Pink Warrior 2.0: Teleconference Support Group Toolkit for Breast Cancer Survivors
Phase: NA
Conditions: Breast Cancer, Physical Activity
Sponsor: The University of Texas Medical Branch, Galveston

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Title: 
Pink Warrior—Support Group Toolkit for Breast Cancer Survivors 
  
 
Principal Investigator:  
Elizabeth J. Lyons (UTMB) 
 
Collaborators: 
 
 
Eloisa Martinez (UTMB) 
 
 
 
 
Rachel Deer (UTMB) 
 
 
 
 
H. Colleen Silva (UTMB) 
 
 
 
 
V. Suzanne Klimberg (UTMB) 
 
 
 
 
Julie Park (UTMB) 
 
 
 
 
Sandra Hatch (MD Anderson Cancer Center/UTMB Contract) 
 
 
 
 
Rohit Venkatesan (MD Anderson Cancer Center/UTMB Contract) 
 
 
 
 
Maria C. Swartz (Co-PI, MD Anderson Cancer Center) 
 
Funding Sponsor: 
President’s Cabinet Award at The University of Texas Medical   
Branch (Cohort 1 to 3) and The Claude D. Pepper Older Americans 
Independence Center (OAIC) Pilot (grant number P30AG024832) 
and Sealy Center on Aging (Cohort 4) 
 
Clinicaltrials.gov ID: 
NCT04259905 (Please note that this identifier refers specifically to 
Pink Warrior 2.0, cohort 4 of the larger protocol) 
 

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Table of Contents: 
 
Study Schema 
1.0  
Rationale and Specific Aims 
2.0  
Background and Significance 
3.0  
Preliminary Studies 
4.0  
Research Design and Methods 
5.0  
Potential Risk to Participants or Others 
6.0  
Study Withdrawal/Discontinuation 
7.0  
Statistical Considerations 
8.0  
Potential Difficulties and Limitations 
9.0  
Ethics and Protection of Human Subjects 
10.0  Data and Safety Monitoring Plan 
11.0  References 
12.0    List of Appendices  
 
 
 

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1. Specific Aims 
 
Increasing and maintaining physical activity among female breast cancer (BC) survivors 
remains an unresolved problem in BC survivorship care.1 BC survivors, from diagnosis until the 
end of life, go through many transitions. One major transition is the significant decline of 
physical activity immediately after diagnosis. Despite the known benefits of PA—speeding 
recovery time and reduced cancer recurrence risk—less than 30% of survivors met PA 
recommendations.2 PA interventions have shown effectiveness in helping BC survivors 
increase PA, but limited evidence-based PA interventions have been disseminated into the 
clinic and community.1 To address this limitation, we are partnering with the UTMB breast 
cancer support group to conduct a12-week physical activity intervention, Pink Warrior, which 
will investigate the feasibility of implementing active video game-based physical activity 
intervention among BC survivors within the support group setting.  In cohort 1-3 participants (N 
= 60) will be randomized to participate in the support group using the active video game-based 
physical activity intervention or to participate in the existing UTMB breast cancer support group 
with pedometers. In the fourth cohort, participants (N=20) will be recruited and randomly 
assigned to intervention or control condition.   
 
Our specific aims are: 
 
Aim 1:  Evaluate the feasibility and acceptability of active video game-based physical 
activity intervention among BC survivors within the support group setting. Measures of 
feasibility will include weekly attendance records, number of completed home-based 
worksheets, and number of participants completing the program activities, technological 
issues, and adverse events. 
 
Aim 2:  Compare the support group using the active video game-based physical activity 
intervention to a control condition (cohort 1-3: existing UTMB breast cancer support 
group with pedometer; cohort 4: Telephone-based weekly support group with UTMB 
support group). Primary outcomes will be changes in physical activity. Secondary outcomes 
will be changes in physical function, dietary pattern, and quality of life. 
 
Aim 3: Develop tools for implementation of the Pink Warrior intervention within the 
clinic and community settings. A trainer’s manual for the Pink Warrior intervention will be 
developed and UTMB Breast Cancer Support Group facilitators will be trained by research 
staff to implement the program. 
   
The feasibility and acceptability findings from the intervention along with stakeholder input 
will guide the refinement of the Pink Warrior intervention for larger efficacy trials. This project 
will lay the ground work for accelerating disseminating a state-of-the art evidence-based 
program into the community and address a pressing need among BC survivors.   
 
2. Background and Significance 
 
The impact of physical activity on survival and health related quality of life is immense for 
BC survivors, especially with the growing survivor population. According to the 2010 Cancer 
Prevention and Research Institute of Texas report 14,163 new cases of female BC were 
diagnosed in Galveston and surrounding counties. In comparison to the rest of Texas, the 
incidence rate for female BC was significantly higher for Galveston and the surrounding 

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counties.3 Higher cancer incidence leads to more cancer survivors living in Galveston. These 
increasing evidence shows that physical activity is a powerful tool that can reduce the severity 
of these side effects without adverse consequences.4,5 Activity reduces the risk for declines in 
physical function.6 Function, especially of the lower body, is critical to survivors’ perceptions of 
their quality of life.6,7 Intervening to prevent or reduce functional deficits would produce lasting 
benefits on BC survivors’ quality of life.6 
 
Despite the known benefits of physical activity among BC survivors, fewer than 30% of 
survivors meet the minimum physical activity recommendation of 150 minutes of moderate-
intensity activity per week.2 In fact, survivors were found to be similarly inactive or even more 
inactive than the general population or other populations with chronic conditions.1 Furthermore, 
research has shown that BC survivors experience a significant decline of physical activity (2 
hours/week less) after diagnosis compared to their pre-diagnosis activity levels.8 This 
significant decline persisted 10 years post-treatment.9 Common issues affecting physical 
activity level among BC survivors include:  lack of a belief in their ability to be physically active 
(known as self-efficacy10), competing demands, lack of motivation, and fatigue.11,12 Given both 
the benefits of physical activity and the increased number of BC survivors in Galveston 
County, there is a tremendous need for physical activity programs that target the specific 
needs and barriers of BC survivors.   
 
Physical activity programs that provide a pedometer and instruction have shown 
effectiveness in helping BC survivors increase physical activity.13,14 However, the findings from 
research has not been adequately incorporated into clinical practice or community 
programming, a process called dissemination.1 Wide dissemination of evidence-based 
physical activity programming into the clinic and community could greatly benefit BC survivors 
at a population level. Two main barriers to disseminating these programs are cost and not 
providing what the community wants. First, physical activity programs designed for the 
research setting often are costly because they require a team of highly skilled staff.1 Second, 
a recent review found that as many as 62% of the 122 physical activity programs were 
implemented under one setting—individual or group-based.15 However, BC survivors have 
indicated a need for program to be offered with a mix of individual and group-based settings.12 
Thus, in addition to addressing survivors’ barriers, physical activity programs would ideally be 
evidence-based, include social activities, and be low-cost.  
 
Recent technology advances have produced methods that allow for low-cost, flexible 
physical activity programming.16 Electronic fitness trackers and active video games contain 
evidence-based behavior change techniques similar to those used in research 
interventions,17,18 but can be implemented at lower cost and can be used in a variety of 
settings. Fitness trackers expand upon pedometers’ limited feedback by providing goal-setting 
assistance, extensive feedback on progress, and encouraging social comparison and 
interaction.18 Active video games perform similar functions, but also provide opportunities for 
strength training (i.e. balance games) and can increase motivation to maintain activity over 
time.16 Substantial research reports that women with chronic conditions and older women are 
willing to use new technologies19,20 and that fitness trackers and active video games are 
effective at promoting physical activity.16,21  
 
To address these limitations, we created Pink Warrior, a 12 week program to improve 
physical activity among BC survivors that can easily be integrated into existing infrastructure at 
the UTMB Breast Cancer Support Group. Pink Warrior will develop and implement a toolkit 

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that can be used by BC support groups to encourage physical activity among women BC 
survivors. Evidence-based strategies such as setting goals, self-monitoring, giving feedback on 
progress, and using group-based video game play to increase motivation to be active will be 
included.  
 
