A Randomized Control Trial (RCT) and Economic Analysis of Two Exercise Delivery Methods in Men With Prostate Cancer on ADT
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 7
- 主要终点
- Functional Assessment of Cancer Therapy-Fatigue (FACT-F)
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 and (b) home-based supported 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.
Participants (men with PC on ADT) will be recruited from one of the following cancer centres: Princess Margaret Cancer Centre in Toronto, the Tom Baker Cancer Centre in Calgary, the Southlake Regional Health Centre in Newmarket, and Scarborough and Rouge Hospital - Centenary Site in Scarborough. When a patient agrees to participate, patient will be randomly placed in 1 of 2 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
- •men with histologically confirmed PC who are starting or continuing on ADT for at least 6 months or who are in an androgen-deprived (or castrate) state for the duration of the intervention
- •fluent in English
- •able to provide consent
- •close to a study centre
排除标准
- •already meeting guidelines for moderate to vigorous physical activity (MVPA) - conditions that would interfere with ability to participate
结局指标
主要结局
Functional Assessment of Cancer Therapy-Fatigue (FACT-F)
时间窗: Every 3 Months for 12 Months
The FACT-F is a questionnaire that includes 13 items measuring cancer-related fatigue.
6 Minute Walk Test (6MWT)
时间窗: Every 3 Months for 12 Months
The 6MWT is a commonly used, validated measure that assesses functional endurance.
次要结局
- Functional Assessment of Cancer Therapy-Prostate (FACT-P)(Every 3 Months for 12 Months)
- 5 Times Sit to Stand Test(Every 3 Months for 12 Months)
- Grip Strength(Every 3 Months for 12 Months)
- Bioelectrical Impedance Analysis(Every 6 Months for 12 Months)
- Waist Circumference and Hip Ratio(Every 6 Months for 12 Months)
- Body Mass Index(Every 6 Months for 12 Months)
- Bone Mineral Density (BMD)(Every 6 Months for 12 Months)
- Biological Outcomes (blood work)(Every 6 Months for 12 Months)
- Sedentary Behaviour(Every 6 Months for 12 Months (unless otherwise specified))
- Planning, Attitudes, & Barriers scale(Every 6 Months for 12 Months (unless otherwise specified))
- Functional Assessment of Cancer Therapy-General (FACT-G)(Every 3 Months for 12 Months)
- Behavioral Regulations in Exercise Questionnaire-2 (BREQ-2)(Every 6 Months for 12 Months (unless otherwise specified))
- Psychological Need Support and Frustration Scale - Relatedness Items(Every 6 Months for 12 Months (unless otherwise specified))
- Health Care Climate Questionnaire (HCCQ)(Baseline only)
- Walkability(Baseline only)
- Disease-related Costs(Every 3 Months for 12 Months)
- Exercise Adherence(Every 3 Months for 12 Months)