Helping men recover sexual function after prostate cancer surgery
Helping Men Adhere to Sexual Rehabilitation Following Prostate Cancer Surgery
This study tests two different ways to help men regain their sexual function after prostate cancer surgery to see which one works better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 224 (estimated) |
| Ages | 21 Years and up |
| Sex | Male |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT02706561 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate two different approaches to assist men in their sexual rehabilitation following radical prostatectomy for prostate cancer. Participants will engage in three in-person sessions and receive monthly phone calls, utilizing Acceptance and Commitment Therapy for Erectile Dysfunction (ACT-ED) and Enhanced Monitoring and Education (EME) as interventions. The goal is to improve adherence to rehabilitation protocols and enhance sexual functioning post-surgery.
Who should consider this trial
Good fit: Ideal candidates are men who have undergone radical prostatectomy for early-stage prostate cancer and are experiencing moderate erectile dysfunction.
Not a fit: Patients who are not experiencing erectile dysfunction or who are beyond nine months post-surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve sexual rehabilitation outcomes for men recovering from prostate cancer surgery.
How similar studies have performed: Other studies have shown promise in using therapeutic approaches for erectile dysfunction, indicating potential for success in this intervention.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * As per medical record, early stage prostate cancer (Pathologic Stage 1/2 with Gleason score \</=8; or Pathologic Stage 3 with Gleason score =/\< 7) * As per medical record, radical prostatectomy (RP) conducted either at MSKCC or at another institution * As per medical record, ≤ 9 months post-RP * As per medical record, moderate erectile functioning pre-surgery (i.e., 15 or greater on the IIEF Erectile Function Domain (EFD) score, or graded their erections as a 1 or 2 on the standard 5 point Urology Erectile Function scale, or have a score of 6 or greater on the 1-10 pre-surgery erectile function scale on the SMRP assessment or have a total score of 15 or greater on items 2-7 on the Prostrate Quality of Life Survey: Sexual Domain) * As per self report or as per medical record starting penile injections as part of the erectile rehabilitation program at MSKCC * In the judgment of the consenting professional able to communicate, comprehend, and complete questionnaires in English Exclusion Criteria: * Both cavernous nerves fully resected as per surgery report (nerve sparing score of 8 in MSKCC surgeon note), or documented in the progress note that the nerves were fully resected. * Currently on or has a history of being an Androgen Deprivation Therapy (ADT) * Has any indication of Prostate-Specific Antigen (PSA) * As per self report, specific injection phobia * In the judgment of the consenting professional is unable to provide informed consent and complete study sessions and assessment. * As per self report or as documented in the medical record, current untreated (e.g. no medication no therapy) major psychiatric disorder (schizophrenia, major depression). Patients diagnosed with a major psychiatric disorder will be reviewed by the study PI to determine eligibility prior to consent.
Where this trial is running
New York, New York
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Rebecca Saracino, PhD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Rebecca Saracino, PhD
- Email: jamesr@mskcc.org
- Phone: 646-888-0263
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.