The UTMB Breast Cancer Support Group is an excellent intervention partner for three main 
reasons. First, the UTMB Breast Cancer Support Group is facilitated by the experienced 
clinical staff of the UTMB Breast Health and Imaging Center at Victory Lakes. Currently the 
group provides informational and peer support for BC survivors and is respected by the 
community. Second, the UTMB Breast Health and Imaging Center that has become a premier 
BC care center for residents in Galveston County area and its affiliated support group is well 
known in the community. By building a partnership between researchers and stakeholders—
clinicians, staff, and survivors—we will be able to disseminate effective physical activity 
interventions or programs that will serve the BC survivor community and increase the center’s 
community outreach capacity. Third, clinic staff report a need for a structured curriculum that 
uses physical activity to help BC survivors cope with their treatment. Thus, the Pink Warrior 
intervention will address this existing need in the community.  By using support group 
facilitators to promote physical activity, we will be able to reach more BC survivors during and 
after active cancer treatment to prevent significant physical function declines and positively 
impact BC survivors’ quality of life.   
 
3. Preliminary Studies 
 
Our lab has conducted focus groups with 20 local BC survivors aged 55 to 79 to identify a 
list of active video games they find most appealing. Seven of the BC survivors indicated 
previous experience of using Nintendo Wii console, but nearly all expressed interest in active 
video games provided that instructions are given ahead of time. General acceptance of the 
active video games, especially Nintendo Wii, in the older adult population can also be found in 
the literature.22-24   
 
The evidence based physical activity intervention the Pink Warrior was adapted from the 
Active Living after Breast Cancer (ALABC) program. The ALABC program focused on adding 
physical activity into daily living through a group-based program. ALABC used behavior 
change strategies and skill-building to gradually increase physical activity. ALABC was tested 
previously in a randomized controlled trial, which found improved physical functioning—less 
pain and less daily activity limitation—after the intervention. Furthermore, the ALABC program 
was chosen because it was designed to meet the unique needs of BC survivors by providing 
breast cancer-specific support and resources. However, the ALABC requires a highly skilled 
team to implement the program and has a focus on group-based intervention. Pink Warrior will 
adapt the ALABC program, and will include active video gaming technology and written 
“toolkit” materials that allow modestly ted support group leaders to implement the program.   It 
will incorporate both a group-based and individual-based component, to satisfy the needs of 
the survivors.12 
 
4. Research Design and Methods  
 
This study will evaluate the feasibility and acceptability of active video game-based physical 

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activity intervention among BC survivors within the support group setting.  In addition, we will 
also compare the changes in physical activity among participants who were in the active video 
game-based physical activity intervention support group to those who were in the existing the 
UTMB breast cancer support group.  Participants (N=60) will be randomized to participate in 
the support group that uses the active video game-based physical activity intervention 
(intervention group) or in the existing UTMB breast cancer support group with pedometers 
(control group) for 12 weeks.  The home-based self-paced portion of the intervention will 
mainly be delivered through the participant manual.  In the fourth cohort, BC survivors (N=20, 
aged 55 to 79 due to the aging grant restrictions) will be recruited and randomly assigned to 
intervention or control condition for a 12-week period. The intervention group will participate in 
weekly active video game web-based group sessions. The control group will receive weekly 
conference calls plus wearable tracker to track their physical activity for 12 weeks. 
 
4.1 Theoretical Framework.  The theoretical framework used for the Pink Warrior 
intervention (see Fig. 1) are based on the constructs from the Social Cognitive Theory (SCT)10 
and Self-Determination Theory  (SDT).25  Under 
SCT we will mainly focus on the self-efficacy 
and the self-regulation constructs.  Self-efficacy 
and self-regulation constructs have been shown 
to be associated with initiation and increase of 
physical activity.26  However, researchers have 
found that increasing autonomous motivation 
under SDT is important to promote physical 
activity over time.27  The autonomous motivation 
include the identified regulation (i.e. value 
physical activity and accepted that the behavior 
is his/her own behaviors), integrated regulation 
(i.e. being physically active is consistent with 
his/her own sense of self), and intrinsic 
motivation (i.e. motivation to be physically active 
because of interest and enjoyment).25  Based on SDT, fulfillment of basic psychological needs 
for autonomy, competence, and relatedness will help to promote intrinsic motivation and lead 
to an increase in physical activity.28 Therefore, we have created the Pink Warrior intervention 
to increase participants’ autonomous motivation to engage in physical activity through targeting 
the self-efficacy (task and barrier), self-regulation, autonomy, competence, and relatedness 
constructs.   
 
The behavioral change method we will use to target the theoretical constructs central to the 
Pink Warrior intervention are outlined in Table 1. 
 
Table 1. Theoretical constructs, behavioral change methods, and intervention components. 
Theoretical 
construct29 
Behavioral change 
method29 
Intervention components 
 
 
Active video game support 
group 
Existing/phone-based 
support group 
Task Self-
efficacy 
Modeling 
The avatar in the active video 
game and other participants in the 
group 
 
 
Set graded tasks 
Active video game (increase 
difficulty until target behavior is 
performed) 
 

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Reinforcement 
Unlocking games 
 
 
Public commitment 
Group session 
 
Barrier Self-
efficacy 
Reattribution training 
(Reinterpret previous 
failures) 
Group session   
 
 
Cue altering 
Group session  
 
Self-regulation 
Goal-setting 
Weekly log, home-based 
worksheets, group session 
 
 
Prompting self-monitoring 
Wii fit meter, weekly log (Cohorts 1 
to 3) 
Wearable fitness tracker (Cohort 
4) 
Pedometer (Cohort 1 to 
3) 
Wearable fitness 
tracker (Cohort 4) 
 
Barrier identification 
Group session 
 
 
Action planning 
Weekly log , home-based 
worksheet, and group session 
 
Motivation 
 
 
 
Autonomy 
support 
Provide information and 
provide choice 
Non-directive group discussion, 
Group game play, ACS personal 
health manager kit 
ACS personal health 
manager kit (general 
information) 
Competence 
support 
Feedback on performance 
Badges, unlocking the game, 
weekly progress chart based on 
the Wii fit meter, other participants 
in the group, and from the 
facilitator 
Pedometer 
Relatedness  
Social support 
Group play, group session, and 
identification with other survivors 
Identification with other 
survivors 
 
Social support—Emotional 
support 
Group sessions on survivorship 
issues 
Group sessions on 
survivorship issues 
 
 
Social support—Appraisal 
support 
See the “friends” progress in the 
group 
 
 
4.2 Participant Recruitment.  Participants will be recruited from Galveston county and 
surrounding counties, the University of Texas, Medical Branch (UTMB) clinics, UTMB-
associated cancer care facilities, MD Anderson clinics and from cancer or volunteer registries. 
Recruitment of MD Anderson patients will occur in person at MD Anderson and joint MD 
Anderson/UTMB clinics as well as by phone & email (following the same procedures used to 
identify UTMB patients to approach. Due to the possible difficulty of recruitment, we have 
collaborated with oncologists.  The oncologists will be referring their patients.  The team will 
not approach patients until they provided the permission for the team to approach.  For the 
other oncologists not on our protocol, a flyer will be provided to them for referral.  Participants 
will contact the researchers if interested in participating. MD Anderson personnel (Maria C. 
Swartz) will be involved in recruitment activities for the fourth cohort (Note: UTMB and MD 
Anderson have entered into an agreement such that the clinical site is a collaborative single 
site operation by both institutions.) 
 
A recruitment letter will be mailed to contact potential participants in the cancer or volunteer 
registries.  We will also collaborate with local cancer support groups.  Newspaper 
advertisement and flyers will also be used as additional recruitment tools.  We will recruit 
participants in three cohorts.  First and second cohort will consist of 10 people, 5 in the 
intervention group and 5 in the control group.  The third cohort will consist of 40 people, 20 in 
the intervention group and 20 in the control group. In order to randomize a total of 60 
participants, we will need to recruit up to 80 individuals due to drop-outs between screening 
and randomization.  The fourth cohort will consist of 20 people (age 55 and 79 to grant 

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restrictions), 10 in the intervention group and 10 in the control group. In order to randomize a 
total of 20 participants, we will need to recruit an additional 80 individuals to account for 
potential drop-outs between screening and randomization. A total of 160 individuals will be 
recruited for Cohort 1-4 in order to randomize a total of 80 participants. Screening script, 
recruitment letter, flyer, presentation blurb are presented in Appendix A. 
 
