive role-playing before con-

ducting their first counseling session. To ensure the fidelity

of the intervention, the counselors used a computer-assisted

program that provided them with scripted questions that

required them to enter respondent answers at each point.

These scripted calls were contained within a detailed

relational database that provided the call schedule, range

checks on keyed responses, and management reports.

Measurements

Demographic data and disease and treatment information

were collected at the time of participant enrollment. The

study’s primary outcome was change in minutes of weekly

physical activity over the course of the 16-week study

period. Physical activity was measured with the 7-Day

Physical Activity Recall (7-Day PAR) Interview, an

instrument that provides information regarding the duration

and intensity of physical activity performed. The 7-Day

PAR has been widely used to quantify physical activity

levels in a variety of epidemiologic and interventional

studies [21–23] and has been demonstrated to correlate

with changes in VO2 max, body composition [21, 24, 25],

and activity patterns generated through direct observation

or activity monitors [25, 26]. 7-Day PAR interviews were

conducted over the telephone by a blinded member of the

study staff at the Dana-Farber Cancer Institute. Weekly

minutes of physical activity and weekly metabolic task

equivalent-hours (MET-hours) of activity were recorded at

baseline and at week 16 for all study

participants.

Participants also underwent a series of anthropometric,

fitness, and quality of life measurements at both time points.

Measurements were conducted by study staff at participating

institutions. Body weight and height were measured with

participants wearing street clothes and no shoes. These data

were used to calculate Body Mass Index (BMI) using the

formula BMI = weight (kg)/height (m)
2
. Waist circumfer-

ence was measured at the bending line, and hip measurement

was recorded at the point of maximum girth.

Fitness was assessed through the 6-Minute Walk Test

(6MWT), an objective evaluation of functional exercise

capacity that has been shown to be highly correlated with

the 12 Minute Walk Test [27] (from which it was derived)

and with cycle ergometer and treadmill based exercise tests

[28]. The 6MWT measures the distance an individual

walks on a level, indoor surface in 6 min. Given space

limitations, each participating site was provided with a stop

watch and 100 foot tape measure. Investigators identified a

stretch of hallway at least 50 feet in length, and participants

walked back and forth along the tape measure for 6 min.

Quality of life (QOL) and physical functioning were

assessed with the European Organization for Research and

Training, Quality of Life Questionnaire—Core 30, Version

3.0 (EORTC QLQ-C30). The EORTC QLQ-C30 is a well-

established instrument in cancer clinical trials, and the

psychometric properties have been previously reported [29,

30]. This 30-item instrument consists of five functional

scales (including physical functioning), a global QOL/

health status scale, three multi-item symptom scales, and a

number of single-item questions. Items on the multi-item

subscales are averaged and then converted to a scale with a

range of 0 to 100. Higher scores on the five functional

scales and the global QOL/health status scale represent a

higher level of functioning. Higher scores on the symptom

scales and the single-item questions indicate a higher

degree of symptomatology, and thus a poorer QOL.

Fatigue was assessed with the FACIT Fatigue Scale, a

validated 13-item scale designed to assess fatigue in terms of

its intensity and interference with performing everyday

functions [31, 32]. Exercise readiness was assessed with the

Physical Activity Self-Efficacy Questionnaire developed by

Marcus et al. [33], a five-item scale that rates participants’

confidence regarding their ability to be physically active in

various situations.

Statistical analysis

The study’s primary endpoint was change in minutes of

self-reported physical activity, as measured by the 7-Day

PAR. With a sample size of 120 patients, we had more than

80% power to detect a difference of 75 min of activity per

week (change in minutes per week of 165 vs. 90) between

the arms using a 2-sided 0.05 level Wilcoxon rank-sum

test. This was based on the following assumptions: both

groups would engage in 60 min of moderate-vigorous

Breast Cancer Res Treat (2012) 132:205–213 207

123

activity per week at baseline, the control group would

increase activity to 90 min/week over the study period

given a potential increase in activity after the completion of

adjuvant therapy, a standard deviation (SD) of 120 min/

week [34] and a drop out rate of 20% [35, 36].

Analyses for the changes in minutes of weekly activity,

fitness, anthropometric measurements and QOL outcomes

included participants for whom both baseline and week 16

measurements were available. Change scores were not

imputed for patients who had data missing at either time

point and these patients were excluded from the analysis

(n = 22). The arms were compared using a Wilcoxon rank-

sum test or two-sample t tests, after inspection of histo-

grams to assess distributional assumptions, accounting for

unequal variances with Satterthwaite’s method. Pearson

correlation coefficients were used to describe the relation-

ship between change in weekly activity and measures of

physical function, pain, fatigue, and QOL.

Descriptive statistics were used to summarize minutes of

weekly activity and number of daily steps recorded in

weekly exercise journals by women randomized to the

exercise intervention. For each participant with at least

8 weeks of recorded data, an average number of minutes of

weekly physical activity and an average number of steps

were calculated. These values were then averaged across

all evaluable participants, resulting in an average number

of minutes of exercise and an average number of steps

performed per week.

Analyses for the changes in minutes of weekly activity,
fitness, anthropometric measurements and QOL outcomes

were repeated with data from the breast cancer cohort only.

As these data were similar to the data from the combined

cohort, all analyses reported included all evaluable study

participants.

Results

One hundred and twenty-one participants enrolled in the

protocol, 100 patients with breast cancer and 21 patients

with colorectal cancer (see Consort Diagram in Fig. 1).

Baseline data are available for 121 participants. Baseline

Assessed for eligibility
(n=237) Excluded (n=116)

Not meeting inclusion criteria
(n= 72)

Refused to participate
(n=40)

Other reasons
(n=4; out of state)

Analyzed (n=51)

Excluded from analysis (n= 0)

Lost to follow-up (n= 5)

Give reasons: Did not return study
staff’s phone calls (5)

Discontinued participation (n=4)

Give reasons: withdrew upon
assignment to control group (1);
withdrew consent (2); disease recurrence
(1)

Allocated to control
(n= 60)

Participated in control
(n=51)
Did not participate in control
(n=9)

Lost to follow-up (n=6)

Give reasons: Did not return study staff’s
phone calls (6)

Discontinued intervention (n= 7)

Give reasons: withdrew consent (4),
disease recurrence (2), removed due to
medical reason (1)

Allocated to intervention
(n=61)

Received allocated intervention
(n=48)

Did not receive allocated intervention
(n=13)

Analyzed (n=48)

Excluded from analysis (n= 0)

Allocation

Analysis

Follow-Up

Enrollment: 121

Randomization

Fig. 1 Consort Diagram

208 Breast Cancer Res Treat (2012) 132:205–213

123

characteristics were distributed similarly in the exercise

and control groups (Table 1). The majority of the partici-

pants were women, had breast cancer and were treated with

chemotherapy, surgery, radiation, and hormonal therapy.

Mean age was 54 and mean BMI 30.9 kg/m
2
. Twenty-two

patients withdrew consent and/or did not complete the

study (Fig. 1). There were no significant differences in

demographic, disease or treatment variables between

patients who completed the protocol and those who drop-

ped out (data not shown).

Exercise intervention

Sixty-one participants were randomized to the exercise

intervention. Although 13 participants ultimately did not

complete the intervention, at least partial exercise data were

available for all participants. Participants attended a median

of nine calls (range 0–11). For patients who completed the

16-week intervention, the range of calls delivered was 7–11.

Forty-one of the 61 participants randomized to the exercise

intervention completed at least 8 weekly exercise journals

during the 16-week intervention period. Compliance with

pedometer use was good, with 30 of the 61 participants

randomized to the intervention group reporting daily steps

for greater than 90% of days during the 16-week interven-

tion periods, and an additional nine patients reporting data

for more than 50% of days. Participants reported a mean of

153.6 (SD 74.6) min of moderate or strenuous exercise per

week and a mean of 7392 (SD 1619) steps per day.

Physical activity, physical functioning, and fitness

Physical activity behaviors were assessed in all study

participants with the 7-Day Physical Activity Recall

Interview, physical functioning was assessed with the

EORTC QLQ C30, and fitness was assessed with the

6-Minute Walk Test. Baseline and week-16 physical

activity and physical functioning data were available for 99

patients; fitness data at both time points were available for

97 patients. At baseline, both groups were relatively inac-

tive (Table 2); control participants reported a median of

65.7 min of moderate or strenuous exercise per week on

the 7-Day PAR and intervention participants 44.9 min

(P = 0.12). Over the 16-week study period, the interven-

tion group increased activity by 121% or 54.5 (±142.0)

min versus 22% or 14.6 (±117.0) min in control patients

(P = 0.13). MET-hours/week also increased by a non-

significant amount in intervention participants versus con-

trols (3.0 ± 8.2 vs. 1.0 ± 7.6, P = 0.23).

Participants randomized to the intervention group sig-

nificantly increased fitness and physical functioning over

the course of the 16-week study period compared to con-

trols (Table 2). Intervention participants increased the

distance they walked over 6 min by 186.9 (±215.1) feet

versus 81.9 (±135.2) feet in control participants (P =

0.006). Intervention participants also experienced a sig-

nificant improvement in self-reported physical functioning

Table 1 Baseline and treatment characteristics

Exercise

(N = 61)
Control

(N = 60)

Age (±SD) 53.1 (10.8) 55.5 (10.6)

BMI (kg/m
2
) 31.2 (6.2) 30.6 (5.3)

Cancer type

Breast 50 (82%) 50 (83%)

Colon 9 (15%) 8 (13%)

Rectal 2 (3%) 2 (3%)

Sex

Female 56 (92%) 56 (93%)

Male 5 (8%) 4 (7%)

Race

White 56 (92%) 55 (92%)

Black 4 (7%) 5 (8%)

Asian 1 (2%) 0 (0%)

Highest level of education

Some/no high school 1 (2%) 3 (5%)

High school graduate 11 (18%) 6 (10%)

Technology school/some college 16 (26%) 20 (33%)

College graduate/advanced degree 33 (54%) 31 (52%)

Employment status

Working full time 22 (36%) 25 (42%)

Working part time 11 (18%) 11 (18%)

Homemaker 6 (10%) 4 (7%)

Retired 7 (11%) 13 (22%)

Disabled 3 (5%) 3 (5%)

Unemployed 4 (7%) 2 (3%)

Other 8 (13%) 2 (3%)

Tumor stage

Stage I 20 (33%) 21 (35%)

Stage II 19 (31%) 23 (38%)

Stage III 22 (16%) 16 (27%)

Surgery for primary tumor

Breast (n = 100)

Mastectomy 25 (50%) 26 (52%)

Lumpectomy 25 (50%) 24 (48%)

Colon (n = 21)

Partial colectomy 4 (36%) 7 (70%)

Low anterior resection 5 (45%) 0 (0%)

Colostomy 2 (18%) 2 (20%)

Chemotherapy 47 (77%) 43 (72%)

Radiation 42 (69%) 33 (55%)

Hormonal therapy (Breast Cancer) 31 (62%) 36 (72%)

Breast Cancer Res Treat (2012) 132:205–213 209

123

as compared to controls (change of 7.1 ± 11.4 points vs.

2.6 ± 10.2 points on the EORTC QLQ C30 physical

functioning subscale, P = 0.04) (Table 2).

