- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02706561
Helping Men Adhere to Sexual Rehabilitation Following Prostate Cancer Surgery
January 4, 2024 updated by: Memorial Sloan Kettering Cancer Center
The purpose of this study is to test two different ways to help men with sexual rehabilitation.
Study Overview
Status
Recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
224
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Christian Nelson, PhD
- Phone Number: 646-888-0030
Study Contact Backup
- Name: Andrew Roth, MD
- Phone Number: 646-888-0024
Study Locations
-
-
New York
-
New York, New York, United States, 10065
- Recruiting
- Memorial Sloan Kettering Cancer Center
-
Contact:
- Christian Nelson, PhD
- Phone Number: 646-888-0030
-
Contact:
- Andrew Roth, MD
- Phone Number: 646-888-0024
-
Principal Investigator:
- Christian Nelson, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
percentages of patients having an Erectile Function Domain (EFD) total score >= 24
Time Frame: 1 year
|
The EFD score of >= 24 will be used to indicate "good" erectile function.
This is both a face valid cut-off, and a cut off that is commonly used in the literature as "good" erectile function following radical prostatectomy.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Chris Nelson, PhD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 8, 2015
Primary Completion (Estimated)
December 1, 2025
Study Completion (Estimated)
December 1, 2025
Study Registration Dates
First Submitted
March 3, 2016
First Submitted That Met QC Criteria
March 7, 2016
First Posted (Estimated)
March 11, 2016
Study Record Updates
Last Update Posted (Actual)
January 5, 2024
Last Update Submitted That Met QC Criteria
January 4, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Sexual Dysfunctions, Psychological
- Sexual Dysfunction, Physiological
- Urogenital Diseases
- Male Urogenital Diseases
- Genital Diseases, Male
- Genital Diseases
- Prostatic Neoplasms
- Erectile Dysfunction
Other Study ID Numbers
- 15-317
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Erectile Dysfunction
-
University of VirginiaActive, not recruitingErectile Dysfunction | Erectile Dysfunction Following Radical Prostatectomy | Erectile Dysfunction Following Radiation Therapy | Erectile Dysfunction Due to General Medical Condition | Erectile Dysfunction Due to Arterial InsufficiencyUnited States
-
Cairo UniversityRecruitingErectile Dysfunction | Erectile Dysfunction Following Radical Prostatectomy | Erectile Dysfunction Following Simple Prostatectomy | Erectile Dysfunction With Diabetes Mellitus | Erectile Dysfunction Due to Arterial Disease | Erectile Dysfunction Due to Injury | Erectile Dysfunction Due to Neuropathy and other conditionsEgypt
-
University of BaghdadCompletedSexual Dysfunction | Erectile Dysfunction | Erectile Dysfunction Following Radical Prostatectomy | Erectile Dysfunction Following Radiation Therapy | Sexual Abstinence | Erectile Dysfunction With Diabetes Mellitus | Sexual Desire Disorder | Erectile Dysfunction Following Cryotherapy | Erectile Dysfunction... and other conditionsIraq
-
Cairo UniversityCompletedVasculogenic Erectile DysfunctionEgypt
-
InitiaTerminatedVasculogenic Erectile DysfunctionIsrael
-
InitiaCompletedVasculogenic Erectile DysfunctionIsrael
-
InitiaCompletedVasculogenic Erectile DysfunctionCzech Republic, Lithuania, Netherlands, Palestinian Territories, Occupied
-
Rexahn Pharmaceuticals, Inc.CompletedErectile Dysfunction (ED)United States
-
SK Chemicals Co., Ltd.TerminatedMale Erectile Dysfunction
-
BayerCompletedSexual Dysfunction | Male Erectile DysfunctionBelgium, Italy, France, Germany, Spain, Netherlands, South Africa
Clinical Trials on questionnaires
-
Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI); National Institutes of Health (NIH)Completed
-
Direction Centrale du Service de Santé des ArméesCompleted
-
Sun Yat-sen UniversityNot yet recruiting
-
Assistance Publique - Hôpitaux de ParisRecruitingIntensive Care Unit Syndrome | Pediatric Post-intensive Care SyndromeFrance
-
University Hospital, GrenobleUniversity Grenoble AlpsNot yet recruitingChildhood Cancer | Adapted Physical ActivityFrance
-
M.D. Anderson Cancer CenterCompletedAdvanced Cancer | Malignant Neoplasms of Independent (Primary) Multiple SitesUnited States
-
The University of Hong KongCompleted
-
Centre Hospitalier Universitaire DijonCompleted
-
Cliniques universitaires Saint-Luc- Université...Fonds National de la Recherche ScientifiqueNot yet recruitingAlcohol Use Disorder
-
Memorial Sloan Kettering Cancer CenterIcahn School of Medicine at Mount Sinai; Hackensack Meridian Health; Derald H...CompletedLeukemia | Multiple Myeloma | Non-Hodgkin's Lymphoma | Hodgkin's DiseaseUnited States