4.3 Inclusion/Exclusion Criteria. Research staff will follow the screening script to determine 
eligibility when potential participants express interest in the study.  Potential participants must 
meet all of the inclusion criteria in order to be eligible to participate in the study.   
Primary inclusion criteria will include for Cohort 1-3:   
• Provide informed consent 
• Diagnosed with primary female breast cancer  
• English-speaking between the ages of 18 years or older  
• Able to read and write in English 
• Obtained approval from oncologists for the participant to be involved in the 
physical activity based support group 
• Able to travel to the UTMB sites (Victory Lakes or Galveston) 
• Able to move arms and legs as well as ambulate 
• Able to see TV screen from a distance of 2 to 4 feet  
 
Primary inclusion criteria for Cohort 4 due to grant restrictions will include: 
• Ability to provide informed consent 
• Diagnosed with primary female breast cancer 
• 55 years to 79 
• Able to speak, read, and write in English 
• Able to travel to UTMB locations and/or MD Anderson Victory Lakes  
• Able to move arms and legs as well as ambulate 
• Has a smartphone, tablet or computer and daily access to a reliable internet 
 
Inclusion criteria for Cohort 4 due to pandemic (e.g., COVID-19) restrictions will include: 
• Ability to provide informed consent via telephone or through internet 
• Diagnosed with primary female breast cancer 
• 55 years to 79 
• Able to speak, read, and write in English 
• Able to move arms and legs as well as ambulate 
• Has a smartphone, tablet or computer and daily access to a reliable internet 
 
Potential participant meeting any of the exclusion criteria at screening will be excluded from 
study participation 
Ineligibility criteria will include: 
• Being pregnant 
• Dementia 
• Currently engage in ≥150 minutes of planned moderate physical activity per week 
for the prior week 

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• Are involved in another physical activity intervention 
 
Ineligibility criteria for Cohort 4 will include all criteria listed above. However, cohort 4 has 
an addition of no access to an internet-connected smart device (smartphone, tablet, or 
computer) being an ineligibility criterion.     
 
4.3 Randomization Procedures. Participant in cohorts 1 to 3 will be randomly assigned to 
be in the active video game-based physical activity intervention group (intervention group) or 
the existing UTMB Breast Cancer support group with pedometer (control group). Participant in 
cohort 4 will be randomly assigned to be in the weekly active video game web-based group 
sessions with wearable tracker (intervention group) or receive weekly conference calls plus 
wearable tracker (control group). We will randomize participants by using sequentially 
numbered opaque sealed envelopes for cohorts 1 to 4.  The sequentially number will be the 
Study ID #1 to #80 for cohort 1-3.A project staff who is not involved in the assessment will use 
the random number generator (https://www.randomizer.org/) to assign each study ID number 
to either intervention group or control group.  The project staff who is not involved in the 
assessment will write the group assignments will be written on pieces of paper, placed under a 
piece of carbon paper, wrapped in aluminum foil, and then sealed one per opaque envelope. 
The same procedure will be used for cohort 4.   
 
4.4 Intervention Group Procedure.  The primary purpose of this study is to investigate the 
feasibility and acceptability of active video game-based physical activity intervention among 
BC survivors within the support group setting (in person for cohorts 1-3 and over the web for 
cohort 4) with home-based components. Cohort 4 will have the addition of yellow and red 
theraputty and grip exercise to the 12-week intervention components.  The 12-week 
intervention components are presented in Table 2. Cohort 4 will not receive a Wii Fit Fitness 
tracker and we will mainly use Xbox 360 video games but may use the Wii video games. 
 
Table 2.  Summary of the 12-week Pink Warrior Program 
Week 
Cognitive-Behavioral 
skill building component  
(group and home-based 
topics) 
Activity demonstration and 
practice component 
Cancer survivorship 
discussion component 
1 
Program orientation—
distribution of the Pink 
Warrior program materials  
Topic:  Benefits of physical 
activity  
Distribute the Wii Fit fitness 
tracker 
Wii Street U:  Walking for 2 
minutes, (cohort 4 only: 
yellow theraputty, grip 
exercise) 
Review of the Personal Health 
Manager Kit and first steps for 
the newly diagnosed 
2 
Topic:  Discovering values 
and setting long-term and 
short-term activity goals 
Wii Street U:  Walking for 5 
minutes, (cohort 4: grip 
exercise 
Communicating and making 
decisions and talking to your 
doctor 
3 
Topic:  Time management 
and planning your activity 
Xbox 360:  Tai-Chi, (cohort 4 
grip exercise) 
Lymphedema 
4 
Topic:  Uncovering 
barriers 
Xbox 360:  Yoga, (cohort 4 
grip exercise) 
Finding information and 
solving problems 
5 
Topic:  Getting confident 
Wii Street U:  Walking, (cohort 
4 grip exercise)  
Symptom diary 
6 
Topic:  Finding and getting 
support 
Xbox 360:  Tai-chi, (cohort 4 
grip exercise) 
Eating well during cancer 
treatment 

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Each week will consist of both structured group sessions and self-paced home-based 
sessions. The weekly structured group session will last approximately 90 minutes. Weekly 
worksheets and participant manual will be provided to promote home-based physical activities.  
The participant manual will consist of detailed information of the weekly topic to be reviewed 
within the group setting.  Participant manual will be used for self-paced home-based materials.  
Each of the weekly sessions will consist of three components:  1) a cognitive-behavioral skill 
building component to promote the increase and maintenance of physical activity behavior, 2) 
an activity demonstration and practice component to provide guided practice and to increase 
mastery of activity skills, and 3) a cancer survivorship discussion component to provide 
support and resources for BC survivors.  Participant manual is available for review in 
Appendix B. 
 
Based on participant feedback we received from the first and second cohorts, we are 
changing the length of group sessions to 60 minutes and adding an additional healthy eating 
discussion topic.  We will also provide cancer survivorship discussion summary sheet per 
participants’ suggestions.  Updated participant manual is available in Appendix B1.  MD 
Anderson personnel (e.g., Maria C. Swartz) will be involved in cohort 4 intervention delivery 
activities.  
7 
Topic:  Problem solving 
skills: (cohort 4 distribute 
red theraputty) 
Wii Fit U:  Yoga, (cohort 4 red 
theraputty, grip exercise) 
Fatigues/Nausea and Vomiting 
8 
Topic:  Relapse prevention 
Wii Fit U:  Walking, (cohort 4 
grip exercise) 
Cancer pain 
9 
Topic:  Meaningful 
rewards 
Xbox 360:  Zumba, (cohort 4 
grip exercise) 
Negotiating and standing up 
for your rights 
10 
Topic:  Thinking about 
problems in different ways 
Wii Fit U:  Yoga, (cohort 4 grip 
exercise)   
Coping with emotional distress 
and fear 
11 
Topic:  Review of long-
term goals 
Xbox 360:  Zumba, (cohort 4 
grip exercise) 
Cancer and relationship 
12 
Topic:  Finding places you 
can be physically active in 
your community 
Wii Fit U:  Dance, (cohort 4 
grip exercise) 
Managing your health records 
13 
Certificate of achievement 
ceremony 
Celebration dance  
Healthy snacks pot luck 
Table 2.  Summary of the 12-week Pink Warrior Program 
Week 
Cognitive-Behavioral 
skill building component  
(group and home-based 
topics) 
Activity demonstration and 
practice component 
Cancer survivorship 
discussion component 
1 
Program orientation—
distribution of the Pink 
Warrior program materials  
Topic:  Benefits of physical 
activity  
Distribute the Wii Fit fitness 
tracker 
Wii Street U:  Walking for 2 
minutes, (cohort 4 only: 
yellow theraputty, grip 
exercise) 
Review of the Personal Health 
Manager Kit and first steps for 
the newly diagnosed 
2 
Topic:  Discovering values 
and setting long-term and 
short-term activity goals 
Wii Street U:  Walking for 5 
minutes, (cohort 4: grip 
exercise) 
Communicating and making 
decisions and talking to your 
doctor 
3 
Topic:  Time management 
and planning your activity 
Xbox 360:  Tai-Chi, (cohort 4: 
grip exercise) 
Lymphedema 
4 
Topic:  Uncovering 
barriers 
Xbox 360:  Yoga, (cohort 4: 
grip exercise) 
Finding information and 
solving problems 

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Within the cognitive-behavioral skill building component, the adapted Pink Warrior intervention 
content will focus on helping BC survivors overcome barriers to becoming active and to 
increase self-regulation skills. The behavior change strategies include: getting feedback 
regarding physical activity, self-monitoring, goal-setting, action planning, gaining knowledge 
regarding benefits of physical activity, and evaluation of value toward activity. We specifically 
chose these behavior change strategies because recent meta-analysis, which provided a 
comprehensive review of published physical activity programs, have shown effectiveness of 
these strategies in increasing physical activity.30 The behavioral change strategies will address 
activity barriers such as: lack of self-efficacy related to physical activity, lack of time due to 
competing demands, and lack of motivation due to general reasons or fatigue. 
 
Active video games that involve motion-controlled movement will be used for the activity 
demonstration and practice component of the Pink Warrior intervention for two reasons. First, 
they are a cost-effective way to deliver a physical activity program in the community setting 
without the need to hire an exercise trainer.31 
Second, research has shown active games 
are a unique and effective platform for 
increasing physical activity and motivation.16 
By design, active video games will produce 
enjoyment, increase self-efficacy, and 
increase motivation to increase physical 
activity through delivering evidence-based 
behavior strategies such as modeling, 
guided practice, providing instantaneous 
feedback, providing various activity options, and increases opportunity for survivors to relate to 
one another through social play.16,17 Furthermore, by wearing the Wii Fit fitness tracker in 
cohort 1-3 (Figure 2), participants will be able to track individual and group’s daily steps. They 
will also be recording their activities on a daily, weekly, and monthly basis.  Having the ability 
to see the weekly accomplishments will further enhance motivation for activity through social 
comparison and relatedness.16     
 
5 
Topic:  Getting confident 
Wii Street U:  Walking, (cohort 
4: grip exercise) 
Symptom diary and Eating well 
during cancer treatment 
6 
Topic:  Finding and getting 
support 
Xbox 360:  Tai-chi, (cohort 4: 
grip exercise) 
Healthy recipes and general 
eating plan 
7 
Topic:  Problem solving 
skills (cohort 4 distribute 
red theraputty) 
Wii Fit U:  Yoga, (cohort 4: 
red theraputty, grip exercise) 
Fatigues/Nausea and Vomiting 
8 
Topic:  Relapse prevention 
Wii Fit U:  Walking, (cohort 4: 
grip exercise) 
Cancer pain 
9 
Topic:  Meaningful 
rewards 
Xbox 360:  Zumba, (cohort 4: 
grip exercise) 
Negotiating and standing up 
for your rights 
10 
Topic:  Thinking about 
problems in different ways 
Wii Fit U:  Yoga, (cohort 4: 
grip exercise)  
Coping with emotional distress 
and fear 
11 
Topic:  Review of long-
term goals 
Xbox 360:  Zumba, (cohort 4: 
grip exercise) 
Cancer and relationship 
12 
Topic:  Finding places you 
can be physically active in 
your community 
Wii Fit U:  Dance, (cohort 4: 
grip exercise) 
Managing your health records 
13 
Certificate of achievement 
ceremony 
Celebration dance  
Healthy snacks pot luck 

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For the cancer survivorship discussion component, resources from the National Coalition 
for Cancer Survivorship’s cancer survival toolbox and American Cancer Society’s personal 
health manager kit will be used to elicit survivorship discussions.  It is the standard practice of 
the UTMB Breast Health Clinic to provide the American Cancer Society’s personal health 
manager kit to all new cancer patients.  Please see the list of contents in the personal health 
manager kit in Appendix C.  This component is designed to provide resources and support for 
the BC survivors.   
 
We will partner with stakeholders to iteratively develop and refine the Pink Warrior program. 
We plan to have half of participants receive all components of the Pink Warrior program first, 
so we can obtain and use the acceptability and feasibility information to refine the program 
before the other half of BC survivors go through the program. Furthermore, we will be able to 
compare the Pink Warrior program to the existing support group format.  
 
The fourth cohort will be a web-based AVGs group activity intervention over the 13-week 
study period. An initial in person meeting or video conference via a telemedicine platform (due 
to pandemic restrictions) will be conducted to set up weekly step goal. Participants will be 
given a wearable tracker (i.e. Fitbit) with charger and wrist band, a wearable tracker account 
with a pseudonym to use during the study period, a phone stand, and a wall charger. All of the 
pseudonym accounts will be linked to a private group on the Fitbit dashboard. The weekly 
structured group session will be conducted through a HIPPA compliant telemedicine platform 
that allows simultaneous video chat. Each session will last approximately 60 minutes 
(Appendix B2a-c. Instructions on how to use the Fitbit and how to connect to the telemedicine 
platform). The same curriculum will be used as in past cohort, refer to Table 2. Weekly 
worksheets will be provided to encourage activities outside of the group. Each of the weekly 
sessions will consist of three components:  1) a cognitive-behavioral skill building component 
to promote the increase and maintenance of physical activity behavior, 2) an activity 
demonstration and practice component to provide guided practice and to increase mastery of 
activity skills, and 3) a cancer survivorship discussion component to provide support and 
resources for BC survivors.   
By wearing the Fitbit, participants will be able to track individual and group daily steps on the 
Fitbit dashboard. Having the ability to see the weekly accomplishments will further enhance 
motivation for activity through social comparison and relatedness.16     
 
4.5 Control group procedure.   Participants in 
cohort 1-3 that are randomized to the control group will 
be introduced to the current facilitator for the existing 
Breast Cancer Support Group at the UTMB Breast 
Health and Imaging Center after the initial 
assessment.  Control group participant will be 
encouraged to participate in the Breast Cancer 
Support Group for the next 12-weeks on a monthly 
basis. Examples of topics covered in the Breast 
Cancer Support Group are presented in Appendix D.  
The support group follows the Navigating Life’s road 
Map After Breast Cancer curriculum from the 
Reconstruction of a Survivor (http://www.reconstructasurvivor.org/index.html) organization.  
Control group participant will also be provided a pedometer (Digi Walker or Omron Tri Axis HJ-

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321) to be worn for 12-weeks (Figure 3).  Participants will have a choice to use either a Digi 
Walker or Omron Tri Axis pedometer.  Participants in the control group will also receive the 
American Cancer Society’s personal health manager kit as it is standard of practice at the 
UTMB Breast Health and Imaging Center.  They will also be recording their activities on a 
daily, weekly, and monthly basis.      
 
For the fourth cohort, weekly conference calls to check on participants’ well-being and to 
provide survivorship information will be scheduled over the 13-week study period (Appendix 
B2d).  Control group participants in the cohort 4 will be given a wearable tracker with charger 
to use during the study period. A list of local breast cancer/cancer support groups will also be 
given to the participants that is available on the UTMB website. MD Anderson personnel (e.g., 
Maria C. Swartz) will be involved in cohort 4 control group activities.  
 
4.6 Measurement procedure.  The intervention includes three assessments.  Survivors will 
be provided a summary of their individual assessment results at each evaluation session 
(Appendix E).  A summary of the assessment schedule is presented in Table 3.  
Questionnaires for the self-reported measures are presented in Appendix F.  Questionnaires 
for the self-reported measures will be administered either through Assessment CenterSM 
(https://www.assessmentcenter.net/), through paper copies, or through telephone interviews 
conducted by a study staff due to pandemic restrictions. Participants will have a choice to 
complete the web-based format or the paper format.   
 
We will also obtain permission from the participants at the time of recruitment to send 
reminders.  Furthermore, prior to the 6-week and 12-week visit, a personalized email will 
provide instructions on how to access the website in a written form.  The instructions will 
include a hyperlink to the Assessment CenterSM website along with a unique personal access 
ID number.  Appendix G includes an example email to access Assessment Center.   
 
Feasibility will be evaluated through weekly attendance records, number of participants 
who completed at least 80% of the program activities including home-based worksheets, 
technological issues, and adverse events.  Observational forms and project staff logs will also 
be used to determine the ease of using the toolkit and facilitators’ ability to deliver the program 
as planned.  Participant acceptability and satisfaction will be collected at week 7 and week 12.  
Participant satisfaction will be determined based on a questionnaire with 5-point scale 
responses.  Participant will be asked to report their satisfaction with the support time and 
length, intervention materials and staff, activity demonstrations, and discussion topics. 
 
For the fourth cohort, feasibility at the implementation level include feedback on ease of 
use of the telemedicine platform, curriculum usability, ability to deliver the weekly curriculum as 
planned, and feedback on the curriculum. Feasibility measures at the participant level will 
include weekly attendance records, completion of weekly worksheets, weekly adherence to the 
intervention, number and type of technology issues, number and type/difficulty of games 
played, and adverse events. MD Anderson personnel (e.g., Maria C. Swartz) will be involved in 
the cohort 4 data collection activities.  
 
 
 
 

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Table 3a. Summary of measures and evaluation schedule (pre-pandemic restrictions) 
Measures 
Week 0 
Week 1 
Week 7 
Week 14 
Objective measures 
  SPPB to measure physical function and 
Hand grip strength test 
 
X 
X(hand grip 
strength only) 
X 
  Height, Weight, and Waist Circumference 
X 
X 
X 
X 
Actigraph wGT3X GT monitors (Physical 
activity)—cohorts 1 and 2 
X 
 
X 
X 
Actigraph GT9X monitors (Physical 
activity)—cohorts 3 and 4 
X 
 
X 
X 
Participant self-report measures 
  Demographics 
X 
 
 
X 
  Program satisfaction  
 
 
X 
X 
  CHAMPS to measure physical activity 
(cohorts 1, 2 and 4) 
X 
 
 
X 
 BRFSS physical activity questions (cohort 3) 
X 
 
 
X 
  Functional Assessment of Cancer  
  Therapy (Quality of life) 
X 
 
X 
X 
  PROMIS-Cancer Physical Function 
X 
 
 
X 
  PROMIS-Cancer Fatigue 
X 
 
 
X 
  Dietary screener/recall 
X 
 
 
X 
Psychosocial variables related to exercise 
  Exercise motivation 
X 
 
X 
X 
  Psychological Feelings 
X 
 
X 
X 
  Self-regulation  
X 
 
X 
X 
  Social support 
X 
 
X 
X 
  Task and Barrier Self-efficacy  
X 
 
X 
X 
  Posttraumatic Growth Inventory-SF (cohort 
3) 
X 
 
X 
X 
 
Table 3b. Summary of measures and evaluation schedule (during and post pandemic restrictions) 
Measures 
Week 0 
Week 1 
Week 7 
Week 14 
Objective measures 
  SPPB and 2-minute step test to measure 
physical function  (virtual) 
 
X 
X 
X 
  Height, Weight, and Waist Circumference 
X 
X 
X 
X 
Actigraph wGT3X GT monitors (Physical 
activity)—cohorts 1 and 2 
X 
 
X 
X 
Actigraph GT9X monitors (Physical activity)—
cohorts 3 and 4 
X 
 
X 
X 
Participant self-report measures 
  Demographics 
X 
 
 
X 
  Program satisfaction  
 
 
X 
X 
  CHAMPS to measure physical activity (cohorts 
1, 2 and 4) 
X 
 
 
X 
 BRFSS physical activity questions (cohort 3) 
X 
 
 
X 
  Functional Assessment of Cancer  
  Therapy (Quality of life) 
X 
 
X 
X 
  PROMIS-Cancer Physical Function 
X 
 
 
X 
  PROMIS-Cancer Fatigue 
X 
 
 
X 
  Dietary screener/recall 
X 
 
 
X 
Hand Scale 
 
X 
X 
X 
FRAIL index 
 
X 
 
X 
Insomnia Severity Index 
X 
 
X 
X 
Psychosocial variables related to exercise 
  Exercise motivation 
X 
 
X 
X 

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  Psychological Feelings 
X 
 
X 
X 
  Self-regulation  
X 
 
X 
X 
  Social support 
X 
 
X 
X 
  Task and Barrier Self-efficacy  
X 
 
X 
X 
  Posttraumatic Growth Inventory-SF (cohort 3) 
X 
 
X 
X 
 
 
Participants will also be asked to report their intention to continue using the program material, 
appropriateness of the program in meeting their needs, and actual use of the Wii Fit 
pedometer or Digi-walker/ Omron Tri Axis pedometer. Feasibility information, participant 
satisfaction will be used to refine the intervention and also help us refine the tools we have 
developed for implementation of the Pink Warrior intervention within the clinic and community 
settings. 
 
The changes in physical activity level among breast cancer survivors who were randomized 
into the Pink Warrior intervention or into the existing UTMB breast cancer support group with 
pedometer will be evaluated at baseline and at week 14.  Physical activity changes such as 
meeting the recommended 150 minutes per week or 7,000-10,000 steps/day will be measured 
by Actigraph wGT3X BT monitors. Wear time will be seven days at each assessment point. 
Because continuous measurement is not feasible, a week-long sample will be taken at 
baseline, week 7(+/- one week) and week 14(+/- one week). Physical activity estimates will 
only be considered as valid if the monitor is worn ≥ 10 hours per day on ≥ 4 days.  Also 
through the community healthy activities model program for seniors (CHAMPS) self-reported 
questionnaire at baseline and at week 14 will be administered for participants in cohorts 1, 2, 
and 4.  The changes in dietary pattern will be evaluated using the Dietary Screener 
Questionnaire used in the National Health and Nutrition Examination Survey 2009-10.  The 
screener captures frequency of fruits, vegetables, dairy/calcium, added sugar, 
wholegrains/fiber, red meat, and processed meat consumption within the past 30 days.32 
Health related quality of life outcomes will be measured by using the Functional Assessment of 
Cancer Therapy and Patient reported Outcomes Measurement information System (PROMIS) 
adapted testing.33 
For the third and fourth cohort we will measure physical activity changes (e.g., 150 minutes per 
week of activity or 7,000-10,000 steps/day) by using Actigraph GT9X to accommodate the 
increased number of participants in cohort three and four. Based on participant feedback from 
cohorts 1 and 2, we also removed the CHAMPS self-reported questionnaire for the third cohort 
to reduce participant burden. Instead, we are adding eight questions from the 2015 Behavioral 
Risk Factor Surveillance System (BRFSS) questionnaire to the main demographic 
questionnaire.  
 
Physical function and physical changes will be objectively measured. The Short Physical 
Performance Battery (SPPB) will be used to objectively measure physical function for cohorts 
1 and 2. The battery consists of six components:  repeated chair sit and stands, balance test, 
semi-tandem stand, tandem stand, side-by-side stand, and eight feet walk (Appendix H).34  
The hand grip strength test is used to measure changes in physical strength.35  For cohort 4 
we added hand grip strengthening exercises using theraputty and home-based exercises due 
to low normative scores we found from cohorts 1 and 2. Grip strength will be measured using a 

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Dynamometer.  Based on possible ceiling effect we found in cohorts 1 and 2, we are going to 
use the Senior Fitness Test36 along with two subsections of the SPPB protocol—balance with 
time increase to 30 seconds and timed 3 meter usual walk and fastest walk.  Senior Fitness 
Test consist of six different components:  1) chair stand test (evaluate lower body strength), 2) 
arm curl test (evaluate upper body strength), 3) chair sit and reach test (evaluate lower body 
flexibility), 4) back scratch test (evaluate upper body flexibility), 5) 8-foot up and go test 
(evaluate agility), and 6) 2-minute step in place test (evaluate aerobic endurance).  We are 
also adding the Figure-of-8 Walk test to evaluate walking skills in daily life (Appendix H1).37   
 
For Cohort 4, we implemented several pandemic-related changes to the physical function 
measures. We have chosen to make the following changes to maintain the integrity of the 
physical function data being collected due to the pandemic restrictions (Table 4). 
Table 4. Summary of changes due to pandemic restrictions 
Type of assessment 
Pre-pandemic 
During and post pandemic 
SPPB 
In-person 
Via Video conference  
Grip strength 
In-person 
The Cochin Hand Scale38 (self-
report, but collected through 
interview) 
SFT 
In-person 
Collect 2-minute step in place and 
Timed Up and Go components via 
video conference. All other 
components will not be collected 
because we cannot adjust our 
protocol safely.  
 