Quality of life and fatigue

Participants completed quality of life, fatigue, and exercise

self-efficacy questionnaires at baseline and 16 weeks

(Table 3). At baseline, participants in both groups reported

good overall quality of life, and moderate levels of fatigue

and exercise self-efficacy. Participants in the intervention

group reported trends toward improvement in QOL

(4.3 ± 16.0 vs. -1.5 ± 18.8, P = 0.10) and exercise self-

efficacy (0.1 ± 1.0 vs. -0.3 ± 1.0, P = 0.06) as com-

pared with controls. There were no significant differences

in change scores for fatigue or other QOL subscales

between groups.

Physical measurements

Baseline and week-16 anthropometric data were available

for 99 participants (Table 4). At baseline, participants on

average weighed about 83 kg and had a BMI slightly less

than 31 kg/m
2
. There were no significant changes in

anthropometric measures over the course of the study in

either group.

Discussion

Our study tested the ability of a telephone-based physical

activity intervention to increase weekly physical activity

and improve physical functioning and fitness in 121 sed-

entary breast and colorectal survivors recruited from ten

CALGB institutions. The intervention led to statistically

significant and clinically meaningful improvements in

Table 2 Physical activity behaviors, fitness, and physical functioning at baseline and change over 16 weeks

Baseline Change over 16 weeks

Exercise (n = 48) Control (n = 51) P Exercise (n = 48) Control (n = 51) P

Physical activity (min/week)
a

44.9 ± 58.5 65.7 ± 84.1 0.12 54.5 ± 142.0 14.6 ± 117.2 0.13

MET-hours/week
b

2.7 ± 3.6 4.0 ± 5.0 0.10 3.0 ± 8.2 1.0 ± 7.6 0.23

6-Minute Walk Test (feet) 1431.9 ± 309.1 1495.2 ± 246.3 0.22 186.9 ± 215.1 81.9 ± 135.2 0.006

Physical functioning (EORTC QLQ C-30) 82.8 ± 17.8 85.8 ± 11.9 0.29 7.1 ± 11.4 2.6 ± 10.2 0.04

All data are presented as means ± SD
a

As measured by the 7-Day Physical Activity Recall

Table 3 Baseline and change data for quality of life, fatigue, and related outcomes

Baseline Change over 16 weeks
Exercise (n = 48) Control (n = 51) P Exercise (n = 48) Control (n = 51) P

EORTC QLQ C-30

Global QOL 67.1 ± 20.2 71.8 ± 18.3 0.18 4.3 ± 16.0 -1.5 ± 18.8 0.10

Pain 19.7 ± 24.6 21.9 ± 24.1 0.61 -4.9 ± 17.5 -2.6 ± 27.4 0.63

Insomnia 32.8 ± 29.5 35.0 ± 29.7 0.68 -2.1 ± 30.3 -8.5 ± 29.7 0.29

FACIT fatigue scale 36.9 ± 10.9 38.6 ± 8.5 0.34 4.4 ± 8.4 2.5 ± 6.8 0.23

Exercise self-efficacy scale 2.8 ± 1.0 2.9 ± 1.0 0.32 0.1 ± 1.2 -0.3 ± 0.8 0.06

Data are presented as means (SD)

Table 4 Physical measurements at baseline and change over 16 weeks

Baseline Change over 16 weeks
Exercise (n = 48) Control (n = 51) P Exercise (n = 48) Control (n = 51) P

Weight (kg) 83.5 ± 18.1 82.8 ± 16.0 0.82 -0.3 ± 2.9 -0.4 ± 3.1 0.85

Waist circumference (cm) 96.7 ± 20.0 94.0 ± 16.1 0.41 1.4 ± 13.2 2.3 ± 9.4 0.70

Hip circumference (cm) 110.1 ± 19.8 112.9 ± 18.5 0.41 2.4 ± 14.6 0.8 ± 11.3 0.53

Data are presented as means (SD)

210 Breast Cancer Res Treat (2012) 132:205–213

123

fitness and functional status. At baseline, both groups

walked approximately 1,450 feet over the course of 6 min,

somewhat lower than the average of 1,820 feet for women

and 1,919 feet for men reported in trials of healthy adults

[37]. Intervention participants increased their distance on

the 6-Minute Walk Test by 186.9 feet (compared to 81.9

feet in controls, P = 0.006), a change that has been cor-

related with significant improvements in functional status

in other studies [38, 39]. Self-reported physical functioning

also improved by 7.1 points in the intervention group (vs.

2.6 in controls, P = 0.04), consistent with a clinically

meaningful improvement in functional status [40, 41].

Finally, physical activity increased by 54 min/week in the

intervention group compared to 14 min/week in the control

group (P = 0.13).

The increase in weekly minutes of physical activity seen

in our study is generally consistent with other multicenter,

distance-based lifestyle interventions. In RENEW [42],

older (age C65) survivors of breast, prostate, and colorectal

cancer randomized to a telephone-based diet and exercise

intervention increased exercise by an average of 31 min/

week more than survivors randomized to an education

control group (P \ 0.001). In FRESH START [34],
patients with breast or prostate cancer randomized to a

mail-based diet and exercise intervention increased weekly

physical activity by 59.3 versus 39.2 min in the education

control group (P = 0.02). Finally, in ACTION [43] breast

cancer survivors provided with pedometers, with or with-

out tailored print materials about exercise, significantly

increased self-reported physical activity versus controls

(increase of 30 min/week controls, 89 min/week pedome-

ters, and 87 min pedometer ? printed materials, P =

0.017 and P = 0.022, respectively). However, there were

no increases in daily steps in any of the four groups.

Despite the modest increase in weekly physical activity

seen in our study, intervention participants experienced

significant improvements in fitness and physical function-

ing. Emerging data suggest that physical functioning and

physical health may be related to cancer outcomes in

patients with early-stage disease. A meta-analysis of 30

trials looking at survival and health-related quality of life

showed that physical functioning was significantly related

to survival in analyses adjusted for disease stage (HR 0.94,

95% CI 0.92–0.96, P \ 0.001) [13]. Gupta et al. [12] also
demonstrated that women with newly diagnosed breast

cancer who had higher physical functioning scores had a

mean survival of 35.5 versus 17.8 months in patients with

lower scores (P = 0.0006). These findings could explain,

at least in part, the improved survival seen in patients who

engage in even modest levels of physical activity after

cancer diagnosis. As seen in our study and others [42],

even small increases in physical activity can lead to

significant improvements in physical functioning and

fitness.

Our study also demonstrated the feasibility of conducting

lifestyle research in a cooperative group setting. Enrollment

of 121 patients was completed over 2 years, and our attri-

tion rate of 18% is similar to other exercise intervention

studies targeting inactive cancer survivors, including those

involving in-person exercise interventions [35, 36]. Partic-

ipants received a median of 9 out of a planned 10–11 calls

during the intervention period. The data completion rate was

[98% for the 99 patients who finished the study, and sites
were uniformly successful in collecting study measures,

including the 6-Minute Walk test, a novel measure for the

majority of the participating sites. This type of distance-

based lifestyle intervention could be utilized in a large-scale

cooperative group study to test the impact of behavior

change upon breast cancer outcomes.

A number of weaknesses of our study should be

acknowledged. First, the trial was powered to detect a

75-min difference in the increase in minutes of weekly

activity between the exercise and control groups. Given

that the between-group difference was only 40 min and

that the standard deviations were large, we did not dem-

onstrate that our intervention significantly increased phys-

ical activity. Although the improvements in fitness and

functional measures suggest that the exercise group did

increase activity, a larger sample would have been required

to determine the statistical significance of a 40-min dif-

ference in minutes of exercise between the groups. Addi-

tionally, our study was initially intended to enroll equal

proportions of breast and colorectal survivors, with a plan

to conduct separate analyses of our end points in both

groups. Given the slower than anticipated enrollment in the

colorectal cancer group, the majority of our participants

were breast cancer survivors. We were thus not able to

conduct a separate analysis in the colorectal cancer sub-

group, and it is not clear how applicable the results of this

study are for colorectal

cancer survivors.

In conclusion, this trial demonstrates the ability of a

telephone-based exercise intervention to improve fitness

and physical functioning in breast cancer survivors, as well

as the feasibility of conducting a lifestyle intervention in a

cooperative group setting. Sites without experience in

conducting lifestyle research were able to recruit patients

and collect study measures, including an objective fitness

measure. The lifestyle intervention led to a non-significant

increase in weekly minutes of physical activity, but par-

ticipants significantly improved functional measures linked

to survival in observational studies. Further work is needed

to determine the most effective lifestyle interventions, and

to test the impact of lifestyle change upon outcomes in

cancer survivors.

Breast Cancer Res Treat (2012) 132:205–213 211

123

Acknowledgments This work was supported by a Cancer and
Leukemia Group B Pilot Prevention Grant and by the Gloria Spivak

Faculty Support Fund at the Dana-Farber Cancer Institute.

Conflict of interest None.

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• Impact of a telephone-based physical activity intervention upon exercise behaviors and fitness in cancer survivors enrolled in a cooperative group setting

Abstract
Introduction
Methods
Study population
Study design
Exercise intervention
Quality assurance
Measurements
Statistical analysis
Results
Exercise intervention
Physical activity, physical functioning, and fitness
Quality of life and fatigue
Physical measurements
Discussion
Acknowledgments
References

A Randomized Trial to Promote Physical Activity Among Breast
Cancer Patients

Bernardine M. Pinto
The Miriam Hospital, Providence, Rhode Island, and W. Alpert

Medical School of Brown University

George D. Papandonatos
Brown University

Michael G. Goldstein
VHA National Center for Health Promotion and Disease Prevention, Durham, North Carolina

Objective: Physical activity (PA) has been shown to provide health benefits for breast cancer patients. The
effects of augmenting oncology health care provider (HCP) advice for PA with 3 months of telephone
counseling versus contact control were evaluated in a randomized trial. Methods: After receiving brief HCP
advice to become physically active, 192 women (age in years: M � 60.0, SD � 9.9) who had completed
treatment for Stage 0-IV breast cancer were randomized to telephone counseling to support PA (n � 106) or
contact control (n � 86). Their PA, motivational readiness, fatigue, and physical functioning were assessed
at baseline (before receiving HCP advice), 3, 6, and 12 months. Results: Telephone counseling produced
significant effects on the primary outcome of moderate-intensity PA of about 30 min/week at both 3 months
(95% CI � 0.44, 57.32) and 6 months (95% CI � 3.06, 61.26). Intervention participants were also more than
twice as likely as control participants to report improvements in achieving PA guidelines of at least 150
min/week at 3 (OR � 2.43, 95% CI � 1.18, 4.98) and 6 months (OR � 2.11, 95% CI � 1.00 – 4.48).
Telephone counseling was significantly more effective than contact control in increasing motivational
readiness for PA at all follow-ups (ORs � 3.93– 6.28, all ps �.003). No between-groups differences were
found for fatigue, while differential improvements in physical functioning did not remain significant past 3
months (p � .01). Conclusion: HCP advice plus telephone counseling improved PA among breast cancer
patients at 3 and 6 months and also differentially improved patients’ motivational readiness at all follow-ups,
suggesting the potential for exercise promotion in cancer follow-up care.

