A Yoga Program for Patients Undergoing Prostate Cancer Surgery

NCT ID: NCT05929300

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-18
• Study Completion Date: 2024-09-04

Brief 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.

Detailed Description

Those who are treated with radical prostatectomy (RP) for prostate cancer (PCa) often experience side effects including erectile dysfunction (ED) and urinary incontinence (UI). The side effects of treatment often persist for years and can contribute to anxiety and depression. Yoga, which includes breath work, meditation, and physical poses, may be an effective intervention for treating side effects of RP. To facilitate uptake and maximize its effectiveness, the investigators are initiating the intervention prior to surgery (prehabilitation) and delivering it using a blended approach (i.e., in-person and online sessions).

The proposed intervention is innovative in several ways. First, it applies yoga to a relatively new patient population (men with PCa) and sets of outcomes (ED and UI). Second, the intervention is being tailored to the patient and delivered using a blended model. The first session is in-person and used to tailor the yoga poses according to a Veteran's comfort and ability. Subsequent sessions will take place online alongside ongoing patient cohorts. Third, the intervention includes a prehabilitation component that aims to further dampen the side effects of RP.

The long-term goal of this research is to optimize the QoL and patient experience for men with PCa. To that end, the investigators seek to assess the feasibility of an innovative blended (in-person and online) yoga program and to obtain preliminary data on its potential effectiveness in alleviating PCa treatment symptom burden. The specific aims are to: 1) determine the feasibility (including demand, safety and acceptability) of the intervention for men receiving a radical prostatectomy; and 2) obtain preliminary data to estimate the potential impact of the intervention on ED and UI (primary outcomes), well-being (e.g., cancer fatigue, stress, anxiety), and QoL. Methodology: For this pilot study, 34 Veterans who are undergoing a radical prostatectomy for PCa treatment will be randomized to either the intervention or standard of care. The intervention is a blended twice-weekly yoga program that includes a prehabilitation phase. ED and UI (primary outcomes) as well as mental health well-being (e.g. stress, anxiety), including QoL (secondary outcomes). Program uptake and attrition will be tracked and compared between groups. Baseline and follow-up data on outcomes will be collected via survey. Safety will be closely monitored. Veterans' experiences with and perceptions of the program will be assessed through a post-intervention survey.

Conditions

Prostate Cancer; Erectile Dysfunction; Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Yoga

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 Type: EXPERIMENTAL

Yoga

Intervention Type: BEHAVIORAL

The yoga program includes up to 4 weeks of pre-habilitation yoga and 8 weeks of post-surgery yoga. The yoga program includes basic yoga poses and breathing exercises.

Usual Care

Intervention Type: OTHER

This consists 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.

Usual Care

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.

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: OTHER

This consists 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.

Interventions

Yoga

The yoga program includes up to 4 weeks of pre-habilitation yoga and 8 weeks of post-surgery yoga. The yoga program includes basic yoga poses and breathing exercises.

Intervention Type: BEHAVIORAL

Usual Care

This consists 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.

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Abigail Silva, PhD MPH BA

Role: PRINCIPAL_INVESTIGATOR

Edward Hines Jr. VA Hospital, Hines, IL

Locations

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, United States

Countries

United States

Other Identifiers

PPO 21-225

Identifier Type: -

Identifier Source: org_study_id