A Pilot RCT and Economic Analysis of Three Exercise Delivery Methods in Men With Prostate Cancer on ADT
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 4
- 主要终点
- Change from baseline in health-related quality of life (QOL) at 3, 6, 9, and 12 months
研究概览
简要总结
Prostate Cancer (PC) affects 1 in 7 men. Nearly half of those diagnosed with PC will receive androgen deprivation therapy (ADT) as part of their treatment. ADT is good at managing PC but has many side effects. Researchers have shown that exercise, specifically one-on-one supervised exercise improves many of the side effects of ADT. However, exercise programs for men on ADT are not widely available. More questions need to be answered in order for exercise programs to become part of PC treatment. First, can programs that require fewer resources, such as group-exercise or home-based exercise, also improve ADT side-effects? Second, do exercise-related benefits continue beyond the structured exercise program? And what makes people continue exercising? Third, which exercise program is most cost-effective?
In this study, the investigators will compare: (a) group supervised in-centre; (b) home-based supported; and (c) 1:1 supervised in-centre exercise programs to see which program is most effective for men with PC on ADT. The investigators will also look at what motivates people to continue to exercise both during a structured program and after the program is complete and will examine which exercise program is most cost-effective.
The investigators will ask men with PC on ADT that are being treated at either Princess Margaret Cancer Centre in Toronto or the Tom Baker Cancer Centre in Calgary to participate in the study. When a patient agrees to participate, he will be randomly placed in 1 of the 3 exercise programs. All programs will include the same type of exercises (aerobic, resistance and flexibility) and all participants will exercise 4-5 days per week for 30 minutes per day (as tolerated) for the length of the program (6 months). The investigators will look at how men with PC on ADT respond to the exercise program by measuring quality of life (QOL), fatigue and different physical measures before, during, and after the exercise program.
Although the investigators know that supervised one-on-one exercise is most effective at improving ADT side-effects, it is unknown if other forms of exercise are just as beneficial and more financially responsible. This study will allow the investigators to begin to answer these questions so that structured exercise programs become a regular part of PC treatment.
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
- Single (Outcomes Assessor)
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •confirmed prostate cancer
- •starting or continuing on ADT for at least 6 months
- •fluent in English
- •able to provide consent
- •live close to a study centre
- •screened with the Physical Activity Readiness Questionnaire (PAR-Q+ or PARmed-X) to ensure safe exercise participation OR receive medical clearance by attending physician
排除标准
- •already meeting guidelines for moderate to vigorous physical activity (MVPA) as defined by the Canadian Physical Activity Guidelines (greater than or equal to 150 minutes of MVPA per week)
- •conditions that would interfere with ability to participate
结局指标
主要结局
Change from baseline in health-related quality of life (QOL) at 3, 6, 9, and 12 months
时间窗: Every 3 months for 1 year
Measured by the Functional Assessment of Cancer Therapy-General (FACT-G), health-related QOL refers to those aspects of QOL that relate a person's health to their physical, functional, psychological, and social well-being. The FACT-G is a well-validated and widely used QOL measure. It can be completed in 8-10 minutes and has published normative data.
次要结局
- Change from baseline in fatigue at 3, 6, 9, and 12 months(Every 3 months for 1 year)
- Change from baseline in aerobic fitness (VO2peak) at 3, 6, 9, and 12 months(Every 3 months for 1 year)
- Change from baseline in quality of life (QOL) at 3, 6, 9, and 12 months(Every 3 months for 1 year)
- Change from baseline in musculoskeletal fitness at 3, 6, 9, and 12 months(Every 3 months for 1 year)
- Change from baseline in grip strength at 3, 6, 9, and 12 months(Every 3 months for 1 year)
- Change from baseline in bone mineral density at 12 months(Baseline and 1 year.)
- Change from baseline in adherence predictors at 3, 6, 9, and 12 months(Every 3 months for 1 year)
- Change from baseline in biological outcomes at 6 and 12 months(Every 6 months for 1 year)
- Change from baseline in body composition at 6 and 12 months(Every 6 months for 1 year)
- Change from baseline in cost-effectiveness at 3, 6, 9, and 12 months(Every 3 months for 1 year)