Helping Men Adhere to Sexual Rehabilitation Following Prostate Cancer Surgery
NCT ID: NCT02706561
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
224 participants
INTERVENTIONAL
2015-12-08
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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)
questionnaires
three in-person sessions
monthly phone calls
Acceptance and Commitment Therapy for Erectile Dysfunction (ACT-ED)
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).
questionnaires
three in-person sessions
monthly phone calls
Enhanced Monitoring and Education (EME)
Interventions
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questionnaires
three in-person sessions
monthly phone calls
Acceptance and Commitment Therapy for Erectile Dysfunction (ACT-ED)
Enhanced Monitoring and Education (EME)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
21 Years
MALE
No
Sponsors
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Center for Marital and Sexual Health of South Florida
OTHER
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Chris Nelson, PhD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Cancer Center
New York, New York, United States
Countries
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Central Contacts
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Christian Nelson, PhD
Role: CONTACT
Andrew Roth, MD
Role: CONTACT
Facility Contacts
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Christian Nelson, PhD
Role: primary
Andrew Roth, MD
Role: backup
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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15-317
Identifier Type: -
Identifier Source: org_study_id
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