Peers Promoting Exercise Adoption and Maintenance Among Cancer Survivors
Phase: NA
Conditions: Breast Cancer
Sponsor: University of South Carolina

 
 
 
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Peers Promoting Exercise Adoption and Maintenance among Cancer Survivors  
NCT: 02694640 
Date: March 30, 2020 
 

 
 
 
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Objectives / Research Aims 
Regular exercise has been recommended by the American College of Sports Medicine for 
cancer patients and survivors (Schmitz et al., 2010). The recommendations are based on many 
efficacy trials that have been conducted, chiefly in research settings and delivered/supervised 
by research staff.  Extending the reach of interventions by training community peer volunteers to 
deliver the intervention makes exercise interventions much more accessible to survivors.  Such 
interventions delivered by community peer volunteers may be relatively inexpensive and may 
appeal to survivors who would otherwise not seek help. However, such efforts should be 
effective and have the potential to be easily implemented.  Our NIH-funded collaborative 
research has demonstrated that peer volunteers with the American Cancer Society’ (ACS) 
Reach to Recovery program (a peer-based support program for breast cancer patients) can be 
trained to deliver a 3-month home-based exercise program to breast cancer patients and the 
program has been shown to be effective in increasing exercise participation in the short-term 
(<6 months).  But, the effects of the program while continuing to be significant were attenuated 
at 6 months (compared to the contact control arm).  Exercise maintenance is crucial to 
sustaining the benefits of exercise (fatigue, physical functioning and quality of life) and also to 
improve survival.  Hence, before the program can be implemented in community-based 
organizations that provide peer mentoring, the maintenance of exercise needs to be addressed.  
To do so, we propose to develop and test interventions for exercise maintenance (after the 3-
month peer counseling for exercise has ended) that can be implemented by a community-based 
organization, but which vary in mode of delivery (phone vs. email/text), live interaction with the 
peer mentor (phone), and potentially, cost effectiveness. The specific aims of this randomized 
controlled trial are: 
Primary Aim 
1. To determine the effects of Reach to Recovery (RTR) volunteers (“exercise coaches”) at 
American Cancer Society (ACS) offices providing theory-based exercise counseling via 
telephone over 3 months followed by: a) exercise logs and feedback reports during 
Months 4-9 (Reach Plus), b) monthly phone calls from coaches, activity logs and 
feedback reports during Months 4-9 (Reach Plus Phone) and c) monthly email/text 
messages, activity logs and feedback reports during Months 4-9 (Reach Plus 
Messages).  One hundred and fifty participants will be enrolled in the study. The primary 
outcome is the change in exercise at 12 months.  Our hypothesis is that Reach Plus Phone 
and Reach Plus Messages participants will report higher moderate-to-vigorous physical 
activity (MVPA) compared to Reach Plus participants at 9 and 12 months, and that there will 
be no difference in MVPA in Reach Plus Phone compared to Reach Plus Messages at these 
time-points.  We do not anticipate significant group differences at 3 months.  
Secondary Aims 
2. To examine the costs related to developing and implementing the interventions (e.g., time 
spent in training, and supervising the RTR coaches, time involved in intervention 
development and delivery), costs to the participants and the cost-effectiveness of each 
intervention. We hypothesize that the Reach Plus Phone and Reach Plus Messages 
interventions will have higher value compared to the Reach Plus intervention based on 
quality of life (QOL) and exercise participation. 
3. To obtain data on the intervention effects on participants’ fatigue, QOL, physical 
functioning and mood at 3, 9, and 12 months.  We hypothesize that Reach Plus Phone and 
Reach Plus Messages groups will report improvements on these outcomes at 9 and 12 
months compared to Reach Plus participants but there will be no significant group 
differences at 3 months.  
4.  To examine intervention side-effects (e.g., muscle sprains, injuries) that may occur during 

 
 
 
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study participation. 
 
Exploratory Aim 
5. To examine potential moderators of intervention effects (e.g., age, stage of motivational 
readiness) and mediators of maintenance of exercise (barriers to exercise, self-efficacy for 
exercise and social support for exercise) at 9 and 12 months. 
 
A. Research Strategy 
A.1. Significance. Improved detection rates and treatments for some forms of cancer have led 
to significantly improved cancer survival rates over the past half-century.  Five-year survival 
rates for female breast cancer have increased from 63% in the 1960s to 90%.1 There are over 
13.7 million U.S. cancer survivors and, 2.7 million of this group are survivors of breast cancer.1  
Late effects of female breast cancer include poorer physical functioning, arm lymphedema, 
premature menopause and related infertility and osteoporosis, weight gain, increased 
cardiovascular risk, fatigue, cognitive impairment, in addition, to risk of cancer recurrence and 
second primary cancers.2-4 There is a large body of evidence on the benefits of aerobic exercise 
participation to alleviate sequelae of cancer treatments when conducted with on-site 
supervision, as well as home-based programs.5-9  These data led to the 2010 American College 
of Sports Medicine guidelines for exercise for cancer survivors.10 Similar recommendations have 
been made by the American Cancer Society (ACS).11  
With the growing evidence of the role that exercise can play in cancer recovery, it is 
timely to extend the research findings into the “real world” by training community volunteers to 
encourage survivors to adopt exercise.  Our team has been one of the first in disseminating 
research efforts into the community setting.  We chose to test the potential for dissemination in 
the ACS, a not-for-profit community-based organization (CBO) that offers services to breast 
cancer patients.  Specifically, ACS’ Reach to Recovery (RTR) volunteers provide emotional 
support and information to cancer patients. Hence, it is a “natural fit” to test the effects of 
volunteers encouraging sedentary survivors to not only become more physically active to 
enhance their recovery (our randomized trial controlled trial [RCT] described in Preliminary 
Studies, B.2., showed that the CBO-based intervention was effective, particularly at 3 months), 
but also to maintain their activity to achieve lasting benefits.  
 
A.2. Peer Mentoring for Exercise Promotion. Socio-cultural and communication theories 
suggest that people are more receptive to assistance when it is delivered by someone 
perceived as similar to oneself (e.g., of comparable age and life experiences).12,13 Peer support 
for health is used to maximize impact, sustain and scale up successful interventions while facing 
limited resources and contextual constraints. Peer mentoring may be more appealing to patients 
who would otherwise not seek support. Such evidence-based approaches have been examined 
in chronic disease management (e.g., HIV, mental illness, and diabetes).14,15 
There is small but growing evidence on the effects of peer mentors to promote exercise. 
Quasi-experimental studies support the use of trained peer volunteers providing advice by 
telephone to middle-aged and older adults.16,17  In a RCT of 12 volunteer peer mentors and 181 
inactive adults aged 50 years and older, researchers compared telephone-based advice 
delivered by research staff to telephone-based advice delivered by trained volunteers and to an 
attention control arm of telephone advice for nutrition.18  Both intervention arms significantly 
increased their exercise relative to the control group at 12 months, but the peer volunteers 
showed superior quality in intervention content compared to the research staff.  In another RCT, 
81 sedentary adults received peer-delivered, theory-based support for exercise in a 16-week 
group-based program vs. a community-based intervention with health education.19  At 16 
weeks, both groups showed similar significant improvements in moderate-to-vigorous exercise 

 
 
 
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but at 18 months, the peer support group reported significantly greater exercise participation. 
These data indicate peer mentoring for exercise promotion is effective but such efforts have not 
been examined among cancer survivors.  
 