Fatigue, Resistance, Ambulation, 
Illness, Loss of Weight (FRAIL) 
index39 (self-report, but collected 
through interview) 
Figure-of-8 Walk test  
In-person 
Will not be conducted 
 
Due to equipment limitations during the pandemic, we will not be able to use a hand 
dynamometer to assess the hand grip strength objectively. We chose the Cochin Hand Scale 
instead to capture self-report daily hand function. This measure will be administered by a 
research coordinator/interviewer. The scale consists of 18 items with a 6-point Likert response 
that ranged from 0 (Yes, without difficulty) to 5 (Impossible to do). The Cochin scale had an 
inter-rater reliability of 0.96.38    
Due to safety concerns and possible space and equipment limitations, we have limited the SFT 
test to only the Timed Up and Go (TUG) and 2-minute step test. Participants will be mailed an 
enrollment packet that consists of a tape measure and colored tape to measure out the 
walking course for SPPB, TUG, and the 2-minute step test. We added the FRAIL index 
measure to capture an additional physical function measure. FRAIL is a self-report functional 
measure that will be administered by a research coordinator/interviewer. The FRAIL index 
consisted of questions in 5 components—fatigue, resistance, ambulation, illness, and loss of 
weight. Frail scale scores can range from 0 (best) to 5 (worst). A score of 3 to 5 is categorized 
as frail, a score of 1-2 is categorized as pre-frail, and 0 is considered as no frailty and pre-
frail.39  Given the possible increase in psychosocial stress with the current pandemic and its 
negative impact on sleep, we added a sleep measure that will evaluate the impact of our 

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intervention on sleep. The Insomnia Severity Index (ISI) is a 7-item validated self-report scale 
that assesses subjective symptoms of insomnia. Items are scored on a 0-4 scale to yield a 
score of 0-28. Higher scores indicate greater insomnia severity. A cutoff score of ≥ 10 is 
optimal to detect clinical levels of insomnia. It is also sensitive to change over time.40 A change 
score of -8.4 points is associated with moderate improvement.40   
 
Other self-reported measures include demographics such as age, gender, race/ethnicity, 
education, type of cancer diagnosis, and the type of treatment the participant is receiving.  
Exercise motivation will be evaluated by using the Behavioral Regulation in Exercise 
Questionnaire-2 to assess participants’ motivation towards physical activity (intrinsic, identified, 
introjected, or extrinsic).  The questionnaire had an alpha ranged between 0.73-0.86.41 
Psychological feelings about exercise will be evaluated by using the Psychological Need 
Satisfaction in Exercise Scale to assess participants’ perceived competence, perceived 
autonomy, and perceived relatedness.  The questionnaire had an alpha >0.90.42  The self-
regulation will be evaluated by using the Rovinak et al. scale that assess participants’ exercise 
goals and exercise plans.  The questionnaire had an alpha raged from 0.87 to 0.89.43  Self-
efficacy will be evaluated by using the Rogers et al. scale. That assess participants’ self-
efficacy to over barriers and their task related self-efficacy.  The questionnaire had an alpha 
ranged from 0.89 to 0.96.44  We added a 10-question Posttraumatic Growth Inventory-Short 
Form (PTGI-SF) to capture positive psychosocial changes that developed after facing 
challenging life circumstances (i.e., cancer diagnosis and treatment).45  The questionnaire had 
an alpha of 0.93 among cancer patients.  Furthermore, we added The Physical Activity Group 
Environment Questionnaire (PAGEQ) for cohort 4. PAGEQ is a 21-item questionnaire on a 9-
point Likert scale that ranged from “strongly agree” to strongly disagree.” The questionnaire 
has an alpha ranged from 0.65 to 0.94. PAGEQ was added because it can influence 
attendance, timeliness, improve attitude towards PA, and stronger PA self-efficacy. 
Participants will not receive any monetary incentive (cohort 1-3). Rather, a water bottle and a 
tote bag will be provided to both intervention and control group participants as a thank 
you/token of appreciation for participating in the study.   
 
4.7 Unscheduled visits/communication. We will download the activity monitor 
information during Assessment 1. If monitor activity was worn less than 10 hours per day for 4 
days we will ask the participant to wear the activity monitor for 7 more days and reschedule 
randomization only. Some participants may attend an additional visit for randomization if we do 
not have a valid physical activity measurement. We may also contact participants via phone, 
text, or email to schedule appointments, the day before an appointment as a reminder, and if 
we have a question or concern regarding their participation such as following up on 
questionnaire responses or adverse events. Additional calls/texts/emails may occur to 
schedule accelerometer drop off prior to week 14 assessments. After hours texts or calls will 
only occur if pre-arranged for the purposes of picking up study materials. Text messages are 
optional. Message and data rates may apply. Any in-person contact that occurs to drop off an 
accelerometer will be minimal and only for the purposes of providing the monitor and 
instructions for its wear. If we encounter any technical difficulties with the study material we will 
troubleshoot the equipment. Once the equipment is ready we will contact you to mail/drop off 
or set up a meeting to provide the study material. We will be available by email and phone for 
technical consultation. We will allow up to one in-person meeting for technical support. We will 
reply to texts/emails/phone calls during business hours for technical problems or to schedule 
calls/assessments. After hours texts or calls will only occur if pre-arranged for the purposes of 

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picking up study materials. 
  
4.8 Participant compensation (cohort 4). Participants will be compensated for the parking fee 
via parking validation. Due to funding restrictions, cohorts 1-3 were not provided monetary 
compensation for participation. However, cohort 4 participants will be provided gift cards 
totaling $15 ($5.00 at baseline, $5.00 at midpoint, and $5.00 at the final visit).A water bottle 
and a tote bag will be provided to both intervention and control group participants as a thank 
you/token of appreciation for participating in the study.   
 
 
5.0 Potential Risk to Participants  
• Confidentiality could be breached, as is a risk in all human subjects research.  
Sensitive personal health information or other sensitive information could be 
divulged inappropriately to outside sources. 
• Physical functioning testing.  Short Physical Performance Battery and hand grip 
strength testing may involve minimal risk.  Risks include muscle soreness, fatigue, 
and potential muscle strain.     
• Injury, pain or fatigue.  Participants may experience joint discomfort, muscle 
soreness, or other minor injuries due to increased physical activity. Cohort 4 the 
addition of possible skin irritation or other minor injuries due to increased physical 
activity and the use of theraputty. 
• Activity monitors such as the Actigraph, Wii Fit meter, and Digit-Walker pedometer, 
cohort 4 the use of Fitbit or Mi Xiaomi Band 3 are associated with minimal risk.  
Some participants might feel slight discomfort or skin irritation from the monitors’ 
contact with the skin.   
• Embarrassment.  Participants may feel embarrassed to share their activity 
information with other participants. 
We believe all identified risks are minimal given the proposed procedures for protecting against 
risk. 
5.1 Protection Against Potential Risks.  All study personnel have attended required courses 
on human subject protection and HIPAA regulations, and certificates of Institutional Review 
Board training completion are on file at UTMB.  Participants that are eligible based on initial 
screening will be invited to attend an initial session.  They will be given a group orientation to 
the study, including information on all aspects of the study from the principal investigator (PI).  
They will be able to ask questions at any time.  Following this explanation, potential 
participants will be given informed consent information and forms to sign.  After completing this 
information, they will proceed to the baseline assessment.   
•  Confidentiality All data collected will remain confidential.   
o Paper copies of screening forms and assessment forms will be kept in a 
locked file cabinet in the PI’s locked office.  ID numbers will be used on these 
forms to match them to individual participants.  The database matching ID 
numbers to identifying information will be individually password-protected and 
kept separately on the UTMB secured server.   
o As for the web-based questionnaire administered through Assessment 

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CenterSM, the security statement indicated that the Assessment CenterSM 
uses role-based permissions that restrict access to participant data and the 
privacy of data is driven by HIPAA requirements.  The Assessment CenterSM 
is maintained and secured at Northwestern University Research Data Center 
in Chicago, IL.  Detail description of the security measure is described in 
Appendix H. Briefly, the Northwestern University Research Data Center have 
secure communication lines in place to prevent the interception of data 
transmission by utilizing various data encryption technologies (i.e. Secured 
Socket Layer) and digital certificates; signatures may also be used to encrypt 
data, validate data integrity, and authenticate the parties in a transaction.  The 
protected health information (PHI) will be stored separately from other survey 
data.  In addition, the PHI will only be collected and transferred only when 
necessary.  Any data that needs to be transferred will be encrypted prior to 
transfer.  All of the participants will be identified by a generic ID generated by 
the Assessment CenterSM.  Furthermore, the Northwestern University 
Research Data Center has an established infrastructure for confidential data 
management that includes having secured facilities that are being monitored 
24x7, has sophisticated use of firewall technologies, has intrusion detection 
software, has anti-virus scans, has dedicated database and application 
servers, has automatic failover design, has real-time monitoring and related 
technological capabilities.  It also is fitted with redundancy for HVAC, power, 
and fire detection/suppression systems (Appendix I).    
o The web-based questionnaire will not ask for participant’s name. The research 
staff will provide each participant a unique study identification number.  All 
necessary firewall and password protections will be implemented to store 
electronic files.  The internet will be used to transfer the completed survey from 
the Assessment CenterSM with study ID to UTMB secured network.  The data 
will also be stored and formatted using SPSS for Windows (version 20) on the 
secured UTMB network that requires unique username and password. 
o Activity monitors will be encrypted to prevent unauthorized viewing of the 
application data.  Participants in the intervention group will be “friends” with 
one another.  Participants will use pseudonyms on the Wii U and Xbox 360 
systems, and wearable trackers to provide additional layer of security.  All 
information collected by the Wii Fit meter, wearable trackers, or the Digit-
Walker will be generic and related to physical activity—no other health 
information will be collected on these devices. 
o Telemedicine platform and the conference call systems are HIPPA compliant 
(Appendix J). 
• Physical functioning testing.  Short Physical Performance Battery (cohorts 1 and 2) 
and Senior Fitness Test (cohort 3 and 4) and hand grip strength testing will occur at 
the UTMB sites with trained nursing staff nearby and will be performed by a 
research coordinator trained in conducting physical assessments.  The location of 
the tests and supervision by medical personnel will ensure that, in the unlikely but 
possible case of injury, treatment will be immediately available.   
• Injury, pain or fatigue.  Walking and low impact activity that will be performed via Wii 
U and Xbox 360 system, and performing grip strengthening using theraputty and 
home-based exercise may produce minor injuries.  We will reduce the risks for such 
events by providing detailed protocols and instructions that increase in difficulty 
slowly over time and that include adequate warm-up and cool-down. The home-

