Pink Warrior-Support Group Toolkit for Breast Cancer Survivors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2019-01-31

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.

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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.

Conditions

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Breast Cancer Physical Activity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Active video game-based intervention

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.

Group Type EXPERIMENTAL

Active video game-based intervention

Intervention Type BEHAVIORAL

* 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

Pedometer

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.

Group Type ACTIVE_COMPARATOR

Pedometer

Intervention Type BEHAVIORAL

* 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

Interventions

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Active video game-based intervention

* 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

Intervention Type BEHAVIORAL

Pedometer

* 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Provide informed consent
2. Diagnosed with primary female breast cancer within 0 to 6 months period of time
3. English-speaking between the ages of 18 and 70
4. Able to read and write in English
5. Obtained approval from oncologists for the participant to be involved in the physical activity based support group
6. Able to travel to the UTMB Breast Health Center
7. Able to move arms and legs as well as ambulate
8. Able to see TV screen from a distance of 2 to 4 feet

Exclusion Criteria

1. Being pregnant
2. Dementia
3. Currently engage in ≥150 minutes of planned moderate physical activity per week for the prior week
4. Are involved in another physical activity intervention

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No