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临床试验/NCT04259905
NCT04259905已完成不适用

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

The University of Texas Medical Branch, Galveston4 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年5月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
4
主要终点
Walking Physical Activity as Measured by Change in Daily Steps From Baseline to 14 Weeks

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.

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.

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
55 Years 至 79 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • Diagnosed dementia
  • Currently engage in 150 minutes or more of planned moderate intensity physical activity
  • Currently involved in another physical activity intervention

结局指标

主要结局

Walking Physical Activity as Measured by Change in Daily Steps From Baseline to 14 Weeks

时间窗: 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

次要结局

  • Physical Performance as Measured by the Change in Short Physical Performance Battery Scores From Baseline to 14 Weeks(Baseline to 14 weeks)
  • Quality of Life as Measured by the Change in FACT-B Scores From Baseline to 14 Weeks(Baseline to 14 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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