An Individualised 8-week Remote Exercise Intervention to Improve QoL, Cardiometabolic Risk and Physical Activity Level in Men With Prostate Cancer Undergoing ADT Treatment.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Functional Assessment of Cancer Therapy-Prostate
研究概览
简要总结
Currently, there are few opportunities for patients with cancer to have individual exercise guidance, and this has further been impacted by the Covid-19 pandemic. However, during the pandemic the use of virtual/remote platforms has been crucial in delivering care to cancer patients. The investigators think that remote exercise training may also offer a solution to support positive change in prostate cancer patients. As a result, the investigators have developed a remote/online exercise programme to explore this further.
This study will explore the effectiveness of an 8-week remote exercise and behavioural support intervention, and whether prostate cancer patients feel they benefit from this. The study also aims to see if this sort of exercise programme can be delivered to more prostate cancer patients in the future. This project is open to men with prostate cancer on long term hormone therapy. The intervention will be comprised of one remote supervised session per week, completed 1-1 using an online platform and up to two additional sessions, depending on its suitability for the patient, will be prescribed as unsupervised home-based exercise.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Have had an orchiectomy OR;
- •Are receiving a GnRH agonist/antagonist OR;
- •Are currently receiving Abiraterone, Enzalutamide, Apalutamide or Darolutamide
- •Long-term retention is planned (intending to remain on the above stated treatments for at least the next 6 months).
排除标准
- •Patients who are currently classed as in active treatment i.e. are currently receiving chemotherapy/radiation therapy (Note: Patients that are included in the study but after inclusion are moved onto chemo/radiation therapy, will still be able to participate in the project).
- •Patients who are stratified as high risk for having a cardiovascular event.
- •Acute illness; or any musculoskeletal, cardiovascular or neurological disorder that could inhibit or put them at risk from exercising, as determined by screening and their clinician.
- •Men with painful or unstable bony metastases.
结局指标
主要结局
Functional Assessment of Cancer Therapy-Prostate
时间窗: t= 0, 4, 8, 16 & 30 weeks
Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire. Twenty-seven questions about physical, social/family, emotional and functional well-being are graded from 0-4 (0 = not at all; 4 = very much), yielding a total between 0 and 108.
Functional Assessment of Cancer Therapy
时间窗: t= 0, 4, 8, 16 & 30 weeks
Functional Assessment of Cancer Therapy fatigue (FACIT-f) questionnaire. The FACIT-Fatigue is a validated questionnaire that was originally developed for the precise evaluation of fatigue levels in cancer patients with anemia. It consists of 13 questions using a 5 point scale (0=not at all; 1 = a little bit, 2 = somewhat, 3 = quite a bit and 4 = very much). It has been used frequently in the clinical trial setting (please see appendix 1). Responses to each question are added with equal weight to obtain a total score. The range of possible scores is 0-52, with 0 corresponding to the highest level of fatigue and 52 corresponding to the lowest level of fatigue.
次要结局
- Leisure time physical activity(t= 0, 4, 8, 16 & 30 weeks)
- Physical activity(t= 0, 4, 8, 16 & 30 weeks)
- Cardiovascular risk(t= 0, 4, 8 weeks)
- Exercise adherence(weekly for 8 weeks)
- Health status(t= 0, 4, 8, 16 & 30 weeks)