Prehabilitation to Patients With Prostate Cancer, Who Are About to Receive Androgen Deprivation Therapy and Radiation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- Change from baseline to follow-up in quality of life measured by EORTC-QLQ-C30
研究概览
简要总结
The goal of this feasibility study is to test a newly developed, multicomponent prehabilitation intervention to patients with prostate cancer, to improve their resilience to treatment side-effects. The main questions it aims to answer are:
- Are patients and their close relatives willing to take part in prehabilitation?
- What is the acceptability and feasibility of the prehabilitation intervention, seen from the perspectives of patients, their close relatives, and healthcare professionals?
- Are the planned data collection methods feasible, and are there indications of a clinical effect?
Participants will:
- Take part in 12 weeks of physical exercise training
- Attend a 4-day residential prehabilitation intervention, where they receive education and do exercises. After 12 weeks, it is possible to take part in a voluntary follow-up session.
- Patients will respond to questionnaires about their health, symptoms, and quality of life. Patients and their close relatives will attend a group interview. Patients will also complete an exercise diary and brief physical tests
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with prostate cancer
- •min 18 years old
- •Treatment: Androgen deprivation therapy and raditation therapy
- •Resident in Vejle Municipality or Esbjerg Municipality
- •Can take part in residential prehabiliation in week 43 or 50, 2025, as well as physical exsercise training in the municipality
- •Willing to take part in a research study
- •Suited to take part in group sessions
- •Be able to read and be understood in Danish
- •Be responsible for own personal hygiene and medications at the 4-day residential stay
排除标准
- •Persons who do not fulfil the inclusion criteria will be excluded
研究组 & 干预措施
Patients receiving prehabilitation
The prehabilitation intervention includes: - Education about the disease and treatment - Physical exsercise training - Values in life - Energy preservation - Nutrition with a focus on hormone therapy - Identiy and role changes - Intimacy and sexuality - Sleep - Pelvic floor training - An individual session with a healthcare professional incl. goal setting
干预措施: Prehabilitation (Behavioral)
结局指标
主要结局
Change from baseline to follow-up in quality of life measured by EORTC-QLQ-C30
时间窗: From baseline (shortly after enrollment) to 24 and 48 weeks later.
This is a pilot study with one arm only, thus the aim is mainly to test the feasibility of the chosen primary outcome measure, including whether there are tendencies in data that support the aim of participants maintaining stable quality of life. Hence, measured by the European Organization for the Research and Treatment of Cancer Qality of life Questionnaire (EORTC QLQ-C30), the target is unchanged (stable) quality of life measured from baseline to follow-up at 24 and 48 weeks.
次要结局
- Change in prostate-cancer related symptoms and problems from baseline to follow-up measured by the EPIC-26(Measured at baseline (shortly after recruitment) and at 24 and 48 weeks.)
- Change in anxiety from baseline to follow up measured by the GAD-7(At baseline (shortly after inclusion) and at 24 and 48 weeks.)
- Change in depression from baseline to follow-up measured by the PHQ-9(Measured at baseline (shortly after inclusion) and at 24 and 48 weeks)
- Change in muscle strength from baseline to follow-up measured by 30 sec sit-to-stand test(Baseline and after finished exercise training at 12 weeks)
- Change in fatigue from baseline to follow-up using the BFI(Measured at baseline (shortly after inclusion) and at 24 and 48 weeks.)
- Change in BMI from baseline to follow-up calculated from self-reported height and weight(Baseline and at 24 and 48 weeks.)
- Change in function from baseline to follow-up measured by the 6MWT(Baseline and after finished exercise training at 12 weeks)