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based grip strengthening is not contraindicated for use with breast cancer survivors. 
An Occupational Therapist will oversee and provide instructions to participants.  
During the weekly session, study staff will inquire about the participants’ walking 
plans and how participants feel during exercise.  Immediate steps will be taken if 
there is any indication of potential adverse events.  (see data safety and monitoring 
plan).     
• Activity monitors.  We will warn participants of the risk of potential skin irritation due 
to wearing the measurement equipment and using theraputty.  We will also provide 
participants with several alternative procedures that could be used to minimize 
discomfort, such as inserting a soft cloth between the monitor and the skin and 
alternative exercises for gripping.   
• Embarrassment.  We will provide training and discussion during the orientation on 
the importance of confidentiality and privacy.  All participants will use pseudonyms 
when logged into the Wii U system to ensure that their activity information cannot 
be connected to their true identity. 
5.2 Potential Benefits of the Proposed Research.  Physical activity interventions may 
improve mood, fatigue, and overall health. 
5.3 Importance of Knowledge to be Gained.  There is a need for better understanding of 
strategies for increasing physical activity among breast cancer survivors.  Successful 
intervention on these behaviors could have a large positive public health impact.  If effective, 
implementing the physical activity intervention using commercially available active games are 
scalable for wide dissemination to other breast cancer support groups. 
6.0 Study Withdrawal/Discontinuation 
A study participant will be discontinued from participation in the study if any of the following 
occur: 
• Serious adverse event (SAE)  
• Medical condition or situation occurs that prohibits the participant to participate in 
intervention activities and would not be in the best interest of the subject in the 
opinion of the PI/treating medical staff 
• Participant withdraws consent to continue in the research for any reason 
 
6.1 Handling of Withdrawals.  If participants withdraw from the study because of an SAE 
they will receive a follow up phone call by study personnel to collect safety data.  If voluntary 
withdrawal occurs, study personnel will attempt to contact the participant for return of study 
equipment. 
6.2 Termination of Study.  This is a low risk study.  We cannot foresee any reason to 
terminate the research.  Individual participants will be discontinued from the protocol if they 
develop serious medical or psychiatric symptoms that necessitate their removal from the study.  
In such cases participants will be referred to appropriate care in their community. 
 
7.0 Statistical Considerations 
 
This is a pilot randomized controlled trial comparing the support group using active video 
game-based physical activity intervention to the existing UTMB breast cancer support group 

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with pedometer.  We will measure feasibility and acceptability-related process measures and 
outcome measures.  MD Anderson personnel (Maria C. Swartz) will lead the cohorts 1-4 data 
analyses and manuscript development. Data provided to MD Anderson personnel for data 
analyses will be de-identified.  
 
Aim 1:  Evaluate the feasibility and acceptability of active video game-based physical 
activity intervention among BC survivors within the support group setting.  Feasibility 
findings will be based on descriptive analyses.  We will compare our summary results to other 
studies.  Examples of feasibility findings include: number of completed home-based 
worksheets, number of participant attendance on a weekly basis, number of participants who 
completed the program and the program activities, and weekly step goal achieved.  Adherence 
is considered as a feasibility outcome.  Weekly adherence is defined as the participant wearing 
Wii Fit meter for ≥ 5 days and attend at least 10 group sessions. 
 
 
Aim 2:  Compare the support group using the active video game-based physical activity 
intervention (intervention group) to the existing UTMB breast cancer support group with 
pedometer (control group for cohorts 1-3) or the telephone-based support group with 
the UTMB support group (control group for cohort 4).  We will use analysis of covariance 
(ANCOVA) to test the post-intervention differences at 12-weeks (physical activity) between the 
two groups, controlling for baseline and other covariates that are significantly different at 
baseline.  Intent to treat analysis will be used to handle missing data.  ANCOVA will also be 
used to evaluate the secondary outcomes (physical function and quality of life).  We will 
explore the changes in psychosocial variables using linear mixed models to investigate 
differences between groups and over here time points.  Since this is a pilot study and it is not 
powered to detect significant differences of small to moderate effects, we hypothesized that 
the intervention group will show an improvement in physical activity, physical function, and 
quality of life compared to the control group.  We also hypothesize that the intervention group 
will show an improvement in self-reported scores on self-efficacy, self-regulation, intrinsic 
motivation  
 
Aim 3: Develop tools for implementation of the Pink Warrior intervention within the 
clinic and community settings. Development of a trainer’s manual for the intervention will 
mainly be based on descriptive analyses using the facilitator’s weekly group log.  The 
facilitators will indicate whether or not they were able to cover the entire session as planned 
and facilitator will also be asked to provide feedback regarding the facilitator’s guide and their 
feedback regarding the group activities.   
 
7.1 Sample Size Calculation.  The primary purpose of this study is to evaluate the feasibility 
of intervention components and study procedures to inform a larger intervention trial.  This is a 
necessary research that is related to research focused on cancer survivors.  For these 
reasons, a sample size of 60 is deemed appropriate to test intervention.  A sample size of 60 is 
enough to detect an increase in 1000 to 2000 steps from baseline to follow-up based on other 
published pedometer-based interventions.46,47 We will use our findings from this pilot study to 
establish effect sizes and inform the power and sample size estimates for larger trials. In the 
fourth cohort, a sample size of 20 is deemed appropriate to determine the Cohen’s d effect 
sizes the intervention has on activity level (average number of steps/day), physical function, 
and self-reported quality of life.  
 
8.0 Potential Difficulties and Limitations 

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8.1 Potential Difficulties.  Our intervention involves human subjects and technologies, which 
may result in a number of potential difficulties.  Study results may be affected by adherence 
among participants.  However, preliminary study by our lab suggested that most participants 
will be compliant and one of the feasibility outcome is adherence.  Technology issues may 
arise throughout the intervention.  Technology issues may include, but not limited to, the Wii Fit 
meter or Digit-Walker malfunctioning or the Wii Fit meter syncing issue, or issues with the Wii 
U or Xbox 360 consoles.  To address possible technology issues, the facilitator and the project 
staff will be available to help participant problem solve technology issues at the weekly session 
or will be available by phone.  Participants will be urged to contact the research staff if 
problems arise and defective monitors will be replaced.    
 
8.2 Limitations.  The Pink Warrior intervention does involve a more extensive facilitator 
training than the current support group format.  Therefore, time for facilitator training may be an 
issue for future implementations.  However, if the study proves feasible, then subsequent study 
will be conducted to evaluate how to efficiently deliver facilitator training.  In addition, this study 
is also limited to the greater Galveston, TX community.  Even though our pilot results may not 
be nationally generalizable, we will use our results to inform the design of a larger and 
generalizable study. 
 
