A Digitally Distributed Yoga Intervention in Prostate Cancer Rehabilitation (DigiYoga-P): Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Does internet-based yoga have any effect on stress compared to standard care?
研究概览
简要总结
Prostate cancer and its treatment can affect psychological, physical, and social quality of life. The most common side effects of the disease and treatment are bowel and urinary problems, sexual issues, and reduced quality of life. These issues can be alleviated with proper treatment and rehabilitation. Stress has been shown to be a significant factor in reduced quality of life.
The overall aim of the research project is to evaluate and compare the effect of an internet-based yoga intervention for individuals diagnosed with prostate cancer with a control group receiving standard care regarding stress, urinary incontinence, blood pressure, and quality of life. Additional objectives include describing cost-effectiveness and the experience of participating in an internet-based yoga intervention at home.
Scientific Questions Does internet-based yoga have any effect on stress, urinary incontinence, blood pressure, and quality of life compared to standard care? Is internet-based yoga a cost-effective intervention from the perspective of healthcare and society compared to standard care? How feasible is internet-based yoga, and how do participants perceive it? Does blood pressure change due to digital yoga, and does the effect persist after one year? Do participants in the intervention group continue practicing yoga after the intervention ends?
详细描述
There are no studies evaluating the effect of digital yoga in individuals diagnosed with prostate cancer.
The study is a randomized controlled multicenter study, where participants are randomized to an internet-based yoga intervention or a control group.
Study Participants Inclusion criteria are men diagnosed with prostate cancer without signs of metastatic disease, treated with curative intent.
Recruitment Participants are recruited through urology clinics and patient associations nationwide, as well as through social media such as Facebook and Instagram, and physical platforms such as bulletin boards and conferences. . receives standard care: standardized information about the importance of physical activity is included in the patients' care plan, which is offered to all prostate cancer patients. A Pilot Study A pilot study with five participants will be conducted before the intervention starts. The purpose of the pilot study is to test the yoga program. The pilot study will be evaluated through focus groups and individual interviews.
Data Collection Data is collected at baseline, within two months of diagnosis, after 3 and 6 months, and after 1 (and 2) years. An overview of the data collection schedule is shown in Appendix 2a.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •are men diagnosed with prostate cancer without signs of metastatic disease, treated with curative intent. They should be Swedish-speaking and literate. Participants can be included within two months of diagnosis
排除标准
- •are individuals under active surveillance or with advanced disease.
研究组 & 干预措施
Intervention group
Recieves a digital yoga intervention
干预措施: Digital yoga intervention (Other)
Controllgroup
Recieves usual care
结局指标
主要结局
Does internet-based yoga have any effect on stress compared to standard care?
时间窗: From enrollment to 12 months
• The Perceived Stress Scale (PSS)20 measures general stress and coping capacity. The instrument is validated in a Swedish population and has 14 questions. Response options are: almost never, sometimes, fairly often, or very often. The higher the score, the greater the reported stress.
Stress
时间窗: From enrollment to 12 months
The Perceived Stress Scale (PSS)20 measures general stress and coping capacity. The instrument is validated in a Swedish population and has 14 questions. Response options are: almost never, sometimes, fairly often, or very often. The higher the score, the greater the reported stress.
次要结局
未报告次要终点