Home Based Exercise for Patients With Breast or Prostate Cancer During Treatment: a Feasibility Trial (The BENEFIT-CA Study)
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Trial adherence
研究概览
简要总结
The purpose of this trial is to evaluate the feasibility of a home based exercise program for individuals with breast or prostate cancer patients undergoing active treatment.
详细描述
This feasibility trial aims to assess a home-based exercise program, including a 3-month intervention of structured physical activity and health education for individuals with breast or prostate cancer. The main objective of this trial is to assess the adherence of cancer patients to a program of structured exercise, mixed with a health education approach, implemented and accompanied in a remote approach.
The data collection will include variables related to: (a) recruitment and retentions rates; (b) attendance to exercise sessions; (c) fatigue and quality of life levels; (d) functional capacity levels; (e) adverse events related or not to the study; (f) patient selected outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •eighteen years old minimum;
- •be living in Porto Alegre or metropolitan region;
- •breast cancer stage 0 - III OR
- •localized prostate cancer;
- •undergoing hormonal treatment / manipulation in isolation or combined with other therapies three months prior to the entrance in the study;
- •hormonal therapy / manipulation planned to be active throughout the study duration;
- •not engaged in any exercise training for more than once a week for the past 6 months;
- •in case of previous surgical procedure, the patient must have medical clearance at the moment of the contact to begin the study or be cleared to do so in the near future (up to two weeks).
排除标准
- •metastatic phase / progression of the disease or active regional location prior to beginning of the study;
- •inability to understand the terms and conditions of study due to language, hearing, cognitive or severe psychiatric issues;
- •another family member, who lives at the same residence, participating in the study;
- •planning to move or major absence (more than two weeks) during the study;
- •history of cardiovascular disease (except controlled hypertension) or severe cardiopulmonary disease, as well as history of heart attack, revascularization procedures, profound venous thrombosis, encephalic vascular accident (brain stroke) or pulmonary embolism in the past twelve months;
- •chronic pulmonary disease that requires oxygen or corticosteroid therapy;
- •kidney disease with or that is going to begin the use of dialysis or waiting for a kidney transplant;
- •severe nausea, anorexia or any other condition which does not allow to perform physical exercise;
- •medical contraindication to exercise training.
结局指标
主要结局
Trial adherence
时间窗: Up to12 weeks.
Proportion of self-reported exercise episodes (out of 36 episodes, total) during the study.
次要结局
- Recruitment yields(Up to 8 weeks before allocation to the study intervention.)
- Adverse events throughout the study(Up to 12 weeks.)