Prostate Cancer Clinical Trial
Official title:
Developing and Pilot-testing a Yoga Program to Address Post-prostatectomy Side-effects Among Veterans With Prostate Cancer
Verified date | October 2023 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 34 |
Est. completion date | December 31, 2024 |
Est. primary completion date | September 30, 2024 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | Edward Hines Jr. VA Hospital, Hines, IL | Hines | Illinois |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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. | Through study completion, an average of 16 weeks | |
Secondary | 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. | Change in level of depression from baseline to 4-weeks of pre-habilitation yoga and to 8-weeks of rehabilitation yoga | |
Secondary | 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. | Through study completion, an average of 16 weeks | |
Secondary | 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. | Through study completion, an average of 16 weeks | |
Secondary | 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. | Through study completion, an average of 16 weeks |
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