Keywords: breast cancer, physical activity, exercise, counseling

Supplemental materials: http://dx.doi.org/10.1037/a0029886.supp

A growing number of cancer survivors face impairments in
physical functioning, increased fatigue and reduced quality of life
(QOL), and increased risk for cardiovascular disease, obesity,
osteoporosis and future cancers (Institute of Medicine and the
National Research Council, 2006). Evidence suggests that partic-

ipating in moderate-intensity physical activity (PA) for at least
three months improves physical functioning, QOL, and mood and
reduces fatigue among cancer survivors (Agency for Healthcare
Research and Quality, 2004; Galvão & Newton, 2005; Knols,
Aaronson, Uebelhart, Fransen, & Aufdemkampe, 2005; Speck,
Courneya, Masse, Duval, & Schmitz, 2010). Cancer treatments
require frequent follow-up appointments that provide oncology
health care providers (HCPs) with opportunities to encourage
patients to change health risk behaviors. However, Sabatino and
colleagues (2007) found that only 25% of a national sample of
cancer survivors reported receiving a recommendation about ex-
ercise from their physicians.

HCPs have played a minimal role, if any, in PA interventions for
cancer patients. One study involved breast cancer patients seen at
adjuvant treatment consultation. Participants received either: a) a
recommendation to exercise, b) a recommendation plus a referral
to an exercise specialist, or c) usual care (Jones, Courneya, Fairey,
& Mackey, 2004). PA assessments at 1 and 5 weeks revealed
greater PA participation in the group that received a recommen-
dation to exercise versus usual care. In our trial, HCPs were asked
to provide PA advice to patients who had completed surgery and
adjuvant chemotherapy/radiation. Evidence suggests that it is not
practical to rely on physicians to provide more intensive interven-

Bernardine M. Pinto, Centers for Behavioral and Preventive Medicine,
The Miriam Hospital, Providence, Rhode Island, and W. Alpert Medical
School of Brown University; George D. Papandonatos, Center for Statis-
tical Sciences, Brown University; Michael G. Goldstein, Office of Patient
Care Services, VHA National Center for Health Promotion and Disease
Prevention, Durham, North Carolina.

This research was funded by a grant from the American Cancer Society
and Rays of Hope (RSGPB-03-243-01 PBP). We gratefully acknowledge
the contributions of the research staff (Susan Abdow, Stephanie Berube,
Christopher Breault, Jennifer Correia, Kelly Greenwood, and Joyce Lee).
We thank the physicians who participated in the study and assisted with
patient recruitment. The trial is registered in the Clinical Trials Registry
(NCT 002 30711).

Correspondence concerning this article should be addressed to Bernar-
dine M. Pinto, Centers for Behavioral and Preventive Medicine, The
Miriam Hospital, One Hoppin St., Coro Bldg., Suite 314, Providence, RI
02903. E-mail: bpinto@lifespan.org

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Health Psychology © 2013 American Psychological Association
2013, Vol. 32, No. 6,

616

– 626 0278-6133/13/$12.00 DOI: 10.1037/a0029886

616

http://dx.doi.org/10.1037/a0029886.supp

mailto:bpinto@lifespan.org

http://dx.doi.org/10.1037/a0029886

tions, and that instead we should involve nonphysician staff such
as telephone counselors (Marcus et al., 1998) and incorporate
interactive health technology (de Vries & Brug, 1999) in our
interventions. Hence, we extended brief HCP advice with a
3-month telephone counseling program for PA.

The use of telephone-based interventions to promote PA in a
general population has been well documented (see reviews by
Castro & King, 2002; Eakin, Lawler, Vandelanotte, & Owen,
2007; Goode, Reeves, & Eakin, 2012). The studies reviewed
showed convincingly that such interventions are not only effica-
cious, but they also offer unique advantages of increased conve-
nience and access. There are also increased opportunities for
contact anywhere a telephone is accessible and increased time
efficiency. These advantages, together with the counselor’s skills
and resources, can help promote PA among individuals who may
not be receptive to face-to-face contact or printed materials.
Telephone-based PA interventions over 6 –12 weeks have been
tested among small samples of breast cancer patients (Matthews et
al., 2007; Mock et al., 1997) with positive effects on PA (Mat-
thews et al., 2007) and reductions in patients’ anxiety, fatigue, and
sleeping difficulties (Mock et al., 1997). Telephone calls have also
been used in PA interventions offered over 6 months and longer to
breast, prostate, and other cancer survivors (Bennett, Lyons,
Winters-Stone, Nail, & Scherer, 2007; Demark-Wahnefried et al.,
2006; Morey et al., 2009) with one study showing favorable effects
at the end of a 6-month intervention (Bennett et al., 2007) and
another study with a 12-month intervention showing significant
group effects on PA and physical functioning (Morey et al., 2009).
In sum, there is evidence to support the efficacy of telephone-
based interventions at postintervention in promoting PA among
cancer survivors. However, these PA interventions did not involve
HCPs and a majority did not assess PA outcomes in the long-term.
In this study, we used a telephone counseling program whose
efficacy had been previously tested among breast cancer patients
(Pinto, Frierson, Rabin, Trunzo, & Marcus, 2005) to extend the
HCP advice. The comparison group also received HCP advice and
telephone calls to control for contact as a more conservative test of
the intervention. In addition, final assessment of outcomes oc-
curred 6 months after all intervention contact ended.

The primary purpose of this study was to examine the effects of
HCP advice to become physically active plus Telephone Counsel-
ing (Intervention) versus HCP advice plus Contact Control (Con-
trol) on self-reported minutes of PA (leisure and occupational
activity) of at least moderate-intensity at 3 months among women
who had completed breast cancer treatment. We hypothesized that
extending brief HCP advice by providing telephone counseling
specific to PA would produce stronger increases in PA at 3 months
than telephone contact of the same frequency that provided health
monitoring. Secondary aims included examining maintenance of
intervention effects on PA at 6 and 12 months. We also hypothe-
sized that the increased PA among intervention participants would
maintain over time. Other goals included examining intervention
effects on the proportion of participants who met PA guidelines
and on participants’ motivational readiness for PA at 3 months, 6
months, and 12 months. We hypothesized that a larger proportion
of intervention participants would meet PA guidelines, and that the
intervention group would progress further in motivational readi-
ness for PA. Finally, we sought to examine intervention effects on
self-reported physical functioning and fatigue at follow-up. We

hypothesized that the intervention group would report improved
physical functioning and reduced fatigue at follow-ups compared
with the control group.

Methods

Design

We conducted a randomized trial offering all participants HCP
advice for PA and then compared: (a) 12 weeks of additional
Telephone Counseling, and (b) Contact Control. Assessments were
conducted at baseline, posttreatment (3 months), at 6 months and
12 months. Institutional Review Boards at the Miriam Hospital and
Women and Infants Hospital approved the study. The study was
conducted in accordance with the Helsinki Declaration from
2004 –2009.

Recruitment

Participants were recruited by informational letters sent by
oncologists and surgeons to their patients, and by in-person re-
cruitment at a hospital-based oncology clinic. HCPs were asked to
review their nonurgent follow-up care schedules and to identify
women who had completed breast cancer treatment, had no current
evidence of disease, and were expected to live � 12 months.
Letters were mailed to these patients approximately three months
before their next visit. If patients were interested in the study, they
were asked to contact the study staff who conducted an eligibility
screen by telephone. Eligibility criteria: 1) female aged � 18
years, 2) completed primary and adjuvant treatment for breast
cancer (patients on hormone treatment such as Tamoxifen were
eligible), 3) � 5 years since treatment completion, 4) able to read
and speak English, 5) provided consent for medical chart review,
6) able to walk unassisted, 7) were relatively inactive (�30 min/
week of vigorous-intensity exercise or �90 min/week of
moderate-intensity exercise), and 8) had access to a telephone.
Participants were excluded if they had a prior history of cancer or
if they had a medical or current psychiatric illness (e.g., cardio-
vascular disease, diabetes) that could hinder compliance with the
study protocol.

We completed 351 initial telephone screens to determine study
eligibility (see Figure 1). Of those screened, 192 (54.7% of phone
screens, 71% of eligible respondents) were eligible, interested, and
eventually randomized. The study was designed to have 80%
power to detect a between-groups difference in change scores of
0.35 SD units at the 5% level of significance, based on cross-
sectional comparisons at 3 months. Due to recruitment difficulties,
the study goal of 300 based on N � 125/group at 3 months
(starting from N � 150/group at baseline) could not be met within
the time available. Based on 83 control and 88 intervention par-
ticipants with valid 7-day physical activity recall (PAR) measures
at 3 months (see Figure 1), the minimum detectable between-
groups difference in change scores rose to 0.42 SD units. Given the
observed 3-month change-score SD of 106 min/week, this trans-
lates to a 45-min difference in 3-month change scores, before
taking into account the additional power offered by the repeated
measures design.

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617PHYSICAL ACTIVITY INTERVENTION

Procedure

After providing informed consent, participants obtained medical
clearance from their oncologist. All participants received PA ad-
vice from an oncologist/surgeon during a clinic visit (n � 100) or
advice documented in a letter (n � 92) after they were referred for
study participation during a clinic visit. After receiving HCP
advice, they were randomly assigned to the two study arms using
a centrally administered randomization procedure that stratified on
prior chemotherapy status (yes/no) and PA level (participants
classified as active vs. not based on a PA threshold of 30 min/
week). HCPs and staff conducting the assessments were blinded to
participants’ group assignments. Participants and intervention co-
ordinators were not blinded to group assignments.

HCP Advice

Oncologists and surgeons (n � 14, 29% women, mean years in
practice � 15.6, SD � 8.9, mean age � 50.8, SD � 9.6) at three
local hospitals and two private practices who were invited to
participate in the study received training (15–30 min) in providing

brief PA advice (�5 min). The brief motivational counseling
protocol was derived from the 5As counseling strategy (address
the agenda, assess, advise, assist and arrange follow-up) used
previously for training physicians (Goldstein et al., 1999; Pinto,
Goldstein, Ashba, Sciamanna, & Jette, 2005). The HCP’s role was
to provide patients a brief message about PA benefits, recommend
30 min of moderate-intensity PA on most days of the week, and
arrange for follow-up with study staff.

Participants who were recruited via informational letters re-
ceived HCP advice at the next regularly scheduled clinic visit. At
this visit, providers were cued by prompts placed on patients’
charts to deliver PA advice. Documentation of message delivery
was recorded on the chart prompt. Providers were allowed to drop
patients from the study if the goal of moderate-intensity PA would
be unsafe for the patient. After completing the clinic visit, each
participant was met by research staff, the chart prompt was col-
lected and her randomization status was determined. For partici-
pants recruited on-site (n � 92), HCPs recommended the study to
patients seen in clinic. If interested, eligible and enrolled in the
study, the participant was given a letter from her HCP document-

Initial phone screen for eligibility, n=351

Ineligible: 23.1% (n=81)
Too active=36
Medical issues=16
>10 years postdiagnosis=2
Ongoing psychological issues=3
No English fluency=2
Not able to exercise= 3
Enrolled in another study=6
HCP not participating=1
Other=12

Eligible at phone screen: 76.9% (n=270)

Eligible and randomized: 71.1% (n=192)

Not randomized: 28.9% (n=78)
No interest=18, Too busy=18
Lost contact=8, Family issues=5
Medical issues=4, Other reason=11
Reason unknown=14

TC Group (n=106) CC Group (n=86)

12-week PA Counseling 12-week Contact

Post-treatment assessment: 83.9% (n=89)
Attrition=17 (Lost contact=8, family issues=4,
cancer=2, no interest=2, too busy=1)
Primary outcome analyzed: 83.0% (n=88)

Post-treatment assessment: 97.6% (n=84)
Attrition=2 (Lost contact=2)
Primary outcome analyzed: 96.5% (n=83)

Monthly PA calls for 3 months
Monthly calls for 3 months

Oncology HCP advice
(in-person or by letter)

Assessment at 6 months: 81.1% (n=86)
Attrition=3 (Lost contact=1, family issues=1, no interest=1)
Primary outcome analyzed: 80.2% (n=85)

Assessment at 6 months: 93.0% (n=80)
Attrition=4 (No interest=2, too busy=1, surgery=1)
Primary outcome analyzed: 89.5% (n=77)

Assessment at 12 months: 79.2% (n=84)
Attrition=2 (Lost contact=1, cancer=1)
Primary outcome analyzed: 77.4% (n=82)

Assessment at 12 months: 90.6% (n=78)
Attrition=2 (too busy=1, death=1)
Primary outcome analyzed: 88.4% (n=76)

Figure 1. Flow diagram of participant recruitment, randomization, and retention.

