RESTORE-PC: Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment: A Randomized Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Recruitment feasibility as measured by number of participants recruited
研究概览
简要总结
This study is being done at Duke Health and includes adult men who have been treated for localized prostate cancer. The goal is to see if it is feasible and acceptable to offer sex therapy by telehealth after prostate cancer treatment.
All participants receive pelvic floor physical therapy and education about penile rehabilitation, including use of a vacuum erection device. Participants are randomly assigned to one of two groups. One group receives pelvic floor physical therapy plus telehealth sex therapy, with about ten sessions over six months. The other group receives pelvic floor physical therapy alone.
Participants complete questionnaires about urinary and sexual health at the start of the study and over the next two years. Short interviews are also done at 6 and 12 months. Medicines for erectile function are prescribed as part of usual clinical care and are not part of the study treatment.
详细描述
This is a two-arm, parallel-group, randomized feasibility trial conducted at Duke University Health System. Eligible adult men treated for localized prostate adenocarcinoma with erectile nerve-sparing radical prostatectomy, radiotherapy, or cryoablation at Duke Health who are initiating pelvic floor physical therapy (PFPT) will be randomized 1:1 to PFPT plus sex therapy or PFPT alone. PFPT is delivered as part of routine clinical survivorship care. All enrolled participants will receive penile rehabilitation education and a vacuum erection device (VED) as part of standard PFPT, in addition to clinician-prescribed PDEi if applicable.
The sex therapy intervention is delivered by telehealth as 10 sessions of approximately 45 minutes over 6 months. Baseline assessment occurs after completion of localized treatment and before initiation of study-linked rehabilitation.
Patient-reported outcome measures will be collected at baseline and at 3, 6, 9, 12, 18, and 24 months post-baseline for feasibility of longer follow-up. Semi-structured qualitative interviews will be offered at 6 and 12 months post-baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older.
- •Biopsy-confirmed localized prostate adenocarcinoma.
- •Treated with nerve-sparing radical prostatectomy, radiotherapy, or cryoablation as primary index therapy for prostate cancer at Duke Health.
- •Initiating pelvic floor physical therapy as part of routine clinical care.
- •Pre-treatment International Index of Erectile Function-5 (IIEF-5) score meeting the eligibility threshold, with or without aids, determined by medical record chart review (when documented within 4 months prior to index treatment) or collected post-treatment with participant recall anchored to the month prior to treatment. Eligibility threshold for the IIEF-5 is at or above
- •Able to read and understand English to complete patient-reported outcome measures.
- •Ability to provide informed consent.
排除标准
- •Any androgen deprivation therapy (ADT) given for prostate cancer treatment or planned during the intervention or follow-up period, including neoadjuvant, concurrent, or adjuvant ADT.
- •Recieved non-nerve-sparing treatment (when applicable).
- •Unable to engage in pelvic floor physical therapy or penile rehabilitation protocol.
- •Need for additional or secondary prostate cancer treatment during the intervention period.
- •Documented cognitive impairment or impairment that would interfere with participation.
- •Major psychiatric concern that would interfere with ability to consent or participate, such as schizophrenia, based on the medical record or treating clinician assessment.
- •Inability to complete study video visits or questionnaires.
- •History of prior local or systemic treatment for prostate cancer
研究组 & 干预措施
PFPT Alone (Standard Care)
Standard pelvic floor physical therapy and penile rehabilitation education (including provision of VED); no study-delivered sex therapy.
干预措施: Vacuum Erection Device (VED) (Device)
PFPT Alone (Standard Care)
Standard pelvic floor physical therapy and penile rehabilitation education (including provision of VED); no study-delivered sex therapy.
干预措施: Pelvic Floor Physical Therapy (Behavioral)
PFPT + Sex Therapy
Ten 45-minute telehealth sex therapy sessions over 6 months plus standard pelvic floor physical therapy and penile rehabilitation education (including provision of VED).
干预措施: Pelvic Floor Physical Therapy (Behavioral)
PFPT + Sex Therapy
Ten 45-minute telehealth sex therapy sessions over 6 months plus standard pelvic floor physical therapy and penile rehabilitation education (including provision of VED).
干预措施: Vacuum Erection Device (VED) (Device)
PFPT + Sex Therapy
Ten 45-minute telehealth sex therapy sessions over 6 months plus standard pelvic floor physical therapy and penile rehabilitation education (including provision of VED).
干预措施: Sex Therapy (Behavioral)
结局指标
主要结局
Recruitment feasibility as measured by number of participants recruited
时间窗: From initiation of recruitment to completion of accrual, up to 1 year
Accrual rate will be used to assess feasibility of recruiting participants to the study target of 30 participants. This feasibility trial is designed to estimate key process parameters with precision rather than to test efficacy hypotheses
Enrollment feasibility, as measured by consent rate
时间窗: From initiation of recruitment to completion of accrual, up to 1 year
Consent rate will be used to assess enrollment feasibility. This measure reflects the proportion of eligible participants who provide informed consent after screening and outreach.
