Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment

Official title

RESTORE-PC: Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment: A Randomized Feasibility Trial

Overview

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.

Detailed description

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.

Interventions

• Behavioral Sex Therapy
  Telehealth sex therapy integrating psychoeducation, acceptance and commitment therapy strategies, and sensate focus skills; 10 sessions (\~45 minutes) over 6 months delivered by a psychologist.
• Behavioral Pelvic Floor Physical Therapy
  Routine clinical survivorship care including pelvic floor assessment, exercises, behavioral strategies for urinary incontinence, and ongoing therapist-guided rehabilitation.
• Device Vacuum Erection Device (VED)
  FDA-cleared manual vacuum pump provided to all participants with education in safe use for penile rehabilitation; not evaluated as an investigational device.

Primary outcome measures

• Recruitment feasibility as measured by number of participants recruited [Time frame: From initiation of recruitment to completion of accrual, up to 1 year]
• Enrollment feasibility, as measured by consent rate [Time frame: From initiation of recruitment to completion of accrual, up to 1 year]
• Randomization feasibility [Time frame: From initiation of recruitment to completion of accrual, up to 1 year]
• Retention feasibility [Time frame: 12 months]
• Number of participants who complete study assessments [Time frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months, 18 Months, 24 Months]
• Number of participants who participate in pelvic floor physical therapy (PFPT) [Time frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months]
• Number of participants who participate in sex therapy [Time frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months]
• Number of participants who use recommended penile rehabilitation [Time frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months]
• Fidelity-monitoring feasibility [Time frame: During the 6-Month sex therapy intervention window]

Secondary outcome measures (12)

• Acceptability of sex therapy, as measured by the Satisfaction with Therapy and Therapist Scale-Revised [Time frame: 6 Months]
• Acceptability of pelvic floor physical therapy, as measured by the Satisfaction with Therapy and Therapist Scale-Revised [Time frame: 12 Months]
• Urinary symptoms and bother, as measured by the International Prostate Symptom Score with bother index/quality of life (IPSS with BI/QOL) [Time frame: 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) [Time frame: 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 [Time frame: 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) [Time frame: Baseline and 12 Months]
• General health status and utility as measured by the PROMIS Global Health [Time frame: Baseline and 12 Months]
• Depressive sympoms as measured by the Patient Health Questionnaire-8 scale [Time frame: Baseline and 12 Months]
• Anxiety symptoms as measured by the Generalized Anxiety Disorder-7 scale [Time frame: Baseline and 12 Months]
• Trauma-related symptoms as measured by Primary Care PTSD Screen [Time frame: Baseline and 12 Months]
• Physical activity, as measured by the International Physical Activity Questionnaire [Time frame: Baseline and 12 Months]
• Continence as measured by Continence Diary - Pad Count [Time frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months, 18 Months, 24 Months]

Eligibility criteria

Inclusion criteria

• 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 17.
• Able to read and understand English to complete patient-reported outcome measures.
• Ability to provide informed consent.

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• Duke University Medical Center — Durham

Identifiers

NCT: NCT07685249 · Pro00119667

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