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618 PINTO, PAPANDONATOS, AND GOLDSTEIN

ing “brief advice” elements (advise, assist and arrange follow-up/
referral to study staff) and randomized. Advice documented in a
letter was used to reduce delays in study enrollment since the next
clinic visit may have been more than 3 months later.

HCP Advice Plus Telephone Counseling (Intervention)

These participants received in-person instructions on how to
exercise at a moderate-intensity level, monitor heart rate, and how
to warm up before and cool down after PA. They were given home
logs to monitor PA participation and a pedometer (Digiwalker,
Yamax Corporation, Tokyo, Japan). The intervention was individ-
ualized to the participant’s baseline PA (and motivational readi-
ness) such that, inactive participants were encouraged to be phys-
ically active for at least 10 min on at least 2 days/week (these goals
were higher for those who were physically active at baseline), and the
goals were gradually increased over the 12 weeks to 30 min/day on at
least 5 days/week (U.S. Department of Health and Human Services,
1996). For participants who reported some level of PA at baseline, the
exercise goals negotiated by the interventionist were higher. Hence,
starting points and rates of PA progression varied across participants
because these were individualized to increase the motivation and
confidence of the participants. The counseling promoted moderate-
intensity aerobic PA at 55– 65% maximum heart rate such as brisk
walking, biking, or swimming.

Each participant received eight telephone calls over 12 weeks
(weekly for 4 weeks, biweekly for 8 weeks) from Intervention
Coordinators to support PA adoption. Counseling was based on the
Transtheoretical Model and Social Cognitive Theory (Bandura,
1986; Prochaska & DiClemente, 1983), and it was tailored to each
participant’s motivational readiness (Marcus & Simkin, 1993).
The counseling focused on strengthening self-efficacy for PA, and
it trained participants in techniques such as self-monitoring of PA,
setting PA goals, and planning for exercise. Cognitive processes of
change were emphasized for participants in Contemplation, and
behavioral processes were emphasized for those in Preparation
(Marcus & Simkin, 1993). Specific components from motivational
interviewing (conviction of the importance of PA to cancer recov-
ery and confidence in becoming/staying active) were also assessed
during the calls.

The PA counseling followed a structured format covering the
following topics: assessment of the past week’s PA (and motiva-
tional readiness), assessment of health problems, exploration of
barriers to PA, assessment of the participant’s conviction of the
importance of PA, negotiation of PA goals for the following
week(s), assessment of the participant’s confidence in achieving
the goals, and review of the tip-sheets that were sent to the
participant. If participants reported physical symptoms such as
chest pain, they were referred to their physician for clearance to
resume study participation.

Participants were mailed a PA and a cancer survivorship
tip-sheet on topics such as body image, each week over the
12-week intervention. Finally, a letter summarizing the partic-
ipant’s progress was sent to her at weeks 2, 4, 8, and 12. After
the 3-month assessments were completed, monthly phone calls
over the next 3 months were provided to reinforce regular PA
and prevent lapses.

HCP Advice Plus Contact Control Group (Control)

These participants received eight calls over 12 weeks (weekly
for 4 weeks, biweekly for 8 weeks) during which the Symptom
Questionnaire (Winningham, 1993) was administered to monitor
problems such as headaches. Interventionists were trained not to
discuss PA with this group. If the participants reported PA, the
interventionist listened but did not provide any counseling related
to PA. The goal was to match contact frequency with the inter-
vention group, with no attempt made to match call duration across
groups. In addition, participants received cancer survivorship tip-
sheets. After the 3-month assessment, they also received monthly
phone calls for 3 months, during which the Symptom Question-
naire was administered.

Intervention Delivery

All telephone calls to study participants were audio-taped, and
25% of these tapes were randomly selected for review by the
principal investigator and a co-investigator to ensure fidelity to
protocol. In addition, participant issues were discussed during
weekly staff meetings.

Measures

Disease and treatment variables (from medical records) and
demographic information were obtained at baseline. At baseline
and subsequent assessments, body weight and height were mea-
sured. Participants received small incentives (e.g., $10 gift cards)
for completing the assessments which included:

Seven-Day Physical Activity Recall (7-day PAR;Blair et al,
1985). This interviewer-administered measure (Sallis et al.,
1985; Sarkin, Campbell, & Gross, 1997) assesses hours spent in
sleep as well as moderate, hard, and very hard activity (leisure and
occupational) over the past week. We were interested in the
weekly minutes of at least moderate-intensity PA, which we ana-
lyzed as a continuous outcome (primary outcome) and as a dichot-
omous indicator of whether participants met recommendations
(U.S. Department of Health and Human Services, 1996) of at least
150 min/week of moderate-intensity PA.

Stage of Motivational Readiness for PA (Marcus, Rossi,
Selby, Niaura, & Abrams, 1992). This reliable and valid mea-
sure assesses an individual’s motivational readiness for PA (Mar-
cus & Simkin, 1993). It classifies individuals into one of five
stages: precontemplation (individuals who do no PA and do not
intend to start), contemplation (those who do not participate in PA
but intend to start), preparation (those who participate in some PA
but not regularly), action (those who currently participate in reg-
ular activity, but have done so for less than 6 months), and
maintenance (those who have participated in regular PA for 6
months or longer). For the purposes of this study, regular PA was
defined as at least 30 min of moderate-intensity exercise on � 5
times per week. Since movement into Action/Maintenance has
been significantly associated with fitness improvements (Marcus
& Simkin, 1993), we modeled motivational readiness as dichoto-
mous, contrasting those who successfully transitioned into Action/
Maintenance with those that did not.

MOS 36-Item Short Form Health Survey (SF-36; McHor-
ney, Ware, & Raczek, 1993; Ware & Sherbourne, 1992). This
assesses eight health concepts (e.g., physical functioning, bodily

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619PHYSICAL ACTIVITY INTERVENTION

pain). We used the Physical Functioning subscale (PF), as cancer
survivors who adopted exercise have shown improvements on this
subscale (Pinto, Trunzo, Reiss, & Shiu, 2002). This measure yields
a continuous variable that ranges from a low score of 0 (limitations
in physical activities) to a high score of 100 (no limitations).

Functional Assessment of Cancer Therapy Scale-Fatigue
(FACT-F). This 13-item scale is a brief, reliable, and valid
measure of the physical and functional effects of fatigue. It has
strong internal consistency, and it shows a significant positive
relationship with other measures of fatigue (Yellen, Cella, Web-
ster, Blendowski, & Kaplan, 1997). Scores on this measure range
from 6 (high fatigue) to 52 (low fatigue).

Analyses

T tests for continuous variables and �2 tests for categorical
variables were used to examine the success of the randomization
procedure in balancing participants’ characteristics, including
baseline values of the outcomes of interest (see Table 1). Similar
analyses were used to compare retained participants versus drop-
outs.

Longitudinal trajectory modeling of continuous outcomes was
conducted using Linear Mixed Effects (LME) models, as imple-
mented in Splus 8.2 (Insightful Corporation, 2007). Mean change
scores from baseline were adjusted for baseline values of each
outcome, and they were calculated separately by treatment group
at each follow-up. Any variables showing significant between-
groups differences at baseline were also included as potential
confounders. Subject-specific random intercepts were used to ac-
commodate within-subject correlation across time.

Of note, LME models employ likelihood-based estimation pro-
cedures that use all available data to produce consistent estimates
of the regression coefficients (Daniels & Hogan, 2008; Little &
Rubin, 2002). Although they remain sensitive to drop out patterns
that depend on the missing outcome itself, they are superior to
completers-only analyses or intention-to-treat approaches that as-
sign a prespecified score to the missing data.

Longitudinal binary outcomes were analyzed using Generalized
Estimating Equation (GEE) methodology, as implemented in the
Correlated Data Library of Splus 8.2 (Insightful Corporation,
2007). Logistic regression models with a working independence
correlation matrix were used to estimate the effect of baseline PA
levels and study arm on the odds of meeting or exceeding PA
guidelines at each follow-up (U.S. Department of Health and
Human Services, 1996, 2008). A similar GEE procedure was used
to analyze movement into Action/Maintenance by study arm,
controlling for stage of change at baseline (Contemplation vs.
Preparation).

Results

Sample Characteristics

As seen in Table 1, 192 women (mean age � 60.0 years, SD �
9.9, mean time since diagnosis � 2.9 years, SD � 2.1) were
assigned to either intervention (n � 86) or control (n � 106), using
a stratified randomization scheme. Overall, 22 intervention and
eight control participants withdrew or were dropped from the trial
(see Figure 1). Attrition in the control group was consistently low

across time, whereas the intervention group experienced higher
dropout at 3 months (n � 17), and limited losses thereafter.
Within-group comparisons in the intervention arm, in terms of
baseline characteristics, showed that 26% of dropouts had a mas-
tectomy at 3 months versus 12% of retained participants (p � .1).
Two participants sustained minor injuries related to falling off a
treadmill, and one died during the trial for reasons unrelated to
study participation.

Analyses revealed no statistically significant between-groups
differences on demographic variables or outcomes at baseline.
However, intervention versus control differences in chemotherapy
rates (55% vs. 66%) and full-time employment (FTE) status (55%
vs. 47%) were deemed meaningful enough to warrant further
examination of these variables as potential confounders of the
treatment-outcome relationship. Results suggested that chemother-
apy did not affect any outcome of interest. However, FTE status
affected all outcomes other than fatigue, at least during the 12-
week intervention period. Therefore, longitudinal trajectories of
study participants were adjusted not only for baseline values of
each outcome, but also for FTE status, where warranted.

PA Outcomes

Seven-day PAR. Intervention participants outperformed con-
trol participants by about 30 min/week of at least moderate inten-
sity PA at both 3 months (p � .048) and 6 months (p � .032), but
this beneficial telephone counseling effect dissipated at 12 months
(p � .574). For illustrative purposes, we also included in Table 2
covariate-adjusted intervention and control change score trajecto-
ries for a reference group of participants not in FTE with baseline
PA levels set at the overall sample mean (45 min/week). These can
be combined with the reported baseline PA and FTE effects to
construct anticipated PA trajectories for any study participant of
interest. For every additional hour by which a participant’s base-
line PA level exceeded the sample mean, anticipated PA increases
at follow-up were reduced in both study arms by 16 min at 3
months (p � .03), 35 min at 6 months (p � .001), and 28 min at
12 months (p � .001). In addition, FTE status increased weekly
PA levels by 46 min at 3 months (p � .002), but its effect was
attenuated at both 6 months (p � .604) and 12 months (p � .643).

