Implementing Physical Activity for Individuals With Cancer During Treatment: The IMPACT Implementation-Effectiveness Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 129
- 试验地点
- 6
- 主要终点
- Physical activity level
研究概览
简要总结
More Canadians are surviving cancer, however, individuals with cancer live with side effects for years after treatments have ended. The physical and psychosocial benefits of regular physical activity (PA) during and after cancer treatment are well established. However, less than 30% of individuals with cancer meet current PA recommendations and PA levels decline significantly during treatment. PA services within the cancer institution to support well-being during treatment are not available for survivors across Ontario. Strategies are needed within cancer centres to close the gap between the evidence and clinical practice.
What is the purpose? To evaluate the effectiveness of a novel exercise and education strategy for individuals with cancer during treatment.
What are we proposing to do? This project includes two parts. In Part 1 participants will be put into one of three groups. Group 1 (Exercise & self-management) will include eight sessions of supervised, institution-based exercise and self-management education. Group 2 (self-management only) will include eight virtual self-management education sessions with an exercise professional. Group 3 will receive usual care (i.e., no intervention).
In Part 2 participants who attended less than 75% of their sessions will be asked to complete an interview on the barriers to continuing with the study during cancer treatment.
Why is this work important? Findings from this trial will inform the way PA services are provided within cancer institutions across Ontario. This novel strategy incorporates both institution-based and home-based exercise strategies during treatment and highlights the importance of individuals with cancer taking an active role in managing their condition during treatment. This can prevent future complications and decrease burden on the individual and the healthcare system. Results will inform future decisions on PA implementation strategies for cancer survivors with diverse needs across Ontario.
详细描述
Rationale:
The burden of cancer in Canada is growing. More individuals are surviving cancer, however, individuals with cancer live with side effects for years after treatments have ended. The physical and psychosocial benefits of regular physical activity (PA) during and after cancer treatment are well established. However, less than 30% of individuals with cancer meet current PA recommendations and PA levels decline significantly during active treatment. Institution-based PA services to support wellbeing and minimize burden during treatment are not available across Ontario. Novel implementation strategies are needed within the institution to close the gap between the evidence and clinical practice. Implementation research allows us to understand how to deliver interventions effectively in diverse settings.
Aim & Objectives:
The overall aim of this project is to conduct a fully powered, multi-centred randomized controlled trial (RCT) to evaluate the effectiveness of a novel implementation strategy including exercise and SM versus usual care for individuals with cancer during treatment. To do this, there are two main objectives: 1) Determine the feasibility and effectiveness of a novel implementation strategy using exercise and SM during treatment
Methods:
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
- Double (Investigator, Outcomes Assessor)
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
- •adults with a cancer diagnosis (any type or stage)
- •individuals are currently receiving treatment for cancer
- •individuals have been cleared for exercise by their oncology care team
排除标准
- •Self-report any chronic condition, cognitive impairment, or injury that would prevent them from participating in moderate intensity exercise
研究组 & 干预措施
Self-Management Only
干预措施: Self-management e-module (Behavioral)
Usual Care
Exercise & Self-Management
干预措施: Exercise (Behavioral)
Exercise & Self-Management
干预措施: Self-management e-module (Behavioral)
结局指标
主要结局
Physical activity level
时间窗: 6-months
Godin Leisure Time Exercise Questionnaire
次要结局
- Quality of life(12-months)
- Level of exercise knowledge(12-months)
- Health status(12-months)
- Aerobic capacity(12-months)
- Cardiovascular outcomes - Blood pressure(12-months)
- Cardiovascular outcomes - Heart rate(12-months)