A.3. Theoretical Bases for the 3-month Peer-led Intervention. The telephone counseling 
component of the proposed exercise intervention will be based on the Transtheoretical Model 
(TTM)20,21 and Social Cognitive Theory (SCT) of behavior change that have been applied to 
exercise behavior.  We used this model successfully in home-based exercise interventions 
among breast cancer survivors,22 among patients with arterial claudication23 and among older 
primary-care patients.24,25   Reviews and a meta-analysis of the TTM have drawn largely 
positive conclusions supporting the suitability of the model to understand and promote 
exercise.26,27  The TTM model integrates current behavioral status (relating to a performance 
standard considered healthy) with a person's intention to maintain or change behavior.  Five 
stages of change (motivational readiness) are hypothesized: precontemplation (not thinking 
about making a change), contemplation (thinking about exercising or other behavior), 
preparation (engaging in behavior change below recommended levels), action (engaged in 
behavior change at recommended levels for <6 months) and maintenance (sustained behavior 
change at recommended levels for >6 months). TTM-based interventions designed to meet the 
needs of individuals at each stage are effective in promoting exercise.28,29 Key constructs from 
the TTM (motivational readiness) and from SCT (self-efficacy, and beliefs about the importance 
of exercise in reducing the risk of chronic disease, improve fatigue etc.) underlie the telephone 
counseling that the exercise coaches will be asked to deliver over 3 months. This will be 
followed by strategies to enhance exercise maintenance during Months 4-9 using constructs 
from SCT (self-efficacy) and relapse prevention.30  
 
A. 4. Exercise Maintenance. There have been >75 exercise intervention trials for various 
cancer survivor groups.9 These trials provided the evidence underlying the ACSM exercise 
guidelines for cancer survivors.10  One of the limitations of this body of literature is that while 
there is a growing support for some of the benefits of exercise adoption, less is known about the 
maintenance of exercise and the implications for the benefits (improved fitness, higher quality of 
life [QOL], reduced fatigue, etc.).  Exercise maintenance is critical to the management of 
cardiovascular disease, diabetes and other chronic diseases among cancer survivors as well as 
potentially for cancer survival.31-34 We have found that the psychosocial benefits of exercise for 
cancer patients did not sustain if the behavior is not maintained for at least 6 months.35  
Maintenance of outcomes is also fundamental to inform the translation of evidence-based 
behavior interventions into practice.36   
Maintenance has been defined as a follow up evaluation of a behavioral outcome 
occurring at least 3 months postintervention contact.37 A review of 29 trials that targeted either 
exercise alone, diet only or both exercise and diet found that 72% of the studies achieved 
maintenance of behavior change.37 The authors reported that maintenance was associated with 
sample characteristics (studies targeting women were less likely to achieve maintenance), study 
method (trials with higher retention showed higher maintenance) and intervention features such 
as intervention duration (>6 months), face-to-face contact, use of more intervention strategies 
and the use of follow-up prompts. A recent review of exercise and/or dietary interventions in 
breast cancer survivors, found that only 10 trials assessed post-intervention maintenance of 
outcomes, and only four trials achieved successful maintenance of behavior change for at least 
50% of outcomes.38  This review suggested that extending program contact with participants 
may promote maintenance but no conclusions could be reached as to the most effective 
maintenance strategy. To date, there is limited evidence to suggest which strategies support 
exercise maintenance in chronically ill39  and healthy populations40 and whether these differ 
from those known to support exercise initiation.  

 
 
 
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Given our partnership with the RTR program within the ACS, we have selected to 
compare maintenance strategies (behavioral component of self-monitoring, follow-up email/text 
messages to remind and motivate, and continued contact with the peer volunteers) that are 
based on the literature and are likely to be feasible for implementation by CBOs. We considered 
the use of other technologies such as smartphones but chose email/text for one intervention 
group because the latter is simple, widely used by the ACS, likely to have a wide reach, and can 
be disseminated in not-for-profit CBOs. The total intervention duration will be for 9 months 
(Months 1-3: Exercise Adoption, Months 4-9: Exercise Maintenance).  We will also explore 
potential moderators of exercise maintenance (age, motivational readiness, stage of disease) to 
address questions such as who benefits from which maintenance strategy and mediators of 
intervention effects (e.g., self-efficacy). 
 
A. 5. Reach to Recovery (RTR) Program.  For over 35 years, the RTR program has helped 
people cope with breast cancer.  RTR volunteers, who are breast cancer survivors themselves, 
give support for those with a new diagnosis, breast cancer recurrence or metastasis. The 
volunteers offer understanding, support and hope because they themselves have survived 
breast cancer and have gone on to live productive lives.  Volunteers are carefully selected, 
complete initial training, and participate in ongoing continuing education sessions. There are 
>13,000 volunteers with the RTR program: it is now the largest peer one-on-one program 
offered by the ACS.  Hence, if the results of this RCT are promising, the intervention for 
exercise adoption and maintenance can be integrated into the current services offered by the 
RTR program and tested in ACS offices (or other cancer care CBOs that offer peer support) in 
other states in a larger, dissemination trial.  
 
B. Preliminary Studies 
 
 Dr. Pinto (Principal Investigator, P.I.) has developed programmatic research on exercise 
promotion to enhance recovery among cancer survivors over the past 20 years. She has 
developed and demonstrated the efficacy of home-based exercise programs among 
breast22,41,42 and colorectal cancer survivors.43 The following studies have been selected to 
document the team’s ability to conduct the trial and to describe the groundwork for the scientific 
and practical viability of the proposed study.  
 
B.1. Exercise Intervention Delivered by American Cancer Society’s Reach to Recovery 
Volunteers.  We recruited Reach to Recovery (RTR) volunteers with the American Cancer 
Society to offer our effective telephone-delivered home-based exercise program22 to 25 breast 
cancer survivors (study funded by the Lance Armstrong Foundation).42  The program based on 
the TTM of Behavior Change and Social Cognitive Theory was offered over 3 months and 
outcomes were assessed at 3 and 6 months.  Seven RTR volunteers were recruited as exercise 
coaches (mean age = 59.6 years; mean number of years volunteering with RTR = 7 years). 
Coaches received 10-12 hours of training and were asked to contact their participants weekly 
for 3 months (12 weeks=12 calls) and audio-tape their telephone contacts. The research team 
reviewed the audio-tapes and provided bi-weekly supervision of the coaches via phone.  
Research staff conducted the participants’ assessments at baseline, 3 and 6 months.  Results:  
Using t- tests to examine changes from baseline, we found that participants significantly 
increased moderate-to-vigorous physical activity (MVPA as assessed by the 7 Day Physical 
Activity Recall) from baseline to 3 months (p<.0001) and from baseline to 6 months (p<.01).  
Effect sizes were large (∆=0.99 at 3 months) to moderate (∆= 0.62 at 6 months).  For the 
psycho-social outcomes, significant reductions in the effects of fatigue were reported both at 3 
months (p<.0001) and 6 months (p<.001) compared to baseline.  The effect sizes were large at 
both time-points (∆=0.78 and ∆=0.89 respectively).  Mood (assessed by the Profile of Mood 