Meeting PA guidelines. Given the sensitivity of average PA
levels to the presence of outliers, we also estimated a logistic
regression model in which the binary response was an indicator of
whether a participant was able to meet or exceed guidelines of 150
min/week of PA at follow-up (U.S. Department of Health and
Human Services, 2008). Results in Table 3 suggest beneficial
intervention effects at 3 months (OR � 2.43, p � .016) and 6
months (OR � 2.11, p � .05), but not at 12 months (OR � 1.16,
p � .704) for a reference group of participants not in FTE report-
ing mean PA levels at baseline. As expected, higher PA at study
entry made it even more likely that a participant would succeed in
meeting guidelines at follow-up: For every hour by which a
participant’s baseline PA exceeded the sample mean of 45 min/
week, the odds of meeting guidelines at follow-up rose by 11% to
23% across study arms, depending on time point. Finally, FTE
status more than doubled the odds of meeting guidelines at 3
months (OR � 2.33, p � .02), but its effect was attenuated at both
6 months (p � .366) and 12 months (p � .477).

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620 PINTO, PAPANDONATOS, AND GOLDSTEIN

Table 1
Sample Characteristics at Baseline (N � 192)

Characteristic/Category

Groupsa

CC (n � 86) TC (n � 106)

p-valueNo. % No. %

Race/Ethnicity
Non-Hispanic White 80 93 100 95 .79
Non-Hispanic Black 4 5 3 3
Hispanic 2 2 2 2

Marital status
Single 7 8 6 6 .81
Married/Living with partner 59 69 79 75
Divorced/Separated 12 14 12 11
Widowed 8 9 9 8

Employment status
Employed full-time 47 55 50 47 .27
Employed part-time 10 12 20 19
Unemployed 4 5 8 8
Retired 20 24 18 17
Homemaker/Medical leave 4 5 10 9

Educational level
High School Diploma 16 19 19 18 .99
Vocational/Trade School 5 6 6 6
Some college 24 28 28 26
Associate Degree 10 12 11 10
Bachelor Degree 14 16 20 19
Graduate School 17 20 22 21

Household income
Less than $29,999 8 10 13 13 .39
$30,000–$39,999 7 9 11 11
$40,000–$49,999 15 19 10 10
Over $50,000 49 62 63 65

Age in years
Mean (SD) 55.9 (9.9) 56.1 (9.9) .89

Body mass index
Mean (SD) 28.7 (5.1) 29.6 (6.2) .28

Cancer stage
0 12 14 12 11 .89
I 33 38 41 39
II 34 40 44 42
III/IV 7 8 9 8

Cancer treatmentb

Lumpectomy 66 77 76 73 .68
Lumpectomy with dissection 44 51 53 50 .96
Mastectomy 28 33 34 33 .91
Mastectomy with reconstruction 6 7 6 6 .95
Radiation 63 73 76 72 .94
Chemotherapy 47 55 69 66 .16
Hormone treatment 70 81 78 74 .32

Years since diagnosis
Mean (SD) 2.9 (2.1) 3.0 (2.2) .72

Motivational readiness
Contemplation 67 78 81 76 .13
Preparation 13 15 23 22
Action/Maintenance 6 7 2 2

PA guidelines
�150 PAR min/week 79 92 100 94 .70
�150 PAR min/week 7 8 6 6

7-day PAR (min/week)
Mean (SD) 46.8 (62.5) 42.9 (59.4) .67

FACT-F
Mean (SD) 38.1 (11.6) 39.3 (9.9) .47

SF-36 PF
Mean (SD) 72.8 (22.8) 77.2 (19.5) .15

Note. TC � Telephone Counseling; CC � Contact Control; PA � Physical Activity; PAR � 7-day PAR; FACT-F � Functional Assessment of Cancer
Therapy Scale-Fatigue; SF-36 PF � MOS 36-Item Short Form Health Survey: Physical Functioning subscale.
a Percentages have been calculated on cases with available data. b Each patient may have received more than one treatment; percentages do not add to
100.

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621PHYSICAL ACTIVITY INTERVENTION

Motivational readiness. All but eight participants were in
either the Contemplation or Preparation stage at study entry, and a
secondary study goal was to move them (N � 184) to Action or
Maintenance stage at follow-up (Prochaska & DiClemente, 1983).
Telephone counseling appears to have produced long-lasting ef-
fects on motivational readiness among a reference group of par-
ticipants not in FTE that joined the study while in Contemplation:
As seen in Table 3, such participants were much more likely to
have reached Action/Maintenance at 3 months (OR � 4.45, p �
.001) and 6 months (OR � 3.93, p � .003) if assigned to the

intervention than the control arm, and these intervention effects
were strengthened further at 12 months (OR � 6.28, p � .001).
Participants entering the study in Preparation were significantly
more likely to move to Action/Maintenance than those in Contem-
plation, whether at 3 months (OR � 3.76, p � .002), 6 months
(OR � 2.57, p � .033), or 12 months (OR � 2.64, p � .041). In
contrast, FTE status more than doubled the odds of reaching
Action/Maintenance at 3 months (OR � 2.58, p � .02), but its
effect was attenuated at both 6 months (p � .373) and 12 months
(p � .725).

Table 2
Point Estimates and 95% Confidence Intervals for Change Scores From Baseline to Follow-Upa

Outcome/Group

Follow-up

3 Months 6 Months 12 Months

Mean 95% CI Mean 95% CI Mean 95% CI

7-day PAR (min/week)
TC 59.70 (35.59, 83.80) 56.64 (32.22, 81.07) 44.06 (19.22, 68.89)
CC 30.82 (5.13, 56.51) 24.48 (�1.43, 50.40) 35.61 (9.04, 62.17)
TC vs. CC 28.88 (0.44, 57.32) 32.16 (3.06, 61.26) 8.45 (�20.95, 37.86)
Baseline PARb �15.83 (�30.36, �1.30) �35.25 (�49.85, �20.64) �27.76 (�42.40, �13.13)
FTE vs. not 46.10 (17.67, 74.52) 7.70 (�21.34, 36.73) �6.96 (�36.32, 22.41)

SF-36 PF
TC 3.73 (�0.39, 7.86) 4.79 (0.64, 8.95) 3.87 (�0.32, 8.06)
CC �2.74 (�7.14, 1.65) 1.09 (�3.42, 5.59) 1.11 (�3.40, 5.62)
TC vs. CC 6.48 (1.60, 11.35) 3.71 (�1.27, 8.69) 2.76 (�2.26, 7.77)
Baseline SF-36 �0.40 (�0.52, �0.29) �0.35 (�0.46, �0.23) �0.35 (�0.47, �0.23)
FTE vs. not 6.49 (1.60, 11.38) 4.08 (�0.93, 9.09) 1.75 (�3.29, 6.80)

FACT-F
TC 4.53 (2.88, 6.18) 3.84 (2.17, 5.51) 3.69 (1.98, 5.39)
CC 3.41 (1.70, 5.13) 1.95 (0.18, 3.72) 1.44 (�0.31, 3.20)
TC vs. CC 1.12 (�1.26, 3.50) 1.89 (�0.54, 4.33) 2.44 (�0.20, 4.69)
Baseline FACT-F �0.40 (�0.51, �0.29) �0.37 (�0.48, �0.26) �0.40 (�0.51, �0.29)

Note. TC � Telephone Counseling; CC � Contact Control; FTE � Full-time employment; PAR � 7-day PAR; SF-36 PF � MOS 36-Item Short Form
Health Survey Physical Functioning subscale; FACT-F � Functional Assessment of Cancer Therapy Scale-Fatigue.
a Boldface estimates denote p-values significant at � � .05. b Baseline PAR expressed in hours/week.

Table 3
Longitudinal Logistic Regression Models Predicting Achievement of PA Guidelines and Movement to Action/Maintenance at Follow-Upa

Outcome/Coefficientb

Follow-up
3 Months 6 Months 12 Months

OR 95% CI OR 95% CI OR 95% CI

PA guidelines
TC 0.43 (0.23, 0.82) 0.39 (0.21, 0.73) 0.33 (0.17, 0.65)
CC 0.18 (0.09, 0.35) 0.18 (0.09, 0.36) 0.29 (0.15, 0.54)
TC vs. CC 2.43 (1.18, 4.98) 2.11 (1.00, 4.48) 1.16 (0.54, 2.52)
Baseline PAR 1.23 (1.08, 1.39) 1.12 (1.02, 1.23) 1.11 (1.03, 1.19)
FTE vs. not 2.33 (1.14, 4.76) 1.41 (0.67, 2.98) 0.76 (0.35, 1.63)

Action/Maintenancec

TC 0.27 (0.13, 0.57) 0.28 (0.14, 0.59) 0.35 (0.16, 0.74)
CC 0.06 (0.02, 0.15) 0.07 (0.03, 0.19) 0.06 (0.02, 0.15)
TC vs. CC 4.45 (2.02, 9.80) 3.93 (1.57, 9.80) 6.28 (2.29, 17.24)
Prep. vs. Con 3.76 (1.59, 8.86) 2.57 (1.08, 6.14) 2.64 (1.04, 6.70)
FTE vs. not 2.58 (1.16, 5.74) 1.45 (0.64, 3.26) 1.16 (0.50, 2.70)

Note. TC � Telephone Counseling; CC � Contact Control; FTE � Full-time employment; Con � Contemplation; Prep. � Preparation; PA � Physical Activity;
PAR � 7-day PAR.
a Boldface estimates denote p-values significant at � � .05. b Baseline PAR expressed in hours/week. c Model estimated among N � 184 participants
in Contemplation or Preparation at study entry.

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622 PINTO, PAPANDONATOS, AND GOLDSTEIN

Psychosocial Outcomes

Physical functioning. Intervention participants outperformed
control participants by 6.48 units on the SF-36 PF scale at 3
months (p � .01), but group differences narrowed at 6 months
(p � .147) and 12 months (p � .497). Table 2 displays covariate-
adjusted intervention and control change score trajectories for a
reference group of participants not in FTE reporting with average
SF-36 levels at baseline (75.21 units). Trajectories for other study
participants can be constructed by noting that for every additional
unit by which a participant’s baseline SF-36 score exceeded the
sample mean, anticipated SF-36 PF increases in both study groups
were reduced by 0.35– 0.40 units at follow-up across study arms
(all ps � .001). In addition, FTE status increased physical func-
tioning by 6.49 units at 3 months (p � .01), but its effect was
attenuated at both 6 months (p � .112) and 12 months (p � .497).

Fatigue. No significant group differences in fatigue levels
were found at follow-up. Illustrative intervention and control
change score trajectories are depicted in Table 2 for a reference
group of participants not in FTE reporting mean FACT-F scores of
38.76 units at baseline. Trajectories for other participants can be
calculated by noting that for every additional unit by which a
participant’s baseline FACT-F score exceeded the sample mean,
anticipated FACT-F increases in both study groups were reduced
by 0.37– 0.40 units at follow-up (all ps � .001).

