WithdrawnNot Applicable

A Yoga Program for Patients Undergoing Prostate Cancer Surgery

Stopped: Lack of recruitment

United States0Started 2023-10-18

Plain-language summary

Men with localized prostate cancer (PCa) are often treated with surgery, a treatment that is associated with high rates of side effects such as erectile dysfunction (ED) and urinary incontinence (UI) which impact quality of life. Yoga may improve control of UI and improve ED by bringing awareness to and strengthening the pelvic floor musculature. The randomized controlled pilot study is to assess the feasibility of an innovative hybrid (in-person and virtual) twice-weekly yoga program that includes a prehabilitation component and to obtain preliminary data that will help assess its potential effectiveness in alleviating PCa treatment symptom burden (primarily ED and UI). The long-term goal is to develop a scalable and sustainable yoga program that helps cancer survivors manage their treatment side effects.

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * patients must be age 18 year or older * have a biopsy-proven diagnosis of localized prostate cancer * scheduled to undergo robotic-assisted or open radical prostatectomy * speak English * willing and able to attend an in-person yoga session at Hines VA * possess hardware and internet connectivity that will enable participation in virtual yoga classes Exclusion Criteria: * patients will be excluded if currently participating in yoga practice (twice weekly in past three months) and have any of the following conditions: * neurogenic bladder * (uncontrolled/major) cardiac arrhythmia * psychosis * cognitive impairment * patients will be excluded if they are planning to move outside of the Chicago area * unable to participate in low- to moderate-intensity physical activity * currently experiencing issues around substance abuse (not including prescription opioids)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in level of erectile dysfunction from baseline to 4-weeks of pre-habilitation yoga and to 8-weeks of rehabilitation yoga

Timeframe: Through study completion, an average of 16 weeks

Change in level of urinary incontinence from baseline to 4-weeks of pre-habilitation yoga and to 8-weeks of rehabilitation yoga

Timeframe: Through study completion, an average of 16 weeks

Trial details

NCT IDNCT05929300

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2024-09-04

View on ClinicalTrials.gov More Prostate Cancer trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in level of erectile dysfunction from baseline to 4-weeks of pre-habilitation yoga and to 8-weeks of rehabilitation yoga

Timeframe: Through study completion, an average of 16 weeks

Change in level of urinary incontinence from baseline to 4-weeks of pre-habilitation yoga and to 8-weeks of rehabilitation yoga

Timeframe: Through study completion, an average of 16 weeks