 
 
 
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Scale, Total Mood Disturbance score) did not show changes at 3 months but there were 
significant improvements at 6 months (p<.01) (effect size was moderate, ∆=0.69).  Feasibility 
and Acceptability of the Intervention. Coaches’ perspective:  RTR coaches were able to deliver 
93% of expected calls; the mean number of calls across participants was 10.72 (maximum 
number of calls was 12; SD=2.5) with a mean duration of 15.22 minutes (SD=6.11).  All the 
coaches recommended the program to future participants.  Participant evaluations: At 3 months, 
participants (n=22) also rated the program very favorably with a mean rating=4.8, SD=0.5 (1-5 
rating scales, 1=Low, 5=High).  91% judged the weekly calls to be the appropriate length and 
96% judged the number of calls to be about right.  91% reported that they would recommend 
the program to others.  In sum, we obtained preliminary data on the intervention effects, tracked 
side-effects of study participation and obtained feedback from the participants.  In addition, we 
refined the training materials and procedures to make them appropriate and feasible for 
coaches, refined our supervision of intervention delivery, and obtained data on the feasibility of 
volunteers’ offering the intervention.42  
B.2. Randomized Trial of Exercise Counseling Delivered by American Cancer Society’s Reach 
to Recovery Volunteers. Based on our pilot work (Preliminary Studies, B.1), in an on-going 
study (R01 CA132854), we trained 18 RTR volunteers in six states to deliver the 3-month 
exercise counseling to 76 breast cancer patients (B. Pinto, P.I, K. Stein, S. Dunsiger, Co-Is).  
We compared the effects of exercise counseling delivered by telephone by RTR coaches 
(Reach Plus) vs. a contact control condition (Reach Standard) in 6 New England states.  The 
coaches (n=18; mean age=54.9 years, mean years with the RTR program=4.2) delivered the 3-
month exercise program to help participants adopt 30 minutes of MVPA on >5 days/week. 
Breast cancer survivors (n=76; mean age=55.6 years, mean years since diagnosis=1.1 years) 
were randomized to Reach Plus or Reach Standard. At pretreatment, posttreatment (3 months) 
and 6 months, participants completed the 7 Day Physical Activity Recall, wore an accelerometer 
and completed measures of fatigue (FACT-F) and QOL (FACT-B). Mixed effect longitudinal 
regression models for between group differences at 3 and 6 months, while controlling for age 
and chemotherapy showed significant effects for MVPA in Reach Plus at 3 months (adjusted 
mean difference = 102.95 minutes/week of MVPA, t=6.6,p<.0001) and at 6 months (adjusted 
mean difference = 34.7 minutes/week of MVPA, t = 2.23, p=.02).  Effects on self-reported 
exercise were confirmed with similar analyses on accelerometer data on MVPA at 3 months 
(adjusted treatment difference of 48.5 minutes/week, t = 4.08, p<.0001) and at 6 months 
(treatment difference of 38.7 minutes/week, t = 3.22, p<.01).44  Data analyses of secondary 
outcomes are on-going.  There were no serious adverse events related to exercise. Coaches 
delivered 92.98% of expected calls; mean number of calls across participants was 11.16 (max. 
number of calls was 12; SD=2.24) with a mean duration of 18.46 minutes (SD=7.36). All the 
coaches recommended the program to future participants (100%). This study demonstrates our 
ability to train peer volunteers (exercise coaches) in several states to provide exercise 
counseling using both in-person training and videoconferencing, supervise exercise coaches, 
collect data from patients who received the exercise counseling and assess effects of the 
exercise counseling on patients’ exercise participation, the primary outcome in the proposed 
work.  However, while it is clear that the intervention when offered by peer coaches facilitated 
exercise adoption, the effects on exercise maintenance (6 months) were not as strong. Hence, 
in the current proposal, we will implement and test strategies for exercise maintenance before 
dissemination to RTR programs in other states or other cancer care organizations. Our goals 
are to obtain data that peer volunteers can help breast cancer survivors adopt and maintain 
exercise by testing the effects of evidence-based maintenance strategies in a community 
setting. 
 

 
 
 
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C. Setting 
As described, the coaches who participate in the study will be recruited chiefly by the American 
Cancer Society through mailing lists that they maintain.  Training of coaches will be done via 
video-conferencing or at ACS offices. Study assessments will be conducted with the coaches 
via mailed questionnaires and telephone.  Study participants will be recruited with the help of 
the American Cancer Society, Palmetto Health, South Carolina Oncology Associates. All study 
assessments will be done via mail and the exercise interventions will be delivered by telephone 
and by mail.  
D. Study Design 
This is a randomized controlled trial where 150 breast cancer survivors will be randomized to 
one of 3 intervention groups: Reach Plus, Reach Plus Phone and Reach Plus Message. 
Participants will complete assessments of MVPA and psychosocial variables at baseline, 3, 6, 9 
and 12 months. The unit of randomization will be at the patient level. Intervention delivery will 
end in Month 9.  
 
D.1. Recruitment Methods 
ACS RTR Volunteers. An orientation to the study and procedures will be conducted at each 
collaborating ACS office as we have done previously (Preliminary Studies, B.2).  Currently there 
are 1690 RTR active volunteers in the South Atlantic Division, and there are 765 RTR 
volunteers at the ACS offices in GA and NC that will collaborate on this trial.  We will recruit 10-
12 volunteers from this group to be trained as “coaches.” Each coach is expected to work with 
15-18 participants over the study duration. Dr. Kevin Stein (Managing Director of Behavioral 
Research at the ACS National Office that oversees the RTR programs) and Ms. Shanna Lee 
(Director, Mission Delivery, South Atlantic Division) have provided us letters of collaboration; 
they will assist us in recruiting volunteers to serve as coaches and to identify breast cancer 
patients on ACS constituent mailing lists who may be eligible for study participation. As in our 
prior work (Preliminary Studies, B.1. and B2), we will mail informational letters to RTR 
volunteers offering them the opportunity to be “coaches.” These letters will include testimonials 
from the coaches in our prior collaborations. Rolling enrollment and training will be offered.  
 
Due to the changes within the American Cancer Society’s organizational structure and the RTR 
program, there is a need to recruit additional coaches using alternative methods. Volunteers 
who are breast cancer survivors will be invited to be trained as coaches.  RTR training will be 
provided to volunteers as part of the study’s training plan. The American Cancer Society has 
agreed to allow interested volunteers to be trained using their online training RTR modules. We 
will send an informational flyer to previous study participants and others who have expressed 
interest in participating in the study but were too active to do so. Upon completion of the RTR 
training, all training methods for interested coaches will proceed as we have done previously.  
  
Patient Population/Participant Recruitment. ACS offices will be asked to send informational 
mailings to their breast cancer constituents lists in GA and NC (current listing, n=6980).  In 
addition, if necessary, we can recruit from mailings sent to breast cancer constituents in MD 
(n=1467). The South Atlantic Division has 14,183 cancer survivors within 5 years of diagnosis 
on their mailing lists.  We will also recruit from private oncology practices in SC (e.g., South 
Carolina Oncology Associates that have provided referrals to cancer survivorship studies 
conducted by the College of Nursing).  Patients will be provided brief information about the 
study and will be asked if they wish to participate. Interested participants will be asked to view 
an introduction to the study video and complete online pre-screening questions on the study’s 
webpage prior to contacting the study team. The study’s participant recruitment brochure and 
cover letter will be revised to include instructions for accessing the video and pre-screener 

 
 
 
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questions. Those who are preliminarily eligible will be contacted by study staff to complete the 
full telephone screen for eligibility. The study’s Project Coordinator I will explain the study to 
them and obtain verbal informed consent to conduct a telephone screen for eligibility. If eligible 
on the phone screen, the Project Coordinator I will send the participant an informed consent 
document in the mail, along with a physician consent form for the patient’s participation in the 
study. The informed consent will also be offered electronically via a link being sent to the 
participant for review and completion. The research staff will receive a notification when the 
informed consent has been completed. Research staff will re-contact potential participants in 
two weeks, if the signed consents are not received, to prompt and respond to any questions that 
may arise.  After the consent forms are obtained, participants will be mailed a packet of 
questionnaires and an Actigraph (an accelerometer to monitor exercise) with instructions and 
envelopes for returning the questionnaires and Actigraph.  In addition to mail, the baseline 
assessment will also be offered electronically via a link being sent to the participant for 
completion. The research staff will receive a notification when the baseline assessment has 
been completed. After the completed forms and Actigraph are received, the Project Coordinator 
I will contact the participant to conduct a physical activity interview (7 Day PAR, described in 
Outcomes section).  After the baseline assessments are completed, the participant will be 
randomized to one of the three study groups.  
 
Records show that approximately 8447 breast cancer patients (<5 years post-diagnosis) on the 
ACS mailing lists for GA,NC and MD (ACS South Atlantic Division, 2014).  Our target population 
is breast cancer survivors who are not already exercising. In our previous trial where we used 
similar inclusion/exclusion criteria (Preliminary Studies, B.2),13% of those screened were 
eligible and enrolled in the study (a major reason for ineligibility was women reported already 
exercising and for non-participation, the major reason was unwillingness to be assigned to the 
control group which did not receive an exercise intervention). Using these data, we estimate that 
2365 patients will be screened for eligibility and 307 (13%) of those screened will be eligible and 
enroll in the study. If necessary, we can also extend participant recruitment to the remaining 
South Atlantic states (SC, VA, WV, and DE), where there are 5736 breast cancer patients on 
the ACS mailing lists.  Using the same estimates, 1696 patients will be screened, 209 patients 
should be eligible and enroll in the study (total number of eligible patients who will enroll= 
307+209=516).  In the proposed study, all study groups will receive an exercise intervention, 
and we expect that this will enhance recruitment and generalizability of results to the population 
of survivors who do not exercise. Hence, we fully anticipate enrolling 150 women over 2 1/2 
years from the sample of 516 eligible patients who would be willing to participate in the study.  
 
D.2. Sample Randomization. Each participant will be asked to obtain medical consent from her 
oncologist to enroll as we have done successfully in prior work (Preliminary Studies B.1-B2). 
Providers will be allowed to exclude patients if the goal of moderate-intensity exercise would be 
unsafe for the patient. Randomization will occur after informed consent and baseline data are 
obtained. The sample will be stratified for two variables that may affect exercise outcomes 
(age:<60 years/>60 years; and treatment: received/not received chemotherapy).  After baseline 
assessments, the Project Coordinator II will contact the participant and disclose group 
assignment from a code number found in a sealed envelope.  We will use block randomization 
with varying block size at each collaborating ACS office, so that equal numbers of participants 
are randomized to Reach Plus, Reach Plus Phone and Reach Plus Messages at each site.  
After a participant has been randomized, the Project Coordinator II will determine coach 
assignment based on similarity of age, type of cancer treatment and availability for calls at the 
times preferred by the participant.  Each coach will be instructed to call her participant once a 
week over 3 months (12 weeks=12 calls) at a mutually convenient time.   
 

 
 
 
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Participants will receive $25 for completing the assessments at each time-point ($25 X 5=$125). 
In addition, they can receive $25 for completing 80% of exercise logs. 
Coaches will be provided small incentives such as $25 gift cards at various points in the study 
(e.g., after working with their first study participant, at the end of the year). 
 
D.3. Inclusion and Exclusion Criteria 
Eligibility Criteria for RTR coaches includes: 1) completed RTR training and has been with RTR 
for at least a year, 2) willing to participate in group training scheduled at a mutually convenient 
time, 3) willing to audio-tape contacts with participants for quality control, 4) willing to be 
supervised via phone and 5) currently exercise for at least 60 minutes/week.  Coaches will be 
asked to complete brief questionnaires before training, at the end of training and at the end of 
study participation.  
 
Eligibility Criteria for Participants. Women aged >21 years will be eligible if they: 1) have been 
diagnosed in the past five years with Stage 0-3 breast cancer (patients on radiation or 
chemotherapy will be eligible as will patients receiving hormone therapy: physician consent for 
all study participants will be obtained), 2) are able to read and speak English, 3) are ambulatory, 
4) are sedentary (i.e., <30 minutes/week of vigorous exercise or <90 minutes/week of moderate-
intensity exercise for the past six months), 5) are able to walk unassisted, and 6) have access to 
a telephone.  Women with more advanced disease (Stage 4), medical or psychiatric problems 
(e.g., substance abuse, coronary artery disease, peripheral vascular disease, diabetes, and 
orthopedic problems) that may interfere with protocol adherence will not be included. These 
inclusion/exclusion criteria are similar to those used in our prior work (Preliminary Studies, B.1. 
and B.2). Participants will be asked to provide consent for medical chart review to extract 
disease and treatment history. 
 
D.4.Study Endpoints 
Primary Endpoint 
The primary outcome is the change in exercise at 12 months.  Our hypothesis is that Reach 
Plus Phone and Reach Plus Messages participants will report higher moderate-to-vigorous 
physical activity (MVPA) compared to Reach Plus participants at 9 and 12 months, and that 
there will be no difference in MVPA in Reach Plus Phone compared to Reach Plus Messages at 
these time-points.  We do not anticipate significant group differences at 3 months.  
 
Secondary Endpoints 
Costs related to developing and implementing the interventions (e.g., time spent in training, and 
supervising the RTR coaches, time involved in intervention development and delivery), costs to 
the participants and the cost-effectiveness of each intervention.  
 
Intervention effects on participants’ fatigue, QOL, physical functioning and mood at 3, 9, and 12 
months.  We hypothesize that Reach Plus Phone and Reach Plus Messages groups will report 
improvements in these outcomes at 9 and 12 months compared to Reach Plus participants but 
there will be no significant group differences at 3 months.  
 
