Breast Cancer Endocrine Therapy FITness (BE-FIT) Trial.
试验速览
- 阶段
- 不适用
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Physical Function
研究概览
简要总结
This project will assess the efficacy of an 8-week virtual exercise program on physical function offered to those with a breast cancer diagnosis currently receiving endocrine therapy. The intervention includes twice-weekly virtual group exercise classes. Participants also complete one to three independent home exercise sessions per week throughout the intervention. Testing will occur virtually at baseline, 8-weeks (at end of program) and follow-up evaluations will be performed at 16-weeks and 12- months after baseline testing. Questionnaires will be administered through REDCap. Exercise sessions and testing will be administered virtually via Zoom.
详细描述
Purpose: The purpose of this study is to test the effect of a virtually delivered supervised exercise program specific to breast cancer survivors on endocrine therapy versus delayed exercise in a partial cross over trial.
Justification: Endocrine therapy is commonly prescribed to breast cancer survivors for 5-10 years and often leads to side effects such as arthralgia, weight gain and bone density loss. Exercise has been shown to be an effective management strategy of these side effects and may improve quality of life and physical functioning. Many barriers exist surrounding the implementation of exercise programs for breast cancer survivors, despite the efficacious outcomes exercise programs have been shown to provide.
Due to COVID-19, virtual delivery options are needed to continue to provide exercise support to cancer patients. In September 2020, members of the investigator team successfully completed a pilot of the virtual intervention (n=30). In British Columbia, the investigators are well positioned to trial the implementation of an exercise program from a virtual setting, with programming specific to women receiving endocrine therapy. The knowledge gained from this study, if shown to be effective, will assist future program delivery and implementation across British Columbia for breast cancer survivors.
Aims and Objectives:
Primary Aim: To evaluate the efficacy of the exercise intervention group versus delayed exercise group to improve physical function, as measured by 30 second sit to stand test, from baseline to end of program (8-weeks).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Stage I - III breast cancer patients who are treated with curative intent
- •Completed primary treatment, including surgery, radiation therapy and/or chemotherapy
- •Currently receiving adjuvant endocrine therapy (Tamoxifen or an Aromatase Inhibitor) for at least 3 months (to allow for acclimatization) and within 3-years of of staring endocrine therapy.
- •Can read and speak English
- •Has access to a tablet, smartphone, laptop or computer with built-in video camera
排除标准
- •Not currently receiving endocrine therapy or scheduled to stop within 6 months
- •Diagnosed with stage IV breast cancer
- •Not willing to attend a twice-weekly exercise program virtually for the duration of the study.
- •Not willing to comply with safety measures of virtual programming (to be seen on camera and monitored via video by the instructor)
结局指标
主要结局
Physical Function
时间窗: Change from baseline to week 8 (end of intervention)
Measured by 30 second sit to stand test
次要结局
- Physical Function(Change from baseline at week 8 (end of intervention), 16 weeks and 12-months)
- Standing balance(Change from baseline at week 8 (end of intervention), 16 weeks and 12-months)
- Medication adherence to endocrine therapy(Change from baseline at week 8 (end of intervention), 16 weeks and 12-months)
- Health-related quality of life(Change from baseline at week 8 (end of intervention), 16 weeks and 12-months)
- Usual physical activity levels(Change from baseline at week 8 (end of intervention), 16 weeks and 12-months)
- Weight in kilograms(Change from baseline at week 8 (end of intervention), 16 weeks and 12-months)
- Height in metres(Change from baseline at week 8 (end of intervention), 16 weeks and 12-months)
- Body mass index(Change from baseline at week 8 (end of intervention), 16 weeks and 12-months)
- Waist circumference(Change from baseline at week 8 (end of intervention), 16 weeks and 12-months)
- Hip circumference(Change from baseline at week 8 (end of intervention), 16 weeks and 12-months)
研究者
Kristin Campbell
Professor
University of British Columbia