RECRUITING

Helping Men Adhere to Sexual Rehabilitation Following Prostate Cancer Surgery

Conditions

Prostate Cancer Erectile Dysfunction 15-317

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Helping Men Adhere to Sexual Rehabilitation Following Prostate Cancer Surgery

Quick Facts

Study Start:2015-12-08

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT02706561

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.

Ages Eligible for Study:21 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Study Contact

Christian Nelson, PhD

CONTACT

646-888-0030

Andrew Roth, MD

CONTACT

646-888-0024

Principal Investigator

Chris Nelson, PhD

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

Chris Nelson, PhD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

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 Registration Dates

Study Start Date2015-12-08

Study Completion Date2025-12

Study Record Updates

Study Start Date2015-12-08

Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

15-317

Additional Relevant MeSH Terms

Prostate Cancer
Erectile Dysfunction