D.5. Procedures 
Intervention Conditions. All three study groups will be structurally equivalent with respect to 
the 3-month exercise intervention (12-weekly calls from RTR coaches, exercise logs, pedometer 
and feedback reports).  
Reach Plus.  In Months 1-3, participants in this group will be receive the previously tested 
telephone counseling for exercise22 (Preliminary Studies, B.1., B2)  that consists of  exercise 

 
 
 
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counseling matched to participants’ motivational readiness, exercise logs, a pedometer 
(Digiwalker) and feedback reports.  These components are: a) Exercise Counseling:  RTR 
coaches will be asked to contact participants by telephone weekly over 3 months (12 calls).  
Each call will take about 10-15 minutes.  The purpose of these contacts is to build a supportive 
relationship with the participant, assess motivational readiness, monitor exercise participation, 
identify any health concerns, assist the participant to identify relevant barriers to exercise and 
help her to problem solve to overcome such barriers.  In addition, the coach will provide 
feedback, reinforce and encourage efforts to start or stay active. The counseling will be matched 
to the patient’s motivational readiness assessed at the start of each call. Women in the 
precontemplation stage will be given messages to increase their awareness of the benefits of 
exercise after cancer treatments (e.g., improved physical functioning). Those in the preparation 
stage will receive specific information on how to increase exercise in a safe and appropriate 
manner (e.g., to reduce risk of lymphedema).  
The goal for the 3-month program, as in prior work, will be to gradually increase the amount of 
moderate-intensity aerobic exercise that is performed, for example, increased walking, yard 
work, and sport  if appropriate, to the current recommendations of at least 150 minutes of MVPA 
per week.10,45  Previous studies have shown that walking is the preferred form of exercise 
among U.S. adults and cancer survivors.46  If participants have access to home exercise 
equipment, they will be free to participate in moderate-intensity exercise of their choice. Our 
goal is to promote aerobic exercise that is feasible and enjoyable for participants. 
Motivational readiness for exercise (assessed at each call) is a key construct of the intervention.  
As in our prior work (Preliminary Studies, B.1. and B.2), the coaches will be trained to tailor the 
exercise counseling to the participant’s stage of readiness. The strategies for working with 
participants in Precontemplation stage of readiness are different from patients in Preparation. 
For example, action-oriented messages (e.g., “it is important for you to remind yourself to 
exercise”) would not appropriate to someone who is not intending to start becoming active.  The 
supervision of exercise coaches will include attention to tailoring to motivational readiness.  
Similarly, the audio-taped calls will be audited for attention to motivational readiness both as a 
content component and a process element.     
A key element in RTR coaches offering the intervention is that they are peers who have also 
survived breast cancer.  In this sense, they can relate to the patient from a different perspective 
than research staff.  Participants and coaches can share their experiences with cancer 
diagnosis, treatment and recovery.  However, the coaches will be told NOT to provide medical 
advice and will be trained to encourage participants to contact their oncologist/primary care 
physician for medical care/health issues. If participants report symptoms such as chest pain or 
difficulty breathing, participation will be temporarily suspended and they will be referred to their 
oncologist (See section on coach training).  
b) Exercise Logs: As in our prior work, participants will be asked to monitor frequency, duration, 
and intensity of exercise and any side-effects on exercise logs during the 3-month program.  
Heart rate monitors and pedometers will be provided and readings will be recorded on exercise 
logs as we have done previously.41,42  The coach will review the weekly logs during calls and 
help to problem solve barriers to exercise.  We will use incentives to encourage maintaining 
logs.22,25  c) Pedometer: Participants will be encouraged to use a pedometer (Digiwalker) during 
aerobic exercise such as walking and record steps on the exercise logs.  d) Feedback reports: 
Participants will receive these reports at 2, 4, 8 and 12 weeks (Preliminary Studies, B.2) that 
summarize their progress, barriers they identified during the calls and ways to overcome the 
barriers as discussed during the calls.   
 
Maintenance Program (Months 4-9). Unlike our previous RCT, after the 3 months are 

 
 
 
Page 11 of 22 
 
completed, participants will be provided exercise logs for the remaining months. They will be 
encouraged to use the heart rate monitors and pedometers during exercise. They will be asked 
to mail/e-mail the logs to study staff each month and a monthly feedback report showing their 
progress and encouraging exercise maintenance will be sent to them.  Participants can choose 
mail or email as their preferred mode. Incentives ($25) will be provided for those who return at 
least 80% of the logs.  Self-monitoring is an evidence-based technique for behavior change47 
and we expect that providing feedback reports will be a less costly approach that CBOs can 
implement to support exercise over the long-term.  
Reach Plus Phone. As noted earlier, participants in this group will receive the same 3-month 
exercise counseling intervention described above for Reach Plus. However, after the 3-month 
assessments have been completed, the coaches will be asked to continue to contact their 
participant each month during Months 4-9 (one call per month, a total of 6 additional calls). 
These calls are expected to take about 10 minutes. We chose to extend and taper the calls from 
the coaches because: a) Participants in our prior trial (Preliminary Studies, B.2.)  rated the 
telephone calls from the coaches as the most helpful program component (mean of 4.97, scale 
1-5, 1=not at all helpful, 5=very helpful) and so we have retained this highly rated intervention 
contact, b) Among those who made recommendations to improve the intervention (n=17), 58% 
expressed a preference for a longer contact with the coach, and c) The literature on PA 
interventions shows that those of longer duration (>6 months) had better maintenance, so we 
have extended and tapered the contact beyond 3 months to Month 9.37  We will focus the calls 
on principles from Social Cognitive Theory48 and Relapse Prevention Theory30 and the 
participant’s stage of motivational readiness. As in Months 1-3, all calls will begin with an 
assessment of exercise and motivational readiness so that the calls are tailored to motivational 
readiness. In addition, the calls will target self-management approaches including cognitive 
(goal setting, identifying barriers and problem solving), behavioral (self-monitoring using 
exercise logs and the pedometer) and environmental strategies (developing social support) that 
have been recommended for exercise maintenance.49 The call content will include a brief review 
of monthly exercise logs, problem solving and negotiation of exercise goals for the next month. 
Specific attention will be made to prevent lapses to sedentary behavior by anticipating and 
preparing for lapses, developing a plan to recover from lapses and return to regular exercise 
and developing and using social support for sustaining exercise. Participants will be asked to 
monitor their exercise using  logs (they will be encouraged to use the heart rate monitors and 
pedometers) for which they will receive an incentive ($25), mail/email the exercise logs back to 
the research staff and a monthly feedback report will be mailed/e-mailed to the participant 
(participants can choose preferred delivery mode). Our experience and those of other 
researchers50 show that exercise maintenance can be enhanced by using periodic phone 
contact to address patients' concerns and to review exercise logs. Hence, these participants will 
have the opportunity to continue to receive support from their coach during brief calls in Months 
4-9.  
Reach Plus Messages. As noted earlier, participants in this group will receive the same 3-
month exercise counseling intervention described above for Reach Plus.  However, after their 3-
month assessments have been completed, participants will receive brief messages by email or 
text (participants can choose their preferred mode of contact) to motivate, prompt and reinforce 
continued exercise.  The rationale for this approach is based on: a) the literature where 
prompts/reminders have been found to be effective to sustain behavior change 38,51 and b) 
feedback from the ACS on maintenance techniques that are feasible for the organization (per 
consultation with Dr. Kevin Stein, National ACS). Although ACS uses various communication 
methods to reach constituents, email is the “go-to” channel for most of their communications 
(personal communication, Ms. Hilary Noon, Vice President Custom Experience, Insight & 
Analytics). These messages will be sent by the research staff in collaboration with the RTR ACS 

