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Behavioral Intervention

Yoga Program for Prostate Cancer

N/A
Waitlist Available
Led By Abigail Silva, PhD MPH BA
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Scheduled to undergo robotic-assisted or open radical prostatectomy
Patients must be age 18 year or older
Must not have
Patients 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
Unable to participate in low- to moderate-intensity physical activity
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change in level of depression from baseline to 4-weeks of pre-habilitation yoga and to 8-weeks of rehabilitation yoga
Awards & highlights

Summary

This trial will assess if yoga can improve side effects from prostate cancer treatment, like ED and UI, and help cancer survivors manage their treatment side effects.

Who is the study for?
This trial is for men over 18 with localized prostate cancer who are about to have surgery. They must speak English, be able to attend yoga sessions in person and online, and not currently practice yoga regularly. Men with certain medical conditions or substance abuse issues cannot join.Check my eligibility
What is being tested?
The study tests a hybrid yoga program designed to help manage side effects from prostate cancer surgery, like erectile dysfunction and urinary incontinence. Participants will do yoga twice weekly before and after their surgery, both virtually and in-person.See study design
What are the potential side effects?
Yoga is generally safe but may include mild discomfort or muscle strain. Since it's low- to moderate-intensity exercise, risks are minimal compared to drug treatments; however, individuals should consider their physical limitations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for a major prostate surgery using a robot or traditional method.
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I am 18 years old or older.
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My prostate cancer diagnosis was confirmed with a biopsy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I practice yoga twice a week and have a condition like neurogenic bladder, severe heart rhythm problems, psychosis, or cognitive issues.
Select...
I cannot do light to moderate exercise.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change in level of depression from baseline to 4-weeks of pre-habilitation yoga and to 8-weeks of rehabilitation yoga
This trial's timeline: 3 weeks for screening, Varies for treatment, and change in level of depression from baseline to 4-weeks of pre-habilitation yoga and to 8-weeks of rehabilitation yoga for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in level of erectile dysfunction from baseline to 4-weeks of pre-habilitation yoga and to 8-weeks of rehabilitation yoga
Change in level of urinary incontinence from baseline to 4-weeks of pre-habilitation yoga and to 8-weeks of rehabilitation yoga
Secondary outcome measures
Change in level of anxiety from baseline to 4-weeks of pre-habilitation yoga and to 8-weeks of rehabilitation yoga
Change in level of cancer-related fatigue from baseline to 4-weeks of pre-habilitation yoga and to 8-weeks of rehabilitation yoga
Change in level of quality of life from baseline to 4-weeks of pre-habilitation yoga and to 8-weeks of rehabilitation yoga
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: YogaExperimental Treatment2 Interventions
The study design entails randomizing ~34 Veterans who are undergoing RP for PCa to either usual care or a twice-weekly hybrid (in-person and virtual) yoga program that includes up to 4 weeks of pre-habilitation yoga and 8 weeks of post-RP yoga. Participants will provide data at three time points: baseline/pre-yoga (T1), completion of~ 4 weeks of pre-RP yoga (T2), and completion of 8 weeks of post-RP yoga (T3). Data collection for the control group will parallel that of the yoga group. Times of data collection are consistent with other yoga trials. Veterans randomized to the intervention will be asked to routinely practice yoga (at least 15 min/day).
Group II: Usual CareActive Control1 Intervention
The control group will consist of "usual care" patients. It is current practice for all patients to: 1) receive a handout that covers Kegel exercises; and, 2) instruction from a nurse who teaches the patient how to perform the exercises. There is no referral to a physical therapist unless progression indicates a need for it.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Yoga
2008
Completed Phase 3
~3830

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,628 Previous Clinical Trials
3,325,945 Total Patients Enrolled
4 Trials studying Urinary Incontinence
749 Patients Enrolled for Urinary Incontinence
Abigail Silva, PhD MPH BAPrincipal InvestigatorEdward Hines Jr. VA Hospital, Hines, IL

Media Library

Yoga (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05929300 — N/A
Urinary Incontinence Research Study Groups: Usual Care, Yoga
Urinary Incontinence Clinical Trial 2023: Yoga Highlights & Side Effects. Trial Name: NCT05929300 — N/A
Yoga (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05929300 — N/A
~6 spots leftby Sep 2024
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