Pink Warrior-Support Group Toolkit for Breast Cancer Survivors

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.

Official Title
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Pink Warrior-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-based intervention
* Behavioral: Pedometer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provide informed consent Diagnosed with primary female breast cancer within 0 to 6 months period of time English-speaking between the ages of 18 and 70 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 Breast Health Center Able to move arms and legs as well as ambulate Able to see TV screen from a distance of 2 to 4 feet Exclusion Criteria: Being pregnant Dementia Currently engage in ≥150 minutes of planned moderate physical activity per week for the prior week Are involved in another physical activity intervention

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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-based intervention<br>This arm will receive the active video game-based intervention, which will include attending 12 weekly group sessions at the UTMB Breast Health Clinic, participate in self-paced home session, and monitor daily, weekly, and monthly steps using Wii Fit Meter. All participant will be provided a water bottle and a tote bag as a token of appreciation for participation. | Behavioral: Active video game-based intervention<br>* Attend 12 weekly group session at the UTMB Breast Health Clinic to play the active video games using Wii Fit U or Xbox 360. Participate in self-paced home sessions Monitor daily, weekly, and monthly steps using Wii Fit Meter Feedback on physical activity and physical function<br>|
| Active Comparator: Pedometer<br>This arm will receive the pedometer intervention, which will include attending 3 monthly UTMB Breast Cancer Support Group sessions, and monitor daily, weekly, and monthly steps using a pedometer (Digit-Walker CW-700/701). All participant will be provided a water bottle and a tote bag as a token of appreciation for participation. | Behavioral: Pedometer<br>* Attend 3 monthly UTMB Breast Cancer Support Group Sessions Monitor daily, weekly, and monthly steps using a pedometer (Digi-walker CW-700/701) Feedback on physical activity and physical function<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in physical activity steps per day as measured by an Actigraph monitor | Change in steps per day between 14 weeks and baseline as measured by an Actigraph monitor | Change in steps per day from baseline to 14 weeks | 
| Change in physical activity minutes as measured by an Actigraph monitor | Change in physical activity minutes between 14 weeks and baseline as measured by an Actigraph monitor | Change in physical activity minutes from baseline to 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in physical function as measured by the Short Physical Performance Battery (SPPB) | The SPPB consists of six components: repeated chair sit and stands, balance test, semi-tandem stand, tandem stand, side-by-side stand, and eight feet walk | Change in physical function from baseline and 14 weeks | 
| Change in dietary pattern as measured by the Dietary Screener Questionnaire | Change in dietary pattern from baseline and 14 weeks] [Safety Issue: No] 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, whole grains/fiber, red meat, and processed meat consumption within the past 30 days | Change in dietary pattern from baseline and 14 weeks | 
| Change in quality of life as measured by the Functional Assessment of Cancer Therapy-Breast measure | Changes in physical, social, emotional, functional, and additional well-being between 14 weeks and baseline as measured by FACT-B | Change in quality of life from baseline and 14 weeks | 
| Change in hand grip strength as measured by hand dynamometer | Hand dynamometer estimates the muscle strength generated from flexor muscles of the hand and the forearm | Change in hand grip strength from 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, mHealth, cancer survivor, women's health, breast cancer, physical activity, support group, survivorship