 
 
 
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executive and will be personalized using both the name of the participant and name of her 
coach. An example: “Hello (participant’s name), your coach, Ann, and the RTR program would 
like to remind you that staying physically active will provide you both mental and physical health 
benefits. We encourage you to exercise for at least 150 minutes each week.” The messages are 
intended to support motivation for exercise, remind participants of the benefits of exercise for 
cancer survivors and provide encouragement to stay active. The messages will be tailored to 
the stage of readiness and exercise reported on the previous assessment (i.e., message in 
Month 5 tailored to readiness for exercise reported in Month 4). We will develop a standardized 
message specific to each stage of readiness: for example, women in Preparation will hear the 
same message but individualized using the name of the specific coach. We will develop a library 
of 24 messages for each stage of readiness over the 6-month maintenance phase.  There will 
not be an opportunity for the coach to counsel the participant during Months 4-9 and for the 
participant to interact with the ACS as a contrast to Reach Plus Phone.  The messages are 
purposefully meant to be a brief, potentially low-cost, feasible approach that the ACS can 
implement to help survivors stay physically active. There will be a total of 24 messages during 
Months 4-9 (one message/each week). Participants will be expected to monitor their exercise 
using exercise logs (they will be encouraged to use the heart rate monitors and pedometers) for 
which they will receive an incentive ($25), mail or email the exercise logs back to the staff on a 
monthly basis and a feedback report will be mailed (or e-mailed) to the participants (Months 4-
9).   
 
D.6. Training Exercise Coaches. Dr. Pinto will train the coaches in-person at the collaborating 
ACS offices or via videoconferencing. Based on our prior trial (Preliminary Studies, B.2), we 
anticipate that 4 sessions each lasting about 2 1/2 hours will be needed for training. Session 1 
will consist of didactics on benefits of exercise for cancer survivors, and a review of the manual.  
Sessions 2-3 will focus on skills and counseling techniques (e.g., empathy, reflective listening), 
didactics on the use of the TTM Model and social cognitive theory to promote exercise adoption 
and maintenance, working with human subjects and HIPAA regulations, as well as emergency 
protocols if participants report potentially dangerous health symptoms during or after exercise 
(e.g., chest pain) or report emotional distress.  Coaches will be trained to query participants at 
each call about a list of symptoms and notify research staff immediately if participants endorsed 
any symptoms that the trainers noted were potentially indicative of a serious problem. In these 
cases, study participation will be temporarily suspended until the medical issue has been 
resolved. If participants become distressed, appropriate referrals will be made. Training 
methods will include listening to audiotapes of exercise counseling and practice role-plays with 
trainer feedback. For the proposed study, we will also add training to focus on exercise 
maintenance in Session 4 (for the Reach Plus Phone group), with additional role plays on lapse 
prevention and lapse recovery for exercise maintenance. To determine proficiency, we will train 
coaches to demonstrate key skills with 3 standardized participants; training will end when 
coaches can cover at least 80% of the content areas, and demonstrate a score of >4 on each of 
8 process indicators (1-5 rating scales).  Additional training will be offered until criteria are met.  
All training materials are already available.  
 
D.7.Quality Control. All telephone contacts with participants will be audio taped. The Project 
Coordinator II will review a random sample of 50% of the contacts weekly to monitor safety and 
fidelity to protocol.  Dr. Pinto will audit a random sub-sample (10%) of the calls in each group for 
quality control. The Project Coordinator II will provide feedback and supervise the coaches 
during bi-weekly telephone supervision.  Corrective feedback will be provided.  Booster training 
will be provided periodically in Years 02-04. Quality control procedures will help ensure that 
coaches adhere to the protocol for each arm to minimize potential contamination across 
conditions and/or differences in enthusiasm for one condition vs. the other.  

 
 
 
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Table 1: Assessment Schedule for Participants 
 
Baseline 
3M 
6M 
9M 
12M 
Patient demographics 
x 
 
 
 
 
Medical chart 
information 
x 
 
 
 
 
7 Day PAR 
x 
x 
x 
x 
x 
Actigraph 
x 
x 
x 
x 
x 
Fact-F (Fatigue) 
x 
x 
 
x 
x 
FACT-B (QOL) 
x 
x 
 
x 
x 
Profile of Mood States 
x 
x 
 
x 
x 
SF-36 Health Survey 
x 
x 
 
x 
x 
Motivational Readiness 
x 
x 
x 
x 
x 
Social Support for 
Exercise 
x 
x 
x 
x 
x 
Self-Efficacy for 
Exercise 
x 
x 
x 
x 
x 
Physical Activity 
Enjoyment 
x 
x 
x 
x 
x 
Exercise Barriers 
x 
x 
x 
x 
x 
Intervention evaluation 
 
x 
 
 
x 
 
D.8. System Support for Coaches. The coaches in our prior work (Preliminary Studies, B.1. 
and B.2.) were very satisfied with study participation.  Based on their feedback, factors such as 
the convenient access to the training location, food at the training sessions, and telephone 
supervision (rather than in-person supervision) during intervention delivery were cited as 
important to their volunteer roles in this research collaboration. Hence, we plan to offer food at 
training sessions, small incentives to the coaches (e.g., $25 gift certificates) and supervision via 
telephone to support their roles.  We will provide them audio-taping equipment.  
D.9. Measures to Ensure Internal Validity. The following steps will be taken to assess 
possible threats to internal validity and/or alternative explanations of significant effects or failure 
to find effects:1) Treatment Validity:  Protocols will be used for the phone calls in all groups for 
the first 3 months as well as the monthly phone calls for the Reach Plus Phone group during 
Months 4-9. To ensure fidelity in the interventions, we will ask coaches to audio tape their calls 
to participants.  Review and auditing of calls has been described previously.  We will provide re-
training if drifts from study protocol are noted.  Participants will be asked to evaluate the benefits 
of the calls and the general social support of the phone contact.  
2) All participants will be asked at 3, 6, 9 and 12 months if they have received counseling and/or 
sought other treatments that may attenuate fatigue and other outcomes.  Participation in other 
exercise or psychosocial programs will confound our results and hence, we will collect data on 
such participation, and use it as a co-variate in the outcome analyses. 
E. Outcome Measures. Similar to our prior work (R01 CA 132854),assessments at 3, 6, 9 and 
12 months will follow the same procedures as for the baseline assessments: the questionnaires 
and accelerometers will be mailed to participants. When the completed questionnaires and the 
units are returned by mail, the Project Coordinator I (“blind” to the participant’s group 
assignment) will call the participant and conduct the 7 Day PAR interview by phone. Participants 
will receive $25 for completing the assessments at each time-point ($25 X 5=$125). Note: At 6 
months, women will complete only a partial selection of exercise and measures of psychosocial 
constructs to conduct mediational analyses, increase power and for comparison with our prior 
trial (R01 CA 132854). The full 
battery of assessments includes: 
E.1.Primary Outcome (Aim #1) 
1. Seven Day Physical Activity 
Recall (7 Day PAR).52 This 
interviewer-administered measure,53 
is widely used and validated 
measure of occupational and leisure 
activity. It assesses hours spent in 
sleep, moderate activity, hard and 
very hard activity. Caloric 
expenditures are estimated based 
on the metabolic equivalents for the 
different activity classes. We will 
obtain the total minutes of MVPA as 
our key outcome measure, similar to 
other national trials of exercise 
programs.54  We will administer the 7 
Day PAR by telephone at each time-
point. 

