A Digitally Distributed Yoga Intervention in Prostate Cancer Rehabilitation (DigiYoga-P): Protocol for a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 220
- Locations
- 1
- Primary Endpoint
- Does internet-based yoga have any effect on stress compared to standard care?
Study Overview
Brief Summary
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?
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •are individuals under active surveillance or with advanced disease.
Arms & Interventions
Intervention group
Recieves a digital yoga intervention
Intervention: Digital yoga intervention (Other)
Controllgroup
Recieves usual care
Outcomes
Primary Outcomes
Does internet-based yoga have any effect on stress compared to standard care?
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported