Pink Warrior-Support Group Toolkit for Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in physical activity steps per day as measured by an Actigraph monitor
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Being pregnant
- •Currently engage in ≥150 minutes of planned moderate physical activity per week for the prior week
- •Are involved in another physical activity intervention
结局指标
主要结局
Change in physical activity steps per day as measured by an Actigraph monitor
时间窗: Change in steps per day from baseline to 14 weeks
Change in steps per day between 14 weeks and baseline as measured by an Actigraph monitor
Change in physical activity minutes as measured by an Actigraph monitor
时间窗: Change in physical activity minutes from baseline to 14 weeks
Change in physical activity minutes between 14 weeks and baseline as measured by an Actigraph monitor
次要结局
- Change in dietary pattern as measured by the Dietary Screener Questionnaire(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(Change in quality of life from baseline and 14 weeks)
- Change in physical function as measured by the Short Physical Performance Battery (SPPB)(Change in physical function from baseline and 14 weeks)
- Change in hand grip strength as measured by hand dynamometer(Change in hand grip strength from baseline to 14 weeks)