 
 
 
Page 14 of 22 
 
2. Accelerometer: As in the prior RCT, we will use the Actigraph accelerometer (GT3X) as an 
objective measure of exercise. Participants will be asked to wear the Actigraph for 7 days at 
each assessment point (concurrent with the seven days of the 7 Day PAR interview).  Based on 
our prior work and the work of other researchers,55,56 we expect that any reactivity to wearing 
the units will be similar in the study groups at baseline, and that reactivity will decrease in all 
groups over time.  
The following questionnaires will be mailed to participants at each assessment and returned by 
mail. The Project Coordinator I will review completed questionnaires and re-contact participants 
to minimize missing data.  
 
E. 2. Secondary Outcomes (Aim #3). QOL, physical functioning, fatigue and mood will be 
assessed using standardized questionnaires: Functional Assessment of Cancer Therapy Scale-
Breast (FACT-B),57 36-item Short Form Health Survey that includes a Physical Functioning 
subscale,58 Functional Assessment of Cancer Therapy Scale-Fatigue (FACT-F),59 and the 
Profile of Mood States.60  
 
Questionnaires will be used to assess constructs relevant to the TTM and SCT:  Stage of 
Readiness for Exercise61 and Exercise Self-Efficacy62 that are designed for telephone or mail 
administration. Motivational readiness and self-efficacy will be examined as a potential 
moderator and mediator (respectively) of intervention effects. 
 
E.3. Potential Mediators. (a) Social Support.  We will use the Social Support for Exercise 
Survey, a reliable scale that assesses support from friends and from family members63  to 
assess the meditational role of this construct. (b) Physical Activity Enjoyment.  This construct 
will be assessed using the 18-item Physical Activity Enjoyment Scale.64  Participants will be 
asked to rate “how you feel at the moment about the physical activity you have been doing,” 
using a 7-point bipolar rating scale.  Enjoyment has been found to predict exercise 
maintenance.49 (c) Exercise Barriers. This 21-item measure assesses how often situational 
barriers prevented participants from being active in the previous 3 months and a composite 
barriers score will be determined49. (d) Exercise Coach. Coaches will be included as a random 
effect. 
E.4. Exercise Adherence. Participants will be asked to maintain exercise logs (i.e., the 
frequency, duration and type of exercise, heart rate during exercise, pedometer steps and any 
health problems). Coaches will review the logs during weekly calls in Months 1-3 (Preliminary 
Studies B.1-B.2). Similar logs will be used by all participants during Months 4-9 and sent to 
research staff. Incentives will be provided for maintaining the logs.  
 
E.5. Adverse Effects of the Interventions (Aim #4).  As in previous studies, during telephone 
calls (Months 1-3), the coach will review the exercise logs and ask questions about any 
problems related to exercise to track adverse events.  During Months 4-9, participants will be 
asked to report any adverse events (e.g., sprains, chest pain) to the study staff when they occur 
and record these events on the exercise logs.  
 

 
 
 
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Table 2: Assessment Schedule for RTR 
Coaches 
 
Study 
Start 
Post-
training 
Study 
end 
Demographics 
Knowledge of exercise, 
and beliefs about exercise 
x 
x 
 
 
Knowledge test 
Confidence in exercise 
counseling 
Training evaluation 
 
x 
x 
x 
 
Final evaluation (study and 
intervention) 
 
 
x 
E.6. Evaluation of the Interventions. a) Coach Evaluations. At the end of their study 
participation, all coaches will complete an evaluation of the training and supervision. The 
perceived acceptability and usefulness of the interventions will be assessed using a 
questionnaire (Preliminary Studies, B.1 and B.2). b) Participant Evaluations. At 3 months and at 
12 months, all participants will evaluate the intervention they received and its components (e.g., 
usefulness of calls, email messages) as we have done in prior trials.22,65  
E.7.Fidelity of Interventions.  In addition to quality control procedures, we will record the 
number and the duration of calls delivered to all study participants in Months 1-3.  Such tracking 
will continue during Months 4-9 in the Reach Plus Phone group.  We will track exercise logs 
received during Months 4-9 and feedback reports sent to all participants. We will track the 
number of email/text messages sent to the Reach Plus Messages group in Months 4-9. These 
data will be indicators of fidelity in intervention implementation. 
E.8. Background Variables. These variables are the participant and coach characteristics that 
may affect MVPA, our primary outcome. Participant Characteristics. (1) Baseline demographic 
Information (age, marital status, ethnic group, education, etc.) will be assessed using standard 
questions from national surveys. (2) Disease and treatment variables: The participant’s disease 
and treatment history (date of cancer diagnosis, cancer stage, treatments received) will be 
extracted from medical records after obtaining permission during informed consent procedures. 
If women refuse to give permission, they will not be eligible for the study.  
 
E.9. Coach Characteristics. Prior to training, coach characteristics such as age, time with RTR 
as a volunteer, time since diagnosis of breast cancer and experience with exercise counseling 
will be assessed with a brief 
questionnaire.  We will also assess their 
knowledge and beliefs about exercise 
counseling using a questionnaire 
(Preliminary Studies B.1-2).  At 
posttraining, a brief assessment of 
knowledge about exercise counseling, 
confidence in providing counseling and 
an evaluation of the training will be 
conducted.  At study end, coaches will 
be asked to evaluate the interventions 
they delivered. 
 
