Prostate CancerNCT05929300
A Yoga Program for Patients Undergoing Prostate Cancer Surgery
A study testing Yoga in people with Prostate Cancer and Erectile Dysfunction, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Erectile Dysfunction, Urinary Incontinence
- What is being tested?
- Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2023to 4 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, 60141-3030
About this study
Official title: Developing and Pilot-testing a Yoga Program to Address Post-prostatectomy Side-effects Among Veterans With Prostate Cancer
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.
Read the 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
- Being tested
- Yoga, Usual Care
- Keywords
- Yoga
- Medical subject headings
- Prostatic Neoplasms, Erectile Dysfunction, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaBehavioural
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 CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
The 9-item Brief Fatigue Inventory questionnaire can assess fatigue severity. Each item ranges from 0-10 with values >7 denoting severe interference with daily life activities.
Measured: Through study completion, an average of 16 weeks
depression
The Patient Health Questionnaire (PHQ-9) provides a brief measure of depression severity (i.e., mild, moderate, moderately severe, and severe) over the past two weeks. The scores range from 0 to 27 with scores>19 depicting severe depression.
Measured: 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
The Generalized Anxiety Disorder 7-item instrument (GAD-7) measures the level of anxiety with a score of 10 or more (out of a total score of 21) indicating clinically significant anxiety.
Measured: 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
The Perceived Stressor Scale is a 10-item questionnaire that assesses the degree to which one finds life unpredictable, uncontrollable or overloaded over the past month. The scores range from 0 to 40 with scores>26 depicting high perceived stress.
Measured: 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
Quality of life will be evaluated via the Functional Assessment of Cancer Therapy questionnaire for patients with PCa (FACT-P). Total scores range from 0 to 104 with higher scores denoting higher quality of life.
Measured: Through study completion, an average of 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start18 Oct 2023
- Primary completion4 Sep 2024
- Study completion4 Sep 2024
Why it stopped: Lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Abigail Silva, PhD MPH BA, Principal investigator, Edward Hines Jr. VA Hospital, Hines, IL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05929300
- Sponsor's protocol ID
- PPO 21-225
- Status last verified
- Sep 2024
- First submitted
- 23 Jun 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will use the Safe Harbor Method to de-identify the data set include a limited set of the most relevant variables to help ensure that patient confidentiality and privacy is maintained. The VHA privacy officer will certify whether the data set meet conditions for disclosure to the public. Final data sets will be maintained locally. Guidance on request and distribution processes will be provided by Office of Research and Development. Data users will have to sign a Data Use Agreement in compliance with privacy regulations.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Pilot-testing a Yoga Program to Address Post-prostatectomy Side-effects Among Veterans With Prostate Cancer
- ClinicalTrials.gov ID
- NCT05929300
- Acronym / sponsor ID
- PPO 21-225
- Conditions
- Prostate Cancer, Erectile Dysfunction, Urinary Incontinence
- Keywords
- Yoga
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 18 Oct 2023 (actual)
- Primary completion
- 4 Sep 2024 (actual)
- Study completion
- 4 Sep 2024 (actual)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Yoga | Experimental | Behavioral: Yoga, Other: Usual CareThe 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). |
| Usual Care | Active comparator | Other: Usual CareThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- patients will be excluded if currently participating in yoga practice (twice weekly in past three months) and have any of the following conditions:
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YogaThe 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. | Behavioural | Yoga |
| Usual CareThis 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. | Other | Usual Care, Yoga |
Primary outcome
Change in level of erectile dysfunction from baseline to 4-weeks of pre-habilitation yoga and to 8-weeks of rehabilitation yoga
Time frame: Through study completion, an average of 16 weeks
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.
Change in level of urinary incontinence from baseline to 4-weeks of pre-habilitation yoga and to 8-weeks of rehabilitation yoga
Time frame: Through study completion, an average of 16 weeks
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.
5 secondary outcomes
Change in level of cancer-related fatigue from baseline to 4-weeks of pre-habilitation yoga and to 8-weeks of rehabilitation yoga
Time frame: Through study completion, an average of 16 weeks
depression
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Through study completion, an average of 16 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Yes. We will use the Safe Harbor Method to de-identify the data set include a limited set of the most relevant variables to help ensure that patient confidentiality and privacy is maintained. The VHA privacy officer will certify whether the data set meet conditions for disclosure to the public. Final data sets will be maintained locally. Guidance on request and distribution processes will be provided by Office of Research and Development. Data users will have to sign a Data Use Agreement in compliance with privacy regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abigail Silva, PhD MPH BA principal investigator
Edward Hines Jr. VA Hospital, Hines, IL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga in people with Prostate Cancer and Erectile Dysfunction, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in level of erectile dysfunction from baseline to 4-weeks of pre-habilitation yoga and to 8-weeks of rehabilitation yoga (time frame: Through study completion, an average of 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024; AzTrials last refreshed its copy on 30 Oct 2026.