Randomization feasibility
时间窗: From initiation of recruitment to completion of accrual, up to 1 year
Randomization rate will be used to assess the proportion of consented eligible participants who are randomized in a 1:1 ratio to pelvic floor physical therapy (PFPT) plus sex therapy or PFPT alone.
Retention feasibility
时间窗: 12 months
Retention will be used to assess the proportion of randomized participants who remain in the study through the 12-month follow-up timepoint.
Number of participants who complete study assessments
时间窗: Baseline, 3 Months, 6 Months, 9 Months, 12 Months, 18 Months, 24 Months
Assessment completion will be used to assess feasibility of longitudinal data collection across the planned study schedule. Scheduled patient-reported outcome assessments occur at baseline and during follow-up contacts.
Number of participants who participate in pelvic floor physical therapy (PFPT)
时间窗: Baseline, 3 Months, 6 Months, 9 Months, 12 Months
Intervention exposure metrics will be used to assess feasibility of delivering and receiving the rehabilitation pathway. This includes participation in PFPT.
Number of participants who participate in sex therapy
时间窗: Baseline, 3 Months, 6 Months, 9 Months, 12 Months
Intervention exposure metrics will be used to assess feasibility of delivering and receiving the rehabilitation pathway. This includes sex therapy participation in the intervention arm.
Number of participants who use recommended penile rehabilitation
时间窗: Baseline, 3 Months, 6 Months, 9 Months, 12 Months
Intervention exposure metrics will be used to assess feasibility of delivering and receiving the rehabilitation pathway. This includes recommended penile rehabilitation use patterns including vacuum erection device (VED) and PDE-5i use as measured via adherence logs.
Fidelity-monitoring feasibility
时间窗: During the 6-Month sex therapy intervention window
Fidelity-monitoring feasibility will be assessed using audio recording of sex therapy sessions and audit of a planned 20% sample of recordings using fidelity checklists.
次要结局
- Acceptability of sex therapy, as measured by the Satisfaction with Therapy and Therapist Scale-Revised(6 Months)
- Acceptability of pelvic floor physical therapy, as measured by the Satisfaction with Therapy and Therapist Scale-Revised(12 Months)
- Urinary symptoms and bother, as measured by the International Prostate Symptom Score with bother index/quality of life (IPSS with BI/QOL)(Baseline, 3 Months, 6 Months, 9 Months, 12 Months, 18 Months, 24 Months)
- Erectile dysfunction as measured by the International Index of Erectile Function-5 (IIEF-5)(Baseline, 3 Months, 6 Months, 9 Months, 12 Months, 18 Months, 24 Months)
- Sexual function and satisfaction as measured by the PROMIS Sexual Function and Satisfaction Male Brief Profile(Baseline, 3 Months, 6 Months, 9 Months, 12 Months, 18 Months, 24 Months)
- General health status and utility as measured by the PROMIS-16 Profile v2.1 (PROPr)(Baseline and 12 Months)
- General health status and utility as measured by the PROMIS Global Health(Baseline and 12 Months)
- Depressive sympoms as measured by the Patient Health Questionnaire-8 scale(Baseline and 12 Months)
- Anxiety symptoms as measured by the Generalized Anxiety Disorder-7 scale(Baseline and 12 Months)
- Trauma-related symptoms as measured by Primary Care PTSD Screen(Baseline and 12 Months)
- Physical activity, as measured by the International Physical Activity Questionnaire(Baseline and 12 Months)
- Continence as measured by Continence Diary - Pad Count(Baseline, 3 Months, 6 Months, 9 Months, 12 Months, 18 Months, 24 Months)
- Use of medications and sexual aids as measured by Medication and Sexual Aids Inventory and Use Log(Baseline, 3 Months, 6 Months, 9 Months, 12 Months, 18 Months, 24 Months)
- Adherence and Barriers to Adherence(Baseline and 12 Months)
- PDE5 inhibitor medication adherence, as measured by Screening Tool for AdheRence to medicineS (15-STARS ED)(Baseline, 3 Months, 6 Months, 9 Months, 12 Months)
- Sexual avoidance as measured by a Sexual Avoidance Questionnaire(Baseline and 12 Months)
- Sexual self-efficacy as measured by the Sexual Self-Efficacy Questionnaire(Baseline and 12 Months)
- Sexual satisfaction as measured by a Sexual Satisfaction Questionnaire(Baseline and 12 Months)
- Sexual dysfunction as measured by a Sexual Dysfunction Questionnaire(Baseline and 12 Months)
- Sexual health information and support needs(Baseline and 12 Months)
- Patient perceptions and opinions about guidelines(Baseline and 12 Months)