E.10. Cost Effectiveness (Aim 2). Cost-effectiveness analysis is a method for assessing the 
relative value of health programs.45,66  We will collect data on costs of delivering each 
intervention to better understand the potential for disseminating the intervention(s).  To date, 
very few studies that offered an exercise intervention for cancer survivors has provided data on 
costs.8  Data collection and analysis will follow guidelines of the Public Health Service Panel on 
Cost-Effectiveness67 and other well-established recommendations.68 Intervention costs will 
include costs of training the coaches, the marginal costs of personnel, printing, postage, 
telephone and facility costs.  Personnel costs will be calculated from intervention delivery by the 
coaches, time logs maintained by the Project Coordinator II (who will supervise the coaches, 
enter exercise log data and generate feedback reports, and coordinate with the RTR executives 
to provide the email/text messages for the Reach Plus Messages group) and other key 
personnel. The analysis will include costs associated with the time required for intervention 
tasks and training but not research assessments (screening, randomization, questionnaires and 
other assessments). The research team has experience with developing time-tracking systems 
that capture information at the researcher level (CA 101770, B. Pinto, P.I.). Printing, postage and 

 
 
 
Page 16 of 22 
 
telephone expenses will be tracked by setting up separate purchase order accounts for 
intervention materials and tasks. For participant costs, we will obtain information at 3, 9 and 12 
months on the cost of exercise equipment, gym fees, and any medical expenses incurred by the 
participants for exercise-related injuries.   
We will evaluate the impact of the intervention on QOL using the Short-Form-36 (SF-36) 
Health Survey. Questions about medical conditions will also be added to allow for case-mix 
adjustment of SF-36 scores. The SF-36 will be administered at baseline, 3, 9 and 12 months. 
The cost-effectiveness of our interventions will be estimated using the ratio of the difference in 
costs between Reach Plus Phone, Reach Plus Messages and Reach Plus to the difference in 
QOL and other outcomes at 12 months. The general equation for a cost-effectiveness ratio 
(CER) is: 
 
Where i is the i-th participant, cost is determined by resource utilization (as described above), 
and effectiveness is measured by QOL and quality-adjusted life-years (QALYs). QOL will be 
converted to health utilities, a measure of quality of life on a scale from 0 (death) to 1 (perfect 
health).69 We will construct confidence intervals for our cost-effectiveness ratio using 
nonparametric bootstrapping.70-72 Bootstrapping is a re-sampling technique that empirically 
estimates a sampling distribution for the cost-effectiveness ratio. Bootstrap samples are 
constructed by sampling the original data with replacement, with a sample size equivalent to the 
original data. The cost-effectiveness ratio is calculated using the mean cost and QALYs in the 
bootstrap sample. This process is repeated a large number of times (at least 1000 bootstrap 
samples are recommended) to estimate the sampling distribution of the cost-effectiveness ratio. 
A 95% confidence interval can be constructed by identifying the 26th least favorable and 975th 
most favorable cost-effectiveness ratios. The cost and QALY outcomes from each bootstrap 
sample will also be plotted on a cost-effectiveness plane. 
F. Data Analyses 
F.1. Preliminary analyses.  We will assess potential between-group differences in baseline 
characteristics (socio-demographics, baseline exercise, mood, fatigue, QOL and physical 
functioning) using graphical methods, non-parametric and parametric tests as appropriate (e.g., 
Wilcoxin rank-sum test for skewed data, analysis of variance for normally distributed continuous 
data & chi-squared tests for categorical data). Any variables not balanced by randomization will 
be controlled for as covariates in subsequent analyses. 
 
F.2. Primary Aim Analysis Plan. We will compare the three groups with respect to mean 
weekly minutes of MVPA (as measured by the 7-day PAR) at 3, 6, 9 and 12 months (Primary 
Aim 1). To avoid the effect of outliers, we will apply a normalizing transformation (if necessary) 
to the outcome prior to analysis.  A single linear mixed effects regression model will be used to 
simultaneously estimate the intervention effects (Reach Plus vs. Reach Plus Phone, Reach Plus 
vs. Reach Plus Messages and Reach Plus Phone vs. Reach Plus Messages) on MVPA at 3, 6, 
9, and 12 months, with a subject-specific intercept included to account for within-subject 
correlation in the outcome over time.  We will control for baseline value of the outcome and 
potential confounders of treatment effects (including any variables not equally distributed 
between groups).  Modeling is done using a likelihood-based approach and will make use of all 
available data (on the ITT sample) to obtain consistent estimates of the regression parameters. 
Finally, using Spearman rank order correlations, we will assess the agreement between self-
reported (7 Day PAR) and objectively measured (accelerometer) MVPA.  
 

 
 
 
Page 17 of 22 
 
F.3. Secondary Aims Analysis Plan (Aim 3). Using a similar analytic strategy to that 
described for the Primary Aim, we will assess potential between-group differences in fatigue, 
QOL, physical functioning and mood at 3, 9 and 12 months.  A series of linear mixed effects 
regression models will be run (with subject-specific intercepts), to regress secondary outcomes 
at follow-up on intervention assigned, baseline values of the outcome and potential confounders 
(including any variables not balanced by randomization). Descriptive data will be maintained on 
any adverse effects associated with exercise participation by group (Aim 4). 
 
F.4. Analysis Plan for Additional Exploratory Aims (Aim 5). Potential Moderators will be 
examined using similar linear mixed effects regression models, as those described above. For 
example, MVPA at 3, 6, 9 and 12 months will be regressed simultaneously on the moderator 
(e.g., age), treatment assignment, and the interaction between the two. If the interaction term is 
nonzero, then we will conclude that there is evidence for a potential moderator. Models will also 
control for any potential confounders of the association, including baseline exercise and any 
variables unbalanced between groups. Given the limitations of our sample size, interest will be 
in exploring effect sizes to generate hypotheses about the potential differing effects of the 
interventions on exercise maintenance at follow-up.  Potential Mediators of the intervention 
effects on MVPA at follow-up will be explored. Mediators of interest are self-efficacy, barriers to 
exercise and social support for exercise, as suggested by prior work.73 Following Kraemer’s 
approach,74,75 a potential mediator must be in the causal path from intervention to outcome. For 
a variable M to be a mediator, we must show that (a) intervention assignment has a causal 
effect on M, and (b) M has a causal effect on the outcome. Testing condition (a) is more 
straightforward, as interventions are randomized. Since M is a post-randomization variable, 
testing condition (b) can be challenging. Our primary approach for testing potential mediators 
will be principal stratification.76,77 This method can help estimate the causal effect of a post-
randomization variable (such as a potential mediator M) on the outcome. We will compare these 
findings to that of more standard approaches.78,79 Our sample size may not always provide 
sufficient power to simultaneously test for all possible mediators, but the individual mediation 
analyses will provide data for generating hypotheses about the mechanisms through which the 
intervention can impact exercise maintenance. Hence, our focus will not be on strict significance 
testing but rather estimating effect sizes and corresponding confidence intervals. 
 
F.5. Missing Data Approaches.  If a participant drops out, we will attempt to gather follow-up 
data. If women refuse to be contacted or lose contact with the study, we will censor the data at 
the point of loss. Our analyses will focus on the intent to treat (ITT) sample (all randomized 
participants will be included). The MIXED procedure in SAS 9.3 (which will be used for our 
primary and exploratory analyses) uses maximum likelihood (ML) approaches to produce 
estimates of the regression parameters. A ML approach makes use of all available data (e.g., 
does not drop a woman with missing 12-month data but observed baseline and 9-month data), 
without requiring imputation of missing values. ML estimates are consistent when missing data 
are related only to covariates and observed values of the outcome.80 As it is possible (although 
not testable) that missingness may be related to the missing outcome, we will run a sensitivity 
analysis to explore the robustness of our results to various other assumptions of the missing 
data.  
 
 
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