Recruiting

Observational Study

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT02706561

Conditions

Prostate Cancer

Erectile Dysfunction

Eligibility Criteria

Sex: Male

Age: 21+

Healthy Volunteers: Not accepted

Interventions

questionnaires

three in-person sessions

monthly phone calls

Acceptance and Commitment Therapy for Erectile Dysfunction (ACT-ED)

Enhanced Monitoring and Education (EME)

Study Details

Brief summary:

The purpose of this study is to test two different ways to help men with sexual rehabilitation.

Conditions

Prostate Cancer

Erectile Dysfunction

Study ID

NCT02706561

Start date

Dec 8, 2015

Status verified date

Apr, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 21+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

224 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Standard care plus the ACT intervention (ACT-ED)

SC + ACT-ED-Group A uses Acceptance and Commitment Therapy (ACT). In this group, men focus on: long-term goals of rehabilitation; acceptance of the frustration related to ED; identifying and overcoming barriers; and committing to an erectile rehabilitation program. All participants will be asked to complete a set of questionnaires (baseline). The participants can complete it using your personal computer, one of MSKCC computers, in-person or over the phone. The questionnaires will take about 45-60 minutes to complete. You will also complete the same set of questionnaires at 6, 12, 18, and 24 months following study entry. In both groups, the participant will receive three in-person sessions or phone (30-45 minutes), six brief telephone sessions (5-10 minutes), and six monthly phone calls (5-10 minutes)

experimental: SC plus nurse Enhanced Monitoring and Education (EME)

SC + EME-Group B uses enhanced monitoring and education. This group focuses on answering questions about the rehabilitation program, manage technical issues related to injections, and the dose titration of injection medication. Participants in this group will also receive education on the side effects and impact of prostate cancer surgery, and strategies for restarting sexual activity. All participants will be asked to complete a set of questionnaires (baseline). You can complete it using your personal computer, one of MSKCC computers, in-person or over the phone. The questionnaires will take about 45-60 minutes to complete. The participant will also complete the same set of questionnaires at 6, 12, 18, and 24 months following study entry. In both groups, the participant will receive three in-person sessions or phone (30-45 minutes), six brief telephone sessions (5-10 minutes), and six monthly phone calls (5-10 minutes).

Interventions

questionnaires

three in-person sessions

monthly phone calls

Acceptance and Commitment Therapy for Erectile Dysfunction (ACT-ED)

Enhanced Monitoring and Education (EME)

Primary outcome measure

  • percentages of patients having an Erectile Function Domain (EFD) total score >= 24 [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Rebecca Saracino, PhD

646-888-0263jamesr@mskcc.org

Kelly McConnell, PhD

646-888-0026McConneK@mskcc.org

Locations

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Rebecca Saracino, PhD

646-888-0263

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Apr 8, 2026

Last verified

Apr, 2026

Keywords

  • 15-317

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-04-08.