Pink Warrior 2: Teleconference-based Gaming Support

Study Overview
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Brief Summary
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Breast cancer survivors, from diagnosis until the end of life, go through many transitions. One major transition is the significant decrease of physical activity immediately after diagnosis. Despite the known benefits of physical activity-speeding recovery time and reduced cancer recurrence risk-only 1 in 3 survivors met physical activity recommendations of 150 minutes of moderate-intensity activity per week. Physical activity interventions have shown effectiveness in helping breast cancer survivors increase physical activity during treatment, but limited evidence-based physical activity interventions have been incorporated into the clinic and community. To address this limitation, the investigators are partnering with the UTMB breast cancer support group to conduct a 12-week physical activity intervention, Pink Warrior. The goal of this study is to compare an intervention that uses active games versus an intervention uses pedometer to encourage physical activity such as walking within breast cancer survivors in active cancer treatment. The study will include breast cancer survivor between the ages of 18 - 70 whom currently gets less than 150 minutes of planned physical activity per week and received a breast cancer diagnosis within 0 to 6 months. Participants will be randomized to participate in the support group using the active video game-based physical activity intervention (Wii and Xbox active games) or to participate in the existing UTMB breast cancer support group with pedometers (Digi-Walker CW-700/701). The investigators hypothesize that by engaging in active video gaming, breast cancer survivors will be motivated to initiate and maintain physical activity during treatment. This will ultimately increase functional capacity and prevent functional disability in breast cancer survivors.

Detailed Description
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Increasing and maintaining physical activity among female breast cancer (BC) survivors during treatment remains an unresolved problem in BC survivorship care. 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 physical activity-speeding recovery time and reduced cancer recurrence risk-less than 30% of survivors met physical activity recommendations. Physical activity interventions have shown effectiveness in helping BC survivors increase activity during treatment, but limited evidence-based activity interventions have been disseminated into the clinic and community. To address this limitation, we are partnering with the UTMB breast cancer support group to conduct a 12-week physical activity intervention, Pink Warrior, which will investigate the feasibility of implementing active video game-based physical activity intervention among BC survivors undergoing treatment within the support group setting. 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. Our specific aims are: Aim 1: Evaluate the feasibility and acceptability of active video game-based physical activity intervention among BC survivors undergoing treatment within the support group setting. Measures of feasibility will include weekly attendance records, number of completed home-based worksheets, 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 the existing UTMB breast cancer support group with pedometer. 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.

Official Title
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Pink Warrior 2.0: Teleconference Support Group Toolkit for Breast Cancer Survivors

Conditions
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Breast Cancer, Physical Activity

Intervention / Treatment
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* Behavioral: Active video game teleconference support group
* Behavioral: Standard support group + pedometer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 les as well as ambulate Has a smartphone, tablet or computer and daily access to a reliable internet Exclusion Criteria: Pregnancy Diagnosed dementia Currently engage in 150 minutes or more of planned moderate intensity physical activity Currently involved in another physical activity intervention

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active video game teleconference support group<br>Participants will attend enhanced support group meetings via zoom teleconferencing software. Support group meetings will include group play of active video games and discussion of survivorship topics. Participants will self-monitor physical activity using Fitbit wearable activity monitors and will receive a water bottle and tote bag. | Behavioral: Active video game teleconference support group<br>* 12 sessions of teleconferenced support group meetings, including active video game play + self-paced walking monitored by Fitbit wearable device<br>|
| Active Comparator: Standard support group + pedometer<br>Participants will attend standard in-person support groups currently offered by the UTMB Breast Health Center. They will also receive a standard pedometer and a water bottle and tote bag. | Behavioral: Standard support group + pedometer<br>* 3 monthly sessions of in-person standard support group meetings + self-paced walking monitored by pedometer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Walking Physical Activity as Measured by Change in Daily Steps From Baseline to 14 Weeks | Difference in mean of daily steps taken from Actigraph accelerometer worn for 7 day period from baseline assessment to 14 week assessment | Baseline to 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life as Measured by the Change in FACT-B Scores From Baseline to 14 Weeks | Quality of life score as measured by the Functional Assessment of Cancer Therapy-Breast measure at follow-up, scored for physical, social, emotional, functional, and breast well-being (here we report the total score of these subscales). The range for this scale is 0-123, with 0 indicating a better outcome. | Baseline to 14 weeks | 
| Physical Performance as Measured by the Change in Short Physical Performance Battery Scores From Baseline to 14 Weeks | Difference in physical performance as measured by Short Physical Performance Battery from baseline to 14 weeks. The numbers reported here are the sum of scores from the subscales. The range for this measure is between 0-12, with lower scores indicating better outcomes. | Baseline to 14 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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active video game, telemedicine, cancer survivor, women's health, support group, survivorship, mhealth