Pink Warrior-Support Group Toolkit for Breast Cancer Survivors
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.
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Texas
-
Galveston、Texas、美国、77550
- The University of Texas Medical Branch
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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.
|
|
|
有源比较器：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.
|
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in physical activity steps per day as measured by an Actigraph monitor
大体时间：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 steps per day from baseline to 14 weeks
|
|
Change in physical activity minutes as measured by an Actigraph monitor
大体时间：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
|
Change in physical activity minutes from baseline to 14 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in physical function as measured by the Short Physical Performance Battery (SPPB)
大体时间：Change in physical function from baseline and 14 weeks
|
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
大体时间：Change in dietary pattern from baseline and 14 weeks
|
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
大体时间：Change in quality of life from baseline and 14 weeks
|
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
大体时间：Change in hand grip strength from baseline to 14 weeks
|
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
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in weight
大体时间：Change in weight from baseline to 14 weeks
|
Change in body weight between 14 weeks and baseline as measured by a weight scale in the clinic
|
Change in weight from baseline to 14 weeks
|
|
Change in waist circumference
大体时间：Change in waist circumference from baseline to 14 weeks
|
Change in waist circumference between 14 weeks and baseline as measured by Seca-203
|
Change in waist circumference from baseline to 14 weeks
|
|
Change in physical activity minutes, measured by the Community Healthy Activities Model Program for Seniors
大体时间：Change in physical activity minutes from baseline to 14 weeks
|
Self-reported physical activity questionnaire
|
Change in physical activity minutes from baseline to 14 weeks
|
|
Change in physical function, measured by PROMIS measure specific to cancer survivors
大体时间：Change in physical function from baseline to 14 weeks
|
Changes in overall self-reported physical functions between 14 weeks and baseline as measured by PROMIS-Ca Bank v1.1-Physical
Function
|
Change in physical function from baseline to 14 weeks
|
|
Change in fatigue, measured by PROMIS measure specific to cancer survivors
大体时间：Change in fatigue from baseline to 14 weeks
|
Changes in overall self-reported fatigue level between 14 weeks and baseline as measured by PROMIS-Ca Bank v1.1-Fatigue
|
Change in fatigue from baseline to 14 weeks
|
|
Change in exercise motivation, measured by autonomous motivation specific to physical activity
大体时间：Change in motivation from baseline to 14 weeks
|
Behavioral regulation in Exercise Questionnaire-2 will be used
|
Change in motivation from baseline to 14 weeks
|
|
Change in psychological feelings, measured by Psychological Need Satisfaction in Exercise Scale
大体时间：Change in psychological feelings from baseline to 14 weeks
|
Sub-scales included perceived competence, perceived autonomy, and perceived relatedness
|
Change in psychological feelings from baseline to 14 weeks
|
|
Change in self-regulation, measured by Rovinak et al. scale
大体时间：Change in self-regulation from baseline to 14 weeks
|
Sub-scales include exercise goals and exercise plans
|
Change in self-regulation from baseline to 14 weeks
|
|
Feasibility-Adherence
大体时间：14 weeks
|
Adherence will be measured by number of participants who completed at least 80% of the program activities.
|
14 weeks
|
|
Feasibility-Attrition
大体时间：14 weeks
|
Attrition will be measured by percentage of people who dropped out of the intervention program.
|
14 weeks
|
|
Feasibility-Technological Issues
大体时间：14 weeks
|
Technological issues will be measured by counting number of occurrence
|
14 weeks
|
|
Feasibility-Adverse Events
大体时间：14 weeks
|
Adverse events will be measured by counting number of occurrence
|
14 weeks
|
|
Acceptability
大体时间：14 weeks
|
Participant acceptability and satisfaction will be assessed by a questionnaire with 5-point scale responses
|
14 weeks
|
合作者和调查者
调查人员
- 首席研究员：Maria Swartz, PhD, MPH、The University of Texas Medical Branch
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.