A Yoga Program for Patients Undergoing Prostate Cancer Surgery

NCT05929300 | Withdrawn

• 1 other identifier: PPO 21-225
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Erectile Dysfunction; Urinary Incontinence

Keywords

Yoga

Outcome Measures

Primary Outcomes (2)

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

  The 5-item International Index of Erectile Function diagnostic tool was developed in consultation with an international panel of experts for use in determining treatment efficacy in clinical trials. The scores range from 0 to 25 with scores \>21 indicating normal erectile function.

  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

  The 4-item International Consultation on Incontinence Questionnaire-Urinary Incontinence assesses symptoms of incontinence with higher scores indicating more severe symptoms. The scores range from 0 to 21 with scores\>9 depicting very severe impact on daily life activities.

  Through study completion, an average of 16 weeks

Secondary Outcomes (5)

• Change in level of cancer-related fatigue from baseline to 4-weeks of pre-habilitation yoga and to 8-weeks of rehabilitation yoga

  Through study completion, an average of 16 weeks

• depression

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

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

  Through study completion, an average of 16 weeks

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

  Through study completion, an average of 16 weeks

• Change in level of quality of life from baseline to 4-weeks of pre-habilitation yoga and to 8-weeks of rehabilitation yoga

  Through study completion, an average of 16 weeks

Study Arms (2)

Yoga

EXPERIMENTAL

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).

Behavioral: Yoga; Other: Usual Care

Usual Care

ACTIVE COMPARATOR

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.

Other: Usual Care

Interventions

Yoga 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.

Yoga

Usual Care 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; Yoga

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, 60141-3030, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Erectile Dysfunction; Urinary Incontinence

Interventions

Yoga

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Mental Disorders; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Abigail Silva, PhD MPH BA

  Edward Hines Jr. VA Hospital, Hines, IL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: The study design entails randomizing \~34 Veterans who are undergoing radical prostatectomy (RP) for prostate cancer (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). Veterans randomized to the intervention will be asked to routinely practice yoga (at least 15 min/day). 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

Study Record Dates

• First Submitted: June 23, 2023
• First Posted: July 3, 2023
• Study Start: October 18, 2023
• Primary Completion: September 4, 2024
• Study Completion: September 4, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (1)