Intervention Delivery

The proportion of participants receiving in-person HCP advice
was balanced across study arms, with negligible intervention ver-
sus control differences (51.12% vs. 52.83%, p � .93). In-person
HCP advice, as evidenced by completed chart prompts, was de-
livered to 98% of the participants who received in-person advice
(mean duration of advice � 4.7 min, SD � 1.4). Eighty-six percent
of the participants reported that their HCPs explained the health
benefits of PA, and 96% were satisfied with the advice. During the
3-month intervention phase, a mean of 6.7 calls (SD � 1.81) were
delivered to intervention participants and 7.1 calls (SD � 1.3) to
control participants (p � .07; max. possible � eight calls). As
expected, calls in the intervention arm were of longer duration
(M � 15.0 min, SD � 5.8) than calls in the control arm (M � 9.0
min, SD � 3.9, p � .001).

Discussion

Our primary goal was to examine the effects of HCP advice plus
Telephone Counseling (Intervention) versus HCP advice plus Con-
tact Control (Control) on participants’ PA at 3 months. HCPs were
able to provide brief exercise advice, which the participants found
satisfactory. We found that intervention participants outperformed
control participants by about 30 min/week of at least moderate
intensity PA at 3 months and 6 months, but that this effect
dissipated at 12 months. In practical terms, this translates to PA
increases of one additional day/week in terms of USDHHS guide-
lines (U.S. Department of Health and Human Services, 2008) that
recommend moderate-intensity PA of at least 30 min/day on five
or more days/week, or a minimum of 150 min/week overall.
Results were consistent across continuous and binary measures of
PA (average 7-day PAR levels vs. proportion meeting PA guide-

lines of 150 min/week), which is reassuring, since the former can
be susceptible to the influence of outliers.

On motivational readiness for PA, the outcome most closely
related to the theoretical basis underlying the intervention, we
found strong intervention effects that were maintained throughout
the 12-month study period. In particular, intervention participants
outperformed control participants in terms of moving from Con-
templation/Preparation at study entry to Action/Maintenance at
follow-up, a change in motivational readiness previously associ-
ated with fitness improvements (Marcus & Simkin, 1993). The
apparent discrepancy in the strength of intervention effects on
self-reported PA levels and on motivational readiness for PA at 12
months may be due to differences over the reference assessment
period (the previous week in the PAR vs. the previous 6 months for
moving to the Action/Maintenance stage of motivational readiness
for PA). As PA levels were elevated in the intervention group at 6
months relative to 12 months, motivational readiness at 12 months
may be capturing PA increases at the previous assessment point
not included in the 7-day PAR administered at 12 months.

The only other known study in which HCPs provided PA advice
to breast cancer patients, had effects assessed at 1 and 5 weeks
(Jones et al., 2004), so it is difficult to compare the results across
studies, but it is clear that our study—which followed patients for
much longer—found positive effects of HCP advice plus telephone
counseling on PA at 3 months and 6 months. When considering
telephone-based interventions and short-term effects (3 months),
stronger effects on PA were found in our previous 12-week tele-
phone counseling intervention among breast cancer patients (Pinto,
Frierson, et al., 2005). Significant effects on PA were also found in
previous telephone counseling studies among breast cancer pa-
tients at 6 weeks (Mock et al., 1997) and at 12 weeks (Matthews
et al., 2007). In studies using other intervention approaches such as
the effects of exercise recommendations alone, print materials
alone, pedometers alone, and a combination of print materials and
pedometers among breast cancer survivors (Vallance, Courneya,
Plotnikoff, Yasui, & Mackey, 2007), larger group differences (39
to 57 min/week across groups) were found at 3 months. When
considering PA outcomes at 12 months, a group difference of 13
min was achieved in a sample of 641 overweight, older long-term
cancer survivors who received a 12-month PA and dietary inter-
vention via telephone and print materials or a delayed intervention
(Morey et al., 2009). These interventions did not involve the HCP,
and overlooking the HCP may present a missed opportunity for
supporting a healthy behavior such as exercise.

It is clear that the significant intervention effects in helping
breast cancer survivors meet PA guidelines at 3 months and 6
months dissipated at 12 months. One call/week over 12 weeks had
produced significant increases in PA in a prior study among breast
cancer survivors (Pinto, Frierson, et al., 2005). We had reduced the
number of calls to eight in this trial which may account for weaker
effects. Another explanation is that the inability to detect between-
groups differences was driven by the increased PA reported by
control participants over time. Though intriguing, this increase
should not be interpreted to suggest that brief advice from HCPs is
sufficient to increase long-term PA, because control participants
received not only HCP advice, but also similar frequency of
contact with research staff as intervention participants. This was
done to provide a more conservative test of the intervention.
However, it is possible that the contacts kept PA salient for control

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623PHYSICAL ACTIVITY INTERVENTION

participants and reduced the ability to detect differential interven-
tion effects. The true test of this explanation would involve a 3-arm
study: HCP advice plus Telephone Counseling, HCP advice plus
Contact Control, and HCP Advice alone.

Study goals included examining intervention effects on psycho-
social outcomes. Group differences in fatigue were nonsignificant,
and the intervention effects on self-reported physical functioning
were not maintained past 3 months. Our study participants were
not screened for high levels of fatigue and/or poor physical func-
tioning. Mean fatigue scores at baseline were similar to those in
another PA trial for breast cancer patients initiating adjuvant
chemotherapy in which significant improvement in fatigue in the
PA group was not found (Courneya et al., 2007). Both study
groups showed improvements in fatigue, and in the absence of a
control group that received no intervention, these results are in-
conclusive. The strength of the effect size of exercise interventions
on cancer patients’ fatigue has been found to be inconsistent and
highly heterogeneous across studies (0.06 –2.26), and it may be
linked to a “take all comers” approach, that is, patients in the
studies may have had low fatigue levels (Speck et al., 2010).
Similarly, our study sample’s physical functioning was high at
baseline (compared with normative data; Ware, Kosinski, &
Dewey, 2000), suggesting possible “ceiling” effects.

The higher attrition at 3 months among participants receiving
telephone counseling rather than contact control (16.1% vs. 2.3%)
was surprising (see Figure 1 for reasons), and suggests that study
demands may have been too burdensome for some breast cancer
participants. Although higher attrition among intervention partic-
ipants is not uncommon (Dubbert, Morey, Kirchner, Meydrech, &
Grothe, 2008), retention was at 94% in a previous trial using
telephone counseling (12 weekly calls in a 3-month intervention)
to promote PA among breast cancer patients (Pinto, Frierson, et al.,
2005).

The association of working full-time and increased PA at 3
months (but not thereafter) was surprising. Finding time to exer-
cise is often a barrier for individuals who work, and this barrier
may be stronger among women who also have household respon-
sibilities (Dishman, 1990). But it is also possible that the women
who worked full-time may have had better health and fewer
comorbidities than those who were not working full-time.

This study, which is one of the first to promote PA in collabo-
ration with oncology follow-up, clearly showed that motivated
HCPs were able to provide brief advice to their patients (98%
completed chart prompts). The duration of advice was brief, as
intended, and participants were generally satisfied with the advice.
The advice was associated with short-term and long increases in
PA in both groups who received calls focusing either on PA or
contact control. The improvement in PA in the control arm was
surprising, but it may also represent the growing awareness of the
relevance of PA for cancer recovery. Future studies may want to
test the efficacy of HCP advice in the absence of a contact control
arm on short-term and long-term outcomes. If such studies also
focus on psycho-social effects such as fatigue and physical func-
tioning, it is important to also recruit patients who report high
levels of fatigue and low physical functioning in order to avoid
“floor” and “ceiling” effects.

Study limitations include an actively recruited sample of pa-
tients who were able to obtain physician consent and were willing
to be randomized. The sample was relatively homogeneous with

regard to race/ethnicity and socioeconomic status limiting the
generalizability of the findings. HCPs were asked to provide brief
exercise advice to patients during a follow-up visit, but we were
not able to assess whether advice was provided at subsequent
follow-up visits, which may be a confounder. Another drawback is
that the measures of PA were based on self-report. While we
included a conservative contact control group (that may have
inadvertently kept PA salient for the CC arm), there was no true
control group in the study. Finally, it is possible that additional
effects might have been detected on self-reported physical func-
tioning had the sample included women with poorer functioning at
baseline.

Strengths of the study include a large sample size of women
within 5 years of a breast cancer diagnosis, documented delivery of
HCP advice, use of several standardized measures of PA, motiva-
tional readiness and psycho-social outcomes, a theoretically based
intervention, and follow-up assessments at 6 months and 12
months. Our results show that among motivated volunteer HCPs,
providing brief advice was feasible in the context of a follow-up
visit, and when this advice was supplemented by telephone coun-
seling, patients’ PA participation increased for at least 6 months.
HCP advice is perceived as credible to patients and if the advice is
kept brief and does not take valuable time from the HCP-patient
encounter, it is not likely to be burdensome in the health care
setting. While we cannot be sure that HCP advice alone would
suffice (our study design does not allow us to draw that conclu-
sion), our results suggest that the HCP advice will require supple-
mentation to support the adoption and maintenance of PA in this
patient population. There is scope for examining whether this type
of intervention can be implemented in large health care systems
where cancer patients are monitored for follow-up care.

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J. R. (2007). Randomized controlled trial of the effects of print materials
and step pedometers on physical activity and quality of life in breast
cancer survivors. Journal of Clinical Oncology, 25, 2352–2359. doi:
25/17/2352[pii]10.1200/JCO.2006.07.9988

Ware, J. E., Jr., & Sherbourne, C. D. (1992). The MOS 36-Item Short-
Form Health Survey (SF-36). I. Conceptual framework and item selec-
tion. Medical Care, 30, 473– 483. doi:10.1097/00005650-199206000-
00002

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625PHYSICAL ACTIVITY INTERVENTION

http://dx.doi.org/24/21/3465[pii]10.1200/JCO.2006.05.7224,1532928

http://dx.doi.org/10.1016/S0738-3991%2898%2900127-X

http://dx.doi.org/10.1016/S0738-3991%2898%2900127-X

http://dx.doi.org/10.1001/archinte.168.9.979

http://dx.doi.org/S0749-3797%2807%2900010-4[pii]10.1016/j.amepre.2007.01.004

http://dx.doi.org/10.1200/JCO.2005.06.085

http://dx.doi.org/10.1007/BF02895032

http://dx.doi.org/S0749-3797%2811%2900742-2[pii]10.1016/j.amepre.2011.08.025

http://dx.doi.org/S0749-3797%2811%2900742-2[pii]10.1016/j.amepre.2011.08.025

http://dx.doi.org/10.1207/s15324796abm2802_5

http://dx.doi.org/10.1200/JCO.2005.02.148

http://dx.doi.org/10.1200/JCO.2005.02.148

http://dx.doi.org/10.1007/BF02884958

http://dx.doi.org/10.1037/0278-6133.11.6.386

http://dx.doi.org/10.1037/0278-6133.11.6.386

http://dx.doi.org/10.1007/s00520-006-0122-x

http://dx.doi.org/10.1097/00005650-199303000-00006

http://dx.doi.org/301/18/1883[pii]10.1001/jama.2009.643,2752421

http://dx.doi.org/301/18/1883[pii]10.1001/jama.2009.643,2752421

http://dx.doi.org/23/15/3577[pii]10.1200/JCO.2005.03.080

http://dx.doi.org/23/15/3577[pii]10.1200/JCO.2005.03.080

http://dx.doi.org/S0749-3797%2805%2900278-3[pii]10.1016/j.amepre.2005.06.016

http://dx.doi.org/S0749-3797%2805%2900278-3[pii]10.1016/j.amepre.2005.06.016

http://dx.doi.org/10.1037/0022-006X.51.3.390

http://dx.doi.org/10.1037/0022-006X.51.3.390

http://dx.doi.org/10.1200/JCO.2006.06.6340

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http://dx.doi.org/10.1007/s11764-009-0110-5

http://www.health.gov/paguidelines

http://www.health.gov/paguidelines

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Journal of Pain and Symptom Management, 13, 63–74. doi:10.1016/
S0885-3924(96)00274-6

