RISE: Remote Intervention for Strength Training in Endometrial Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Satisfaction with program - self-reported
研究概览
简要总结
This clinical trial studies how well a remotely delivered home-based exercise program for strength training works to positively impact endometrial cancer (EC) survivorship for patients with decreased cancer survivorship access. Cancer survivors in rural areas face barriers to supportive care, including geographic and environmental barriers to exercise and technology. Rural areas in the Midwest are underserved in terms of cancer care thus, it is essential to develop and test interventions that are scalable and can reach many individuals including those living in rural areas. Remotely-delivered exercise intervention approach allows for cancer survivors who may live far away from their primary treatment center to engage in supportive therapy via exercise interventions delivered in a sustainable context. In addition, historically black, hispanic and native endometrial cancer survivors have shorter survival and less access to survivorship care, so alternative models for healthcare delivery are needed in this underserved group. Information gained from this research may help determine whether utilizing a remotely delivered exercise program can positively impact EC survivorship for patients with decreased cancer survivorship access.
详细描述
PRIMARY OBJECTIVES:
I. To develop and tailor a fully remote home-based exercise intervention for EC patients.
II. To test the recruitment and retention and acceptability of a fully remote home-based telehealth exercise intervention in older adult patients that live in rural America and are survivors of early stage, low risk endometrial cancer.
III. To measure the effectiveness of exercise intervention on quality of life in endometrial cancer patients, specifically in the realm of physical functioning.
OUTLINE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Stage IA-IB endometrial cancer
- •Grade 1-2 disease
- •No recurrence documented
- •Internet access
- •Access to a remote device with a camera such as a computer, smartphone or tablet
- •> 1 year but less than 5 years from surgery
- •Primary residence in rural-urban commuting area (RUCA) (rural-urban commuting area) codes 4.0 through 10.0 or of American Indian, Alaskan Native, Black or Hispanic background
排除标准
- •Paraplegia/hemiplegia
- •No English speaking
研究组 & 干预措施
Supportive Care (home-based exercise program)
Participants participate in a home-based exercise program with an exercise prescription that will include resistance band and body weight exercises targeting the 5 major large muscle groups along with 3 booklets about exercise and exercise training and attend weekly exercise coaching sessions to report on exercise adherence and to progress exercise over 10 weeks on study.
干预措施: Telemedicine (Other)
Supportive Care (home-based exercise program)
Participants participate in a home-based exercise program with an exercise prescription that will include resistance band and body weight exercises targeting the 5 major large muscle groups along with 3 booklets about exercise and exercise training and attend weekly exercise coaching sessions to report on exercise adherence and to progress exercise over 10 weeks on study.
干预措施: Exercise Counseling (Other)
Supportive Care (home-based exercise program)
Participants participate in a home-based exercise program with an exercise prescription that will include resistance band and body weight exercises targeting the 5 major large muscle groups along with 3 booklets about exercise and exercise training and attend weekly exercise coaching sessions to report on exercise adherence and to progress exercise over 10 weeks on study.
干预措施: Exercise Intervention (Other)
Supportive Care (home-based exercise program)
Participants participate in a home-based exercise program with an exercise prescription that will include resistance band and body weight exercises targeting the 5 major large muscle groups along with 3 booklets about exercise and exercise training and attend weekly exercise coaching sessions to report on exercise adherence and to progress exercise over 10 weeks on study.
干预措施: Health Promotion and Education (Other)
Supportive Care (home-based exercise program)
Participants participate in a home-based exercise program with an exercise prescription that will include resistance band and body weight exercises targeting the 5 major large muscle groups along with 3 booklets about exercise and exercise training and attend weekly exercise coaching sessions to report on exercise adherence and to progress exercise over 10 weeks on study.
干预措施: Interview (Other)
Supportive Care (home-based exercise program)
Participants participate in a home-based exercise program with an exercise prescription that will include resistance band and body weight exercises targeting the 5 major large muscle groups along with 3 booklets about exercise and exercise training and attend weekly exercise coaching sessions to report on exercise adherence and to progress exercise over 10 weeks on study.
干预措施: Physical Performance Testing (Other)
Supportive Care (home-based exercise program)
Participants participate in a home-based exercise program with an exercise prescription that will include resistance band and body weight exercises targeting the 5 major large muscle groups along with 3 booklets about exercise and exercise training and attend weekly exercise coaching sessions to report on exercise adherence and to progress exercise over 10 weeks on study.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Satisfaction with program - self-reported
时间窗: 10 weeks
Assessed by a simple participant satisfaction survey after completion of the 10-week exercise intervention. Qualitative interviews will be performed at the completion of the program regardless of level of participation to assess facilitators, barriers, and motivators to participation.
Retention of participants
时间窗: Up to 6 months
Assessed by the number of patients who complete 75% or more of the twice weekly exercise program.
Satisfaction with program - self-reported
时间窗: 10 weeks
Assessed by a simple participant satisfaction survey after completion of the 10-week exercise intervention. Qualitative interviews will be performed at the completion of the program regardless of level of participation to assess facilitators, barriers, and motivators to participation.
Feasibility of intervention
时间窗: Up to 6 months
Technological questions and problems that arise during the exercise intervention will be recorded to assess the ability to fully perform telehealth exercise interventions in a rural cancer population
次要结局
- Change in physical function(Baseline; 10 weeks (end of exercise intervention); 6 months)