9.0 Ethics and Protection of Human Subjects 
Potential participants will be provided with an in-depth informed consent information prior to 
baseline assessments, being randomized, and beginning of study participation.  The principal 
investigator (PI) or research staff will outline pertinent information and go over the consent 
form with each individual.  All study personnel will be trained in the conduct of human research 
and only individuals authorized by the PI will have access to data on a need to know basis.    
Extensive discussion of risks and possible benefits of participation will be provided to the 
potential participant.  Consent forms describing in details the study procedures and risks will 
be IRB-approved and the potential participant will be asked to read and review the document.  
Upon reviewing the document, the investigator or staff will explain the research study to the 
potential participant and answer any questions that may arise.  Potential participant will then 
sign the informed consent document prior to any study procedures.  The potential participants 
will also have the opportunity to think about it prior to agreeing to participate.   
Participants may withdraw consent at any time throughout the course of the trial.  A copy of 
the informed consent document will be given to the participant for their records.  The rights and 
welfare of the participants will be protected by emphasizing to them that the quality of their 
medical care will not be adversely affected if they decline to participate in this study.     
We anticipate this study to present minimal risk depending on the age of the participant.  
Risks include breaches of confidentiality and acute musculoskeletal injuries (muscle soreness, 
sprains, skin irritation, sunburn).  We have sought to minimize the risk by obtaining approval 
from their treating oncologist prior to participation.  If participants follow the activity 
recommended by the program there should be no unintended consequences, but serious 
injuries may arise as a result of vigorous physical activity.  In this event, the necessary actions 
defined by the IRB will be taken.     
The design of this randomized controlled trial to include the control group is to assist the 
research team compare the different interventions.  Participants in the control group still 

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receives a standard intervention with a basic pedometer.  Despite randomization, participants 
in the control group will be offered the participant manual at the end of the intervention.   
 
9.0 Data and Safety Monitoring Plan 
 
The PI Dr. Elizabeth Lyons will make up the study safety team and oversee all participant 
safety and data monitoring.  The PI is responsible for monitoring procedures during conduct of 
the study for each participant including:  eligibility, enrollment, data collection, evaluation of 
study outcomes, problems with informed consent, and participant safety and well-being.  Dr. 
Lyons will be the point of contact for all study-related personnel who come into contact with 
and monitoring the safety of research participants. An Occupational Therapist will oversee grip 
strengthening exercises, home exercise worksheets, and will be responsible for modification of 
activity.  All study personnel will be responsible for monitoring for any potential adverse events 
or negative reactions.  The coordinator will be the point of contact for study participants and 
will assess for all safety concerns, make necessary inquiries with participants, and document 
all potential adverse events.   
The plan for monitoring will include: 
1. Regular review of screening call logs by PI 
2. Regular review of group session logs by PI 
3. Regular review of collected data performed by PI and investigator team 
4. Annual review by PI  and UTMB IRB 
Review of screening call logs on a regular basis will ensure that any values indicating 
ineligibility and/or unsafe practices are flagged.  Flagged participants may be excused from the 
study or instructed on safer practices as needed.  Group session logs completed by the 
facilitator and project staff will also be reviewed by the PI.  Any indication of an adverse event 
or unsafe practices will also be flagged.  In the case of adverse events, stand protocol for 
reported adverse events will be used.  Study data will be reviewed by the PI and investigator 
team.  Again, the team will identify any values indicating unsafe practices or potential adverse 
events that may not have been reported by participants.  Finally, the UTMB IRB will review 
study progress yearly.   
 
As this is a low-risk study, we do not anticipate any serious adverse events or safety 
concerns.  Thus, we will not perform full statistical analysis during these periodic reviews.  
Though we anticipate possible differences in health outcomes, for the study to be rigorous, we 
must continue to measure all planned variables at each planned time point.  The reviews will 
focus on indicators of safety for participants, such as large decreases in quality of life or 
strength, or large weight gains.  We will create a list of a priori criteria for quantifying clinically 
significant change based on adverse events information published by the NCI.  (For example, 
a weight gain of 5-10% would be considered a mild adverse event.)   
 
We will not convene an external Data Safety and Monitoring Board. 
 
Anticipated non-serious adverse events include musculoskeletal pain or mild injuries, other 
non-serious injuries (e.g., bruises), skin irritation, minor discomfort, cardiac events, fatigue, 
weight gain, and possible loss of confidentiality. If an anticipated adverse event occurs, the PI 
will immediately confer regarding each event. The attribution and impact of each event on the 

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overall project’s risk/benefit ratio will then be determined. 
 
All unanticipated, serious, fatal, and/or life-threatening adverse events will be immediately 
reported to the UTMB IRB within 24 hours of occurrence.  The IRB and PI are responsible for 
determining if modifications are needed to the consent form and/or protocol based on the 
event. If a determination is made that participants are exposed to unacceptably high risk in 
comparison to benefit, the study will be suspended until proper modifications are made for 
participant safety. Aggregate reports of adverse events will be prepared in consultation with 
the regulatory key resource of the Institute for Translational Sciences at UTMB and forwarded 
to the IRB for review. 
 
9.1 Plan for data management. For self-report and feasibility data, the PI is responsible for 
collection and storage of data initially on electronic questionnaires and saved assessment 
information from the paper format, then transferred to a computer database located on a 
secure UTMB server.  Questionnaire data will not be personally identifiable. All questionnaires 
will use ID numbers for identification purposes, and the correspondence of ID numbers to 
names will be kept in a password-protected file on a password-protected, secure server. 
Databases will use ID numbers for identification of data and will also be stored on the secure, 
password-protected server.  The data collected by the game consoles will not be directly linked 
to the participants because pseudonyms were provided for each participant.  Data saved by 
the game consoles will be moved and erased form the console prior to further use of the 
console or provision to another participant. 
 
9.2 Plan for adverse event reporting. The PI will also hold responsibility for monitoring and 
reporting adverse events of any kind. We do not anticipate severe adverse events, though mild 
and moderate events are possible. The scale to be used is the UTMB Clinical Research 
Center Adverse Event Grading Scale (Table 5). Examples of each level of adverse event on 
the scale are provided below.  
• Mild events include discomfort without disruption of daily activities. No therapy or only 
symptomatic therapy is required. This level is equivalent to NCI Common Terminology 
Criteria for Adverse Events version 4.03 Grade 1 adverse events (mild; asymptomatic or 
mild symptoms; intervention not indicated). 
• Moderate events include discomfort sufficient to modify daily normal activity. Specific 
therapy is required. Laboratory test alterations indicate injury without long-term risk. 
This level is equivalent to NCI Grade 2 (moderate; minimal, local or noninvasive 
intervention indicated; limiting age-appropriate activities of daily living). 
• Severe events include incapacity, inability to work, inability to perform normal daily 
activity, hospitalization required, prolonged emergency treatment required, life-
threatening events, laboratory tests indicating a serious health threat or permanent 
injury, and death. This level is equivalent to NCI Grades 3 (severe/medically significant 
but not immediately life-threatening), 4 (life-threatening, urgent intervention indicated), 
and 5 (death). 
 
Table 5. Reporting of adverse events to IRB  
NCI Adverse Event Grade 
Expected 
Unexpected 
Grade 1 
Reporting not required 
Report within 10 days 
Grade 2 
Reporting not required 
Report within 10 days 
Grade 3 (UTMB level 3) 
Report by phone within 24 hours 
Report by phone within 24 hours 
Grade 4 (UTMB level 3) 
Report by phone within 24 hours 
Report by phone within 24 hours 
Grade 5 (UTMB level 3) 
Report by phone within 24 hours 
Report by phone within 24 hours 

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The PI will follow the reporting requirements for serious and unexpected adverse events 
outlined in the UTMB IRB Adverse Event Policy. All unanticipated, serious, fatal, and/or life-
threatening adverse events will be reported to the UTMB IRB within 24 hours of occurrence or 
recognition. Aggregate reports of adverse events will be prepared on an annual basis and 
forwarded to the IRB at annual review. 
 
Attribution will be assessed by the PI on a scale used by CRC investigators: 1) not related, 2) 
possibly related, 3) probably related, 4) definitely related to the study interventions. 
 
9.3 Protection of human research participants – computer-based training. All research 
personnel have completed the UTMB required training course in protection of human research 
participants. 
 
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12.0 List of Appendices 
Appendix A.  Screening script, recruitment letter, recruitment flyer, and presentation blurb 
Appendix B.  Participant Manual 
Appendix C.  American Cancer Society’s Personal Health Manager Kit Content 
Appendix D.  UTMB Breast Cancer Support Group Topics 
Appendix E.  Assessment Summary Sheet 
Appendix F.  Questionnaires 
Appendix G.  Email Template for the Assessment Center   
Appendix H.  SPPB Protocol 
 
 
H1. Senior Fitness Test Manual 
Appendix I.    Assessment Center Security Information 
Appendix J.  HIPPA Compliance information