A Preference-Based Trial of Two Exercise Delivery Methods in Men With PC on ADT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 5
- 主要终点
- Change in Functional Assessment of Cancer Therapy-Fatigue (FACT-F) scale over time
研究概览
简要总结
Prostate cancer affects 1 in 7 men. Half of these men are treated with androgen deprivation therapy (ADT). ADT slows disease progression and prolongs survival, but it also leads to worse quality of life (QOL), fatigue, loss of strength and fitness, osteoporosis, and diabetes.
The investigators' recent research has shown that individually supervised exercise, supervised group exercise and home-based exercise are equally good at improving these side effects. Now the investigators are doing a larger trial with multiple centres to see whether supervised group or home-based exercise is clinically better and more economical.
A major challenge in such trials is that a significant number of men refuse to be randomized because (a) the participant lives too far from a study centre and cannot come for supervised exercise; or (b) the participant has a strong preference as to which type of exercise program the participant wants to do. Experts have raised concerns that classic randomized trials are too restrictive, selective, and less practical; the study results are less applicable to the real world. Despite its obvious importance, it is not known whether men who refuse to be randomized to an exercise trial but are otherwise willing to participate would benefit similarly to men who are randomized. In this study, we will recruit men who are otherwise eligible for our randomized trial but refuse it for one of the reasons above. We will allow these men to choose either supervised group or home-based exercise, and then compare them to the men who are being randomized to the two treatments in 3 important ways. First, are participants similar in terms of personal characteristics, QOL, and fitness levels? Second, do participants respond similarly to exercise in terms of QOL and physical fitness benefits? Third, do participants actually exercise as much as the randomized men? This work will help the research team understand whether there is a need to change the way exercise trials are done in order to be more relevant and wide-reaching for Canadians with a variety of health conditions.
详细描述
BACKGROUND: The backbone of scientific evidence to address most scientific questions, including behavioural interventions, is randomized controlled trials (RCTs). Prostate cancer is the most common malignancy in men, affecting 1 in 7 men. Almost 50% of these men will receive androgen deprivation therapy (ADT) at some point after diagnosis to reduce disease progression and prolong survival. ADT is associated with multiple adverse effects, including diminished quality of life (QOL), fatigue, reduced muscle mass, and metabolic effects. Numerous RCTs in the setting of men on ADT have demonstrated that exercise programs, particularly supervised 1:1 in-centre programs, are clinically effective. However, they are resource-intensive and have low scalability. Alternative delivery models such as group-based supervised exercise or home-based exercise are promising alternatives but require rigorous efficacy data. While conducting a two-centre exercise trial comparing different exercise delivery models, fewer than 40% of eligible men agreed to participate. Two common reasons why men declined participation were distance to exercise centres and unwillingness to be randomized. Novel clinical trial designs, such as preference-based trials, may help answer effectiveness questions and enhance generalizability by recruiting a more representative pool of men. Increased efficiencies in recruitment, however, may come at a cost of bias with non-randomized designs as well as differential effects of exercise and varying adherence. In parallel with a multi-centre phase III RCT funded by CIHR, we propose to conduct a pilot preference-based trial, examining 3 key issues. First, can we successfully enroll men who are unwilling to be randomized due either to distance from centre or a strong preference for one exercise delivery model? Second, are these men different from men who are randomized in terms of baseline characteristics, study retention, and adherence to the intervention? Third, are the benefits of an exercise program similar to men who are randomized to the same arm?
OBJECTIVES:
To determine, in men with PC on ADT who are otherwise eligible to participate in a RCT of different exercise delivery models but decline to be randomized due to distance from the study centre or strong preference for one exercise delivery model:
- What proportion of these men is willing to be enrolled in a preference-based trial.
- How comparable are baseline characteristics of men who agree to participate in the intervention arm of their choice and all those in the randomized study?
- How comparable are study retention and adherence to the intervention for men in the corresponding arms of the preference based trial and randomized trial?
- How comparable are the benefits in terms of quality of life (QOL) and physical fitness outcomes in those with a preference for a particular exercise and those without a preference?
HYPOTHESES
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •fluent in English,
- •able to provide consent.
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
Change in Functional Assessment of Cancer Therapy-Fatigue (FACT-F) scale over time
时间窗: Baseline, 3, 6, 12 months
The FACT-F is a questionnaire that includes 13 items measuring cancer-related fatigue. Total Score Range = 0-52 (higher score = lower fatigue)
Change in 6 minute walk test (6MWT) scores over time
时间窗: Baseline, 3, 6, 12 months
The 6MWT is a commonly used, validated measure that assesses functional endurance.
次要结局
- Change in Functional Assessment of Cancer Therapy-General (FACT-G) scale over time(Baseline, 3, 6, 12 months)
- Change in Functional Assessment of Cancer Therapy-Prostate (FACT-P) scale over time(Baseline, 3, 6, 12 months)
- Change in 5 Timed Chair Stand Test over time(Baseline, 3, 6, 12 months)
- Change in grip strength using a Jamar dynamometer over time(Baseline, 3, 6, 12 months)
- Change in body composition (fat mass, fat free mass, and body fat percentage) measured via body impedance analysis (BIA) over time(Baseline, 6, 12 months)
- Change in fasting lipids over time(Baseline, 6, 12 months)
- Change in blood glucose over time(Baseline, 6, 12 months)
- Change in glycated hemoglobin over time(Baseline, 6, 12 months)
- Change in hemoglobin over time(Baseline, 6, 12 months)
- Change in prostate specific antigen (PSA) over time(Baseline, 6, 12 months)
- Change in weekly minutes of moderate-vigorous physical activity (MVPA) over time(Baseline, 3, 6, 12 months)
- Change in Health Care Climate Questionnaire (HCCQ) over time(Baseline only)
- Change in Behavioral Regulations in Exercise Questionnaire-2 (BREQ-2) over time(Baseline, 6, 12 months)
- Change in Psychological Need Support and Frustration Scale - Relatedness Items (PNSF - Relatedness Items) over time(Baseline, 6, 12 months)
- Change in Planning, Attitudes, & Barriers scale over time(Baseline, 6, 12 months)