Received July 27, 2011
Revision received February 28, 2012

Accepted March 9, 2012 �

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626 PINTO, PAPANDONATOS, AND GOLDSTEIN

http://dx.doi.org/10.1016/S0885-3924%2896%2900274-6

http://dx.doi.org/10.1016/S0885-3924%2896%2900274-6

• A Randomized Trial to Promote Physical Activity Among Breast Cancer Patients

Methods
Design
Recruitment
Procedure
HCP Advice
HCP Advice Plus Telephone Counseling (Intervention)
HCP Advice Plus Contact Control Group (Control)
Intervention Delivery
Measures
Seven-Day Physical Activity Recall (7-day PAR;Blair et al, 19 …
Stage of Motivational Readiness for PA (Marcus, Rossi, Selby …
MOS 36-Item Short Form Health Survey (SF-36; McHorney, Ware, …
Functional Assessment of Cancer Therapy Scale-Fatigue (FACT-F)
Analyses
Results
Sample Characteristics
PA Outcomes
Seven-day PAR
Meeting PA guidelines
Motivational readiness
Psychosocial Outcomes
Physical functioning
Fatigue
Intervention Delivery
Discussion
References

1

Clinical Problem

Social Anxiety is described by The Diagnostic and Statistical Manual of the American

Psychiatric Association (DSM-5) as a persistent fear of social situations where the person is

exposed to people or to possible scrutiny by others and fears that he/she will display

symptoms of anxiety or be perceived in a way that will be embarrassing and humiliating

(American Psychiatric Association, 2013). This topic was chosen as according to Kessler et

al. (2012) social anxiety is among the most common anxiety disorder affecting 13% of

individuals at some stage in their lives. From experience, and according to Krysta et al.

(2015) medication is the first line treatment for anxiety disorders due to accessibility.

Unfortunately, for people experiencing social anxiety most medications have adverse effects

such as increased agitation and sexual dysfunction (Rosen et al 1999) and some medication,

in particular benzodiazepines are highly addictive (Lader and Kyriacou, 2016). Townend et

al. (2008) report that CBT remains the psychological therapy with the widest and broadest

evidence base. Beck et al (1979) define Cognitive Behavioural Therapy (CBT) as a concept

where an individual’s emotions and behaviours are based on the way that they interpret the

world through their cognitions. NICE (2011) (cited in Clark, 2011) recommend psychological

therapies prior to medication for anxiety disorders however due to a lack of therapists in

mental health services this is not the case in clinical practice which led to the rationale for the

following research question.

2

Clinical question

Are psychological interventions more efficacious than pharmacological interventions to help

reduce social anxiety disorder (SAD) symptoms in adults?

Bragge (2010) explains that answerable clinical research questions have four essential

components known as PICO. This therapy type question was developed using these

components (P) Population: adults that experience social anxiety (I) Intervention:

Psychological interventions (C) Comparator: Pharmacological Interventions (O) Outcome:

reduction of social anxiety symptoms.

Search Strategy and Outcome

A systematic literature search was carried out using electronic databases which were

individually accessed via Queens Online, including MEDLINE, Science Direct, PschINFO

and Cochrane (see Appendix 1). Roberts and Dicenso (1999) suggest that questions in

relation to interventions and their effectiveness are best answered by randomized control

trials or based on the hierarchy of evidence, systematic reviews. BestBets.org was also

accessed for evidence based synopses.

The three papers the author deemed relevant to answer the clinical question above are as

follows;

Clark et al. (2003)

Nordahl et al (2016)

Davidson et al. (2004)

3

These three studies were chosen as their methodological design appeared to answer the

clinical question posed. They were critically appraised using the Critical Appraisal Skills

Programme (CASP UK, 2017) relevant tool as a foundation. Nadelson and Nadelson (2014)

teaches that the CASP tools effectively cover the areas needed to critically appraise evidence.

Initially, presumptions were made that databases would be inundated with literature on this

topic but it became apparent that limited appropriate journals were available. On reflection,

individuals with social phobia find it difficult to engage for fear of being negatively appraised

(Amir et al. 2009), and therefore would find it difficult to engage with psychiatric services

and clinical trials.

Critical appraisal

The randomized placebo-controlled trial by Clark et al. (2003) set out to compare cognitive

therapy with fluoxetine in generalized social phobia. Sixty patients aged between 18 and 60

years of age with a diagnosis of generalized social phobia as per the DSM-IV criteria were

randomly assigned to three arms; Cognitive therapy, Fluoxetine + self-exposure and placebo

+ self-exposure.

The study by Clark et al. (2003) addressed a clearly focused issue as the population studied,

the intervention given and the comparator are all presented in the main body of the article

however, the outcomes are not clearly specified. Stanley (2007) highlights that a primary

outcome will decide on the overall result of the study, adding that an RCT must have only

one primary outcome and should be clearly defined. Stratified randomisation was carried out

including two variables; gender and avoidant personality disorder and allocation concealment

followed which both decrease bias and increase validity. Stratified randomization, uses

random selection within each strata in an attempt to ensure that no bias, deliberate or

4

accidental, interferes with the representative nature of the patient sample (Altman & Bland

1999). Allocation to fluoxetine or placebo were double blinded, this is important as blinding

seeks to reduce performance and ascertainment bias after randomization (Altman & Schulz

2001). The groups appear to have been treated equally as assessments were carried out by an

independent assessor which reduces bias and therefore increases validity.

The study provides a paragraph of the patient’s characteristics and emphasises that there were

no significant differences between the arms. A table of patient characteristics and distribution

to arms would have made this clearer and limit any doubt of bias. An explanation for the

patients that dropped out was also provided, however, a CONSORT flow chart which would

show the flow of participants through each stage of the study would have made it clearer.

An intention to treat (ITT) analysis was utilised and dropouts were accounted for. ITT is a

strategy for the analysis of RCT’s that compares patients in the original groups to which they

were randomly assigned (Hollis & Campbell 1999). ITT analysis ensures true effects of a

study by accepting that noncompliance and protocol deviations are likely to occur in actual

clinical practice (Gupta, 2011). ITT analysis therefore avoids bias, as without it researchers

could selectively exclude participants from the groups they were randomized to. Clark et al.

(2003) reported that they employed a self-report measure developed by themselves which

could introduce bias and would make it difficult for other researchers to replicate this study.

Overall, the researchers of this study appear to have covered sufficient aspects to ensure

internal

validity.

The randomised clinical trial by Nordahl et al. (2016) aims to evaluate whether Paroxetine

(SSRI) is more effective than Cognitive therapy and whether a combination of the treatments

is more effective than the single interventions in the treatment of Social Anxiety Disorder

5

(SAD) with and without avoidant personality disorder (APD). 102 participants were

randomly allocated to four arms of the trial; Paroxetine, pill placebo, Cognitive therapy (CT),

and a combination of Paroxetine and CT.

The study by Nordahl et al. (2016) clearly addressed a focused issue as the population,

intervention, comparator and outcomes were clearly identified. The rating scales ADIS-IV,

SCID-II, both the primary outcomes and the secondary outcomes were rated and assessed by

independent evaluators increasing validity. However, it could be suggested that these

independent assessors were blinded also as Karanicolas et al. (2010) reports that bias can be

introduced both intentionally and unintentionally.

Similar to Clark et al. (2003) stratified randomization was carried out to ensure equal

distribution of gender and Avoidant Personality Disorder (APD) increasing validity.

According to Hidalgo et al. (2001) there is a higher incidence of SAD in women with

Eikenaes (2015) adding that there is an uncertainty whether APD and SAD are different

disorders, or are different degrees of severities of SAD. Triple masking of the patient,

psychiatrist and principle investigator was carried out for the arms receiving pills

(paroxetine/placebo), the goal of masking is to minimize potential biases (Forder et al. 2005)

which therefore increases validity of the trial. The study also informs us that 15% of the

patients were interviewed by telephone which could introduce bias as not all the patients were

treated the same. As psychiatrists and therapists were all experts in this study, allegiance bias

may have been introduced, allegiance bias in psychotherapy outcome studies refers to the

results being distorted by the investigators’ theoretical or treatment preferences (Wilson et al.

2011). Overall, the researchers appeared to cover sufficient aspects for the reader to accept its

validity.

6

The randomized double blind placebo controlled trial by Davidson et al. (2004) compared

fluoxetine (FLU), comprehensive cognitive behavioural group therapy (CCBT) , placebo

(PBO) and the combinations of CCBT/FLU and CCBT/PBO to treat generalized social

phobia over a 14 week period. 295 participants were randomized evenly into the 5 arms,

primary outcomes were measured with the Brief Social Phobia Scale and Clinical Global

Impressions scales and the secondary outcome was a videotaped behavioural assessment

using the Subjective Units of Distress Scale (SUDS).

An evaluator independent from the team was blinded and assessed both the primary outcomes

reducing bias and increasing validity. The study was carried out at two academic outpatient

psychiatric centres in Durham and Pennsylvania covering large populations.

Block randomization was carried out by a computer program which reduces bias however the

researchers admit that this was not fully adhered to as they ‘balanced CCBT groups to

include at least 2 women and 2 men’ introducing selection bias and decreasing the validity of

the study.

Compliance to medication was monitored by pill counts at each visit and reviewing daily

medication logs. The validity of the study would have been increased if blood tests had been

carried out by an independent laboratory to ensure compliance. High degrees of non-

adherence in randomized controlled trials (RCTs) can lead to failure to detect a true treatment

effect (Murali et al. 2017).

Primary outcomes measures were assessed by a blinded independent evaluator increasing

validity. Blinding of data collectors and outcome adjudicators is crucial to ensure unbiased

ascertainment of outcomes (Karanicolas et al. 2010) but the blinding process was not

evaluated which leads to doubts whether blinding was successful.

7

Internal validity is questioned in this trial as there are possibilities for bias, furthermore the

duration of the trial lasted only 14 weeks, and therefore results are to be viewed with caution.

Results:

In Clark et al. (2003) social phobia was measured on a social phobia composite which was

based on seven individual social phobia measures. There was a large effect size for Cognitive

therapy (CT) at posttreatment (1.31) and a small treatment effect for Fluoxetine and self-

exposure (0.21) based on Cohen’s (1988) (cited in Clark et al. 2003) threefold classification

of effect size. Rice (2009) teaches that the larger the effect size, the more powerful the

treatment intervention. Paired comparisons indicated that CT was superior to fluoxetine +

Self exposure and Placebo + self-exposure on the social phobia composite scale (group effect

9.5=p<.001.) and all seven individual measures at posttreatment. Surprisingly, there was no

statistical significance between Fluoxetine+ Self-exposure (effect size 0.92) and the control

Placebo+ self-exposure (effect size 0.56), post treatment.

