Developing and Pilot-testing a Yoga Program to Address Post-prostatectomy Side-effects Among Veterans with Prostate Cancer

开发和试点瑜伽项目以解决患有前列腺癌的退伍军人的前列腺切除术后副作用

• 批准号: 10638042
• 负责人: Abigail Silva
• 金额: --
• 依托单位: EDWARD HINES JR VA HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-01 至 2024-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10638042
• 关键词: Address; Age; American; Anxiety; Awareness; Bladder Control; Blood flow; Cancer Fatigue; Cancer Patient; Cancer Survivor; Caring; Complementary Health; Data; Diagnosis; Effectiveness; Effectiveness of Interventions; Erectile dysfunction; Fatigue; Financial Hardship; Goals; Habilitation; Health; Health Services Research; Healthcare Systems; Hybrids; Iatrogenesis; Integrative Medicine; Intervention; Length; Life Style Modification; Malignant Neoplasms; Malignant neoplasm of prostate; Meditation; Mental Depression; Mental Health; Methodology; Mind-Body Intervention; Modality; Modeling; Monitor; Operative Surgical Procedures; Outcome; Pain; Patients; Pelvic Floor Muscle; Pelvic floor structure; Perception; Personal Satisfaction; Persons; Pharmaceutical Preparations; Phase; Pilot Projects; Population; Program Development; Prostate Cancer therapy; Prostatectomy; Quality of life; Radical Prostatectomy; Randomized; Reporting; Research; Safety; Schedule; Self Management; Stress; Surveys; Symptoms; Transportation; Travel; Treatment Efficacy; Treatment Side Effects; Urinary Incontinence; Veterans; Veterans Health Administration; Visit; Woman; Work; Yoga; cancer care; cancer diagnosis; cancer therapy; cohort; comorbidity; effective intervention; efficacy evaluation; experience; follow-up; improved; innovation; malignant breast neoplasm; men; patient population; pilot test; post intervention; primary outcome; programs; prostate cancer survivors; reduce symptoms; secondary outcome; side effect; standard of care; symptom management; symptom treatment; targeted treatment; uptake; virtual; whole health

Background: Prostate cancer (PCa) constitutes 30% of all new cancer diagnoses in the Veterans Health Administration (VHA) and as such is the most frequently treated cancer among Veterans. Those who are treated with radical prostatectomy (RP) 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, we propose to initiate the intervention prior to surgery (prehabilitation) and deliver it using a blended approach (i.e., in-person and online sessions). Significance/Impact: The VHA provides care to half a million cancer survivors, of which nearly half are PCa survivors. This number is expected to grow as the population ages and treatments become more effective. It is therefore critical for the VHA to understand how best to enhance the quality and length of survival of those diagnosed with cancer. Furthermore, the VHA and Health Services Research and Development program recognize the importance of using a “Whole Health” approach to supporting the health and well-being of Veterans. This intervention aligns with the purpose of Whole Health by partnering with Veterans to create a personalized yoga plan based on their own goals and needs. Innovation: 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. Specific Aims: The long-term goal of this research is to optimize the QoL and patient experience for men with PCa. To that end, we 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, 30 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 programs will be assessed through a post-intervention survey. Next Steps/Implementation: We anticipate that the intervention will be feasible, safe, and acceptable to Veterans and provide some evidence of potential efficacy. Subsequently, we intend to fully evaluate the efficacy of the intervention while exploring its broader adaptation in VHA.

背景：前列腺癌（PCa）占美国所有新诊断癌症的30%