Feasibility and Acceptability of a Telehealth-Based Resistance Training Intervention for Endometrial Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Number of Participants Who Completed 100% of the Prescribed Exercises
研究概览
简要总结
This 2-arm pilot trial will enroll 40 participants to test the feasibility, adherence, and benefits of a home-based strength training intervention for endometrial cancer survivors relative to a wait-listed control group.
详细描述
Endometrial cancer survivors have an extremely high prevalence of inactivity and obesity. Inactivity and obesity are associated with poorer outcomes among survivors. Other interventions have demonstrated that walking and aerobic exercise are safe and feasible in endometrial cancer patients. However few published studies have examined strength training in endometrial cancer survivors, and these have done so only in combination with aerobic intervention (and often also dietary change) in the context of a larger multi-component intervention.
There is a critical need for data about the feasibility and benefits of strength training in this population. The investigators propose a 2-arm pilot trial of a home-based strength training intervention (vs. waitlist control) among 40 endometrial cancer survivors. The intervention will consist of (a) an initial in-person instructional session; (b) instructional materials and resistance training equipment (e.g., resistance bands) and (c) support and feedback provided via video coaching sessions. The purpose of a pilot trial is not to conduct hypothesis testing, but rather to field-test the logistical components of the study to incorporate into a larger, future study design.
The proposed trial will determine the feasibility of an at-home resistance training protocol and measurements of exercise logging, functional fitness testing, DXA, dried blood spots and questionnaire measures. Participants will be assigned either to the resistance training program (i.e., initial in-person instructional session, telephone coaching, and self-monitoring) or to a comparison arm (wait-list control).
- Aim 1: To determine the feasibility of recruiting and retaining endometrial cancer survivors to a home- based resistance training 2 sessions per week of 20-40 minutes of exercise.
- Aim 2: To determine participant satisfaction with each component of the intervention and identify opportunities for refinement of the intervention prior to testing in a larger study.
- Aim 3: To establish that functional and objective assessments are feasible and well-tolerated in enrolled participants, as assessed using the functional fitness test (FFT) battery, dual-energy x-ray absorptiometry (DXA), finger-pricks for dried blood spots and patient-reported outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Willing to provide written informed consent
- •Willing to comply with all study procedures and be available for the duration of the study
- •Fluent in spoken and written English
- •Documented diagnosis of Type I, stage I-IIIc endometrial cancer within the past 5 years
- •Completion of current treatment for endometrial cancer, period of time of ≥10 weeks from treatment completion to study enrollment is required
排除标准
- •Absolute contraindications to exercise (i.e., acute myocardial infarction, severe orthopedic or musculoskeletal limitations
- •Have evidence of recurrent or metastatic disease
- •Are currently performing resistance training ≥2 days per week
- •Report of chest pain, shortness of breath, fainting, or angina pectoris
- •Have physical disability that would limit range of motion through exercises such as sitting, standing and inability to walk one block
- •Plans to move from the area
- •Enrolled in another clinical trial or has used of any investigational drugs, biologics, or devices within 30 days prior to randomization
- •Women who are pregnant or breast-feeding
- •Not suitable for study participation due to other reasons at the discretion of the investigator
结局指标
主要结局
Number of Participants Who Completed 100% of the Prescribed Exercises
时间窗: up to 20 weeks from beginning of intervention
Compliance/adherence will be measured via detailed exercise logs. A participant needs to complete at least 50% of the prescribed exercises in a session to be considered adherent to the session.
Number of Participants With Adverse Events
时间窗: up to 20 weeks
The primary safety endpoint will be total number of adverse events over the duration of the intervention.
Feasibility - Number of Participants Recruited
时间窗: up to 2 years
The feasibility of recruiting endometrial cancer survivors to a home-based resistance training; 2 sessions per week of 20-40 minutes of exercise. This will be measured by the number of participants recruited. The goal is 40 participants.
次要结局
- Change in Fat Mass From Baseline(baseline and 10 weeks)
- Change in Visceral Fat Mass From Baseline(up to 20 weeks)
- Change in Total Percent Body Fat From Baseline(baseline and 10 weeks)
- Change in Number of Arm Curls Performed From Baseline(baseline and 10 weeks)
- Change in Hemoglobin A1c From Baseline(baseline and 10 weeks)
- Change in Handgrip Weight From Baseline(baseline and 10 weeks)
- Change in C-Reactive Protein From Baseline(baseline and 10 weeks)
- Changes in FACT-En From Baseline(baseline and 10 weeks)
- FACT Social Subscale Scores(baseline, 5 weeks, 10 weeks)
- Number of Participants Reporting "Very" or "Extremely" Satisfied With Intervention(At final visit - up to 20 weeks)
- Change in Lean Muscle Mass From Baseline(baseline and 10 weeks)
- Change in Back Scratch Distance From Baseline(baseline and 10 weeks)
- FACT Physical Subscale Scores(baseline, 5 weeks, 10 weeks)
- Self-Efficacy Scores(Baseline, 5 weeks, 10 weeks)
- Change in Number of Sit to Stand Repetitions Performed From Baseline(baseline and 10 weeks)
- Change in 6-minute Walk Distance From Baseline(baseline and 10 weeks)
- FACT-En Scores(baseline, 5 Weeks,10 weeks)
- Change in Steps Per Day From Baseline(baseline and Week 10)
- Change in Sit and Reach Distance From Baseline(baseline and 10 weeks)
- FACT Scores(baseline, 5 weeks, 10 weeks)
- FACT Functional Subscale Scores(baseline, 5 weeks, 10 weeks)
- Changes in Accelerometer-Measured Physical Activity From Baseline(baseline and Week 10)
- Change in 8 Foot Up and Go Time From Baseline(baseline and 10 weeks)
- Changes in FACT From Baseline(baseline and 10 weeks)
- FACT Emotional Subscale Scores(baseline, 5 weeks, 10 weeks)
- Changes in FACT Subscales From Baseline(baseline and 10 weeks)
- Changes in Mental Well-being From Baseline(baseline and Week 10)
- Changes in Self-Efficacy From Baseline(Baseline and 10 weeks)