In Nordahl’s et al. (2016) study, the primary outcome was measured by the level of

symptoms on the Fear of Negative Evaluation questionnaire (FNE). There were three

secondary outcome measures; Liebowitz Social Anxiety Scale (LSAS), the Beck Anxiety

Inventory (BAI) and the Inventory of Interpersonal Problems (IIP). This study resulted that

the combination group (Paroxetine and CT) were equal to the Paroxetine group, post

treatment (mean difference = -2.166, p=0.806) on the FNE. At the 12 month follow up there

was no difference between CT and the combination group, however both were more effective

than the placebo and Paroxetine arms. On the secondary measure the LSAS the CT group

alone performed better than any of the other 3 arms at the 12 month follow up. Of great

significance were the recovery rates 68% of the CT group compared to 45% of the

8

combination group, 23% in the paroxetine group and 4% in the placebo arm. Effect sizes

were high suggesting both clinical and statistical significance.

Davidson et al. (2004) resulted in Fluoxetine alone producing a p value of <.01 from 0-4

weeks. At the end of treatment (14 weeks) a statistical significance was established in all

arms except the placebo group on the primary outcome Brief Social Phobia Scale (BSPS) and

the secondary outcome Social Phobia and Anxiety Inventory (SPAI) indicating a p value of

<.05 and a confidence interval of 95%. However on the Clinical Global Impressions Scale

(CGI), the second primary outcome, Fluoxetine and the combination of CCBT+FLU were

superior at the end of treatment (p=.01) but no statistical difference for CCBT or CCBT/PBO.

Du Prel et al. (2009) explain that a Confidence Interval (CI) predicts the precision of the

results. If the CI is wide, the estimate of true effect lacks precision and therefore doubts the

treatment effect. If the confidence interval is narrow, precision is high, and we can be more

confident in the results. There was no statistical difference between combined therapies and

monotherapies.

Clinical Bottom line

Based on the evidence from the above three studies, psychological therapy, in particular a

form of CBT, and pharmacological therapy, in particular, a SSRI, are both effective at

reducing symptoms of SAD, however, Cognitive Therapy was superior in the long term in

two out of three of the studies. Interestingly, there was no evidence found that a combination

of both interventions were more effective than their monotherapies on recovery rates.

9

Applicability to Practice

In order for a trial to be clinically useful the results must also be relevant to a definable group

of people in a clinical setting, this is known as external validity/applicability (Rothwell 2005).

It is not stated where Clark et al. (2003) trial was carried out, Davidson et al. (2004) study

was based in North Carolina and Philadelphia and the RCT by Nordahl et al. (2016) was

carried out in Norway. The aforementioned increases external validity as results are

applicable to the various nationalities in the local population. All three studies utilised the

DSM and the majority of the outcome measures are utilised in current practice indicating that

the results can be applied to the local population.

Clark et al (2003) and Nordahl et al. (2014) both had small sample sizes assessing

approximately 20 participants per treatment group at post treatment assessments reducing

applicability, as Everitt and Wessely (2004) report that a large sample size is more

representative of the population and minimises random error.

The inclusion and exclusion criteria are well defined for all three studies, participants were

both male and female with a primary diagnosis of social anxiety disorder with Clark et al.

(2004) and Nordahl et al. (2016) both including avoidant personality disorder but excluding

depression. This could limit the generalisability of these results as the majority of the patients

that come in contact with the mental health services in Ireland present with comorbid

psychiatric problems such as depression. This is supported by Magee et al. (1996) who report

that 81% of people that experience social anxiety disorder reported experiencing another

disorder with Katzelnick et al. (2001) adding that up to 35% of sufferers of SAD experience

major depression with SAD preceding depression up to 12 years.

10

Despite these results, the majority of patients in the local area being treated for social anxiety

are receiving some form of anti-depressants as the waitlist for CBT is 3 months or more with

Magee et al. (1996) adding that people with social anxiety do not regard themselves as

suffering from an anxiety disorder, but shy, and do not seek help until comorbid disorders

such as depression, affect them.

Implementation

Whilst researching for this critically appraised topic it became apparent the lack of RCT’s

and therefore, systematic reviews, that compare psychological and pharmacological

interventions for SAD. The Cochrane Journal club was suggested by the hospital librarian,

this club is aimed at healthcare professionals and covers a single review of special interest,

selected from the new and updated reviews published in the Cochrane Library. Lawrie et al

(2003) also suggests that mental health professionals establish a local evidence-based

psychiatry journal club (EBPJC) which would develop critical appraisal techniques and

encourage the implementation of evidence based practice.

Grol and Grimshaw (2003) reported that one of the most consistent findings in health services

research is the gap between evidence based practice (EBP) and actual clinical care. Grol and

Wensing (2004) reports that studies in countries such as the United States and the

Netherlands suggest that up to 40% of patients do not receive care according to current

scientific evidence, while 20% or more of the care provided is not needed or potentially

harmful to patients.

In a study carried out by Melnyk et al. (2012) on nurses in the United States, the two most

frequently cited barriers to EBP, were a lack of time and a workplace resistance, mostly from

11

management, to change. This study proposes that EBP mentors work alongside clinicians to

facilitate learning these skills and implement them into practice consistently. Facilitation is

considered necessary for enabling successful implementation and is described by Rycroft-

Malone, (2004) as the process of supporting the implementation of evidence into practice and

support to aid nurses alter their attitudes and ways of working.

Organizations need to consider resources required for EBP as a lack of resources are

unfavorable to the success of implementation (Dogherty et al, 2013), financial, personnel,

equipment, support, access to evidence, and time are all forms of resources. From experience

as a mental health nurse, lack of time to access library facilities and lack of

motivation/support to implement new practice are the main restraining factors for frontline

staff. Thompson et al. (2008) supports this by pointing out that busyness, in the context of

research utilization, includes multiple dimensions such as physical time, but perhaps more

importantly, mental time.

It is evident in practice that mental health nurses are not familiar with CBT techniques or the

benefits despite many years of experience as mental health nurses. Most educational

institutions in Ireland do not provide basic psychological therapy training to mental health

students, however, there is an emphasis placed on pharmacology. It is important that

organizations examine existing resources that could be utilized to promote change, that is,

facilitate nurses to attend training days, encouragement of research, time allocated for

research and encourage staff to return to education on a part time basis by providing

incentives such as; funding, study days and instill hope of post progression/promotion

following their studies.

Lewin’s (1951) (cited in Bowers 2011) proposed a three-step process to change management

which offers a structured approach to understanding and changing behaviour in the workplace.

http://onlinelibrary.wiley.com/doi/10.1111/wvn.12009/full#wvn12009-bib-0023

http://journals.rcni.com.queens.ezp1.qub.ac.uk/doi/full/10.7748/ns.30.1.38.e9296

12

It relates well to healthcare practice, as its three stages of ‘unfreezing’, ‘moving’ and

‘refreezing’ are similar to the healthcare processes of ‘planning’, ‘implementing’ and

‘evaluating’ care. This process is outlined with the clinical bottom line of this critical

appraisal in mind and focusing on the psychological therapy, CBT.

Unfreezing/Planning: Approaching management with the findings of this appraisal that

psychological therapies are more beneficial than pharmacological therapies and the most cost

effective therapy for health services (Mavranezouli 2015). A proposal would be presented to

hold workshops to educate mental health colleagues on the evidence based benefits of CBT

and the basic techniques of CBT. Gage (2013) emphasize that support must be gained from

senior management who have an appropriate area of responsibility, and who would benefit

from this service improvement idea and support the implementation of the project.

Moving/Implementing: Nursing staff acquire basic CBT skills and implement them into daily

practice. Gage (2013) reports that if staff are involved in change from the early stages they

are more likely to feel more invested in assisting with the delivery of the change plan, with

Hall and Hord (2011) adding staff are more likely to accept change than if it is not imposed

on them ‘from above’.

Refreezing/ evaluation: Staff to monitor for a decrease in symptoms of SAD. Parkes and

O’Dell (2015) report that if changes are implemented it is imperative that these changes are

audited to ensure the continued provision of quality care.

If the above implementation plan was a success, Mental Health Nurses could then practice

basic CBT techniques with patients while they await an appointment from a qualified

therapist. As a result, patients would then know what to expect from therapy, attend their

appointment and limit the chance of deterioration. In addition, it may encourage nursing staff

to return to higher education to train as Cognitive Behavioural Psychotherapists.

13

Appendix 1: Search Strategies

Search on Medline: After using additional keywords and filters my search finally resulted in 1 text

being retrieved Clark et al (2003) and deemed as appropriate for critical appraisal following the

reading of each abstract. Filters used were: full text, published in peer review journals and that the

keywords would be in the title of the text.

SEARCH MEDLINE: Key Words and Boolean Operator

HITS

S1 Social Phobia 3410

S2 Cognitive therapy 21864

S3 Fluoxetine 11846

S4 1 AND 2 AND 3 17

Search on PsycINFO: The key words used were CBT, anxiety and depression. The Boolean operator

AND was used. Filters were: journals, full text and that the keywords would be in the title of the text.

Following inspection of the abstracts one was chosen for critical appraisal (Nordahl et al. 2016)

SEARCH PsycInfo

Key Words and Boolean Operator

HITS

S1 Social Anxiety Disorder 4078

S2 Cognitive therapy 6863

S3 Paroxetine 958

S4 1 AND 2 AND 3 2

14

Search on Science Direct: Filters were: journals, full text, keywords would be in the title of the text

and year limit from 2014-2017 to locate the most recent evidence. Following inspection of the

abstracts none was deemed appropriate for critical appraisal

SEARCH ScienceDirect

Key Words and Boolean Operator
HITS

S1 Social Phobia 2444

S2 AND psychological and Pharmacological

Interventions

331

Search on Cochrane: Following inspection of the abstracts one was chosen for critical appraisal

(Davidson et al. 2004).

SEARCH Cochrane

Key Words and Boolean Operator
HITS

S1 Social Phobia 1120

S2 AND Fluoxetine 33

15

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BMJ 318: pp.1209.

2. Altman D.G. and Schulz, K.F. (2001) ‘Statistics notes: Concealing treatment allocation in

randomised trials’ British Medical Journal 323, pp. 446–447.

3. American Psychiatric Association. (2013). Diagnostic and Statistical Manual of Mental

Disorders: DSM-IV-TR. Washington, DC: American Psychiatric Association.

4. Amir, N., Beard, C., Taylor, C. T., Klumpp, H., Elias, J., Burns, M., & Chen, X. (2009).

‘Attention Training in Individuals with Generalized Social Phobia: A Randomized Controlled

Trial’, Journal of Consulting and Clinical Psychology, 77(5), pp. 961–973.

5. Beck A.T., Rush A.J., Shaw B.F. & Emery, G. (1979) Cognitive Therapy of Depression. New

York: Guilford Press

6. Bowers, B. (2011) ‘Managing change by empowering staff’, Nursing Times, 107(32-33) pp.

19-21.

7. Bragge, P. (2010), ‘Asking good clinical research questions and choosing the right study

design’, Injury, 41(1), pp. 3-6.

8. Canton J, Scott K.M.,& Glue, P. (2012) ‘Optimal treatment of social phobia: systematic

review and meta-analysis’. Neuropsychiatric Disease and Treatment, 8: pp. 203-215.

9. Critical Appraisal Skills Programme (2017). CASP Randomised Controlled Trial Checklist.

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