Exercise for Advanced Prostate Cancer: a Multicomponent Feasibility Trial in Men With Metastatic Castrate-Resistant Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Feasibility - attrition rates.
研究概览
简要总结
This feasibility study will investigate whether men with metastatic prostate cancer can take part in and progress through a home-based exercise program. This study will evaluate the effects of exercise on a range of disease and treatment-related outcomes.
详细描述
This 12 week multicomponent, tailored, progressive program will consist of both moderate intensity walking and strengthening exercises at home. This single centre, single arm study will incorporate a behavioural change consultation at baseline and weekly behavioural support throughout. This study will follow-up patients at 24 weeks to determine exercise maintenance. Outcome measures will be completed at baseline, 12 and 24 weeks. A qualitative evaluation will be conducted after the 24 week follow-up to determine impact, patient experience and measures that might assist in refining the program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically documented adenocarcinoma of the prostate with progressive systemic metastatic disease despite castrate levels of testosterone (<50ng/dL).
- •At enrolment, patients must have demonstrated progressive disease since the most recent change in therapy.
- •Patients must be on ADT with a GnRH agonist/antagonist or prior bilateral orchiectomy. All patients must be on ADT during the study period.
- •≥ 4 weeks since last surgery and fully recovered.
- •No known contraindications to moderate intensity exercise such as (but not limited to) brain metastases, acute congestive heart failure, unstable angina, serious or non-healing wound, peripheral neuropathy greater than or equal to Grade
- •Recent myocardial infarction.
- •Age ≥ 18 years.
- •ECOG performance status 0-
- •Medical clearance by treating clinician.
排除标准
- •Men currently exceeding ACSM recommended exercise guidelines (150 mins of moderate and/or 60 mins of high intensity exercise per week).
- •Men with brain metastases.
- •Men with a currently active second malignancy other than non-melanoma skin cancer.
- •Congestive heart failure or recent serious cardiovascular event.
- •Chest pain brought on by physical activity.
结局指标
主要结局
Feasibility - attrition rates.
时间窗: Throughout the 24 week study period.
The number of patients that withdraw.
Feasibility - adherence to the exercise intervention.
时间窗: Throughout the 24 week study period.
Determine the percentage of patients adhering to the program and the weekly behavioral consultation sessions.
Feasibility - patient experience.
时间窗: Following the study conclusion at 24 weeks.
Determined by qualitative evaluation, using semi-structured interviews, to assess experiences, accessibility and acceptability of the exercise intervention.
Feasibility - recruitment.
时间窗: At baseline.
The number of participants that agree to participate or are excluded.
Feasibility - safety / adverse events.
时间窗: Monitored throughout the 24 week study period.
Any safety / adverse events, in general or in relation to the exercise program, will be documented by the research team.
次要结局
- Hip and waist circumference analysis.(At baseline, 12 and 24 weeks.)
- Cancer-related fatigue by questionnaire.(At baseline, 12 and 24 weeks.)
- Physical fitness assessment.(At baseline, 12 and 24 weeks.)
- Anthropometric assessment.(At baseline, 12 and 24 weeks.)
- Perceived physical activity levels.(At baseline, 12 and 24 weeks.)
- Quality of life will be measured using questionnaires.(At baseline, 12 and 24 weeks.)
- Pain will be measured through a questionnaire.(At baseline, 12 and 24 weeks.)
- Objectively measure of physical activity levels.(At baseline, 12 and 24 weeks.)
- Quality of life will be measured using a questionnaire.(At baseline, 12 and 24 weeks.)
- Functional ability assessment.(At baseline, 12 and 24 weeks.)
研究者
Gillian Prue
Senior Lecturer
Queen's University, Belfast