RecruitingNot ApplicableNCT02706561
Helping Men Adhere to Sexual Rehabilitation Following Prostate Cancer Surgery
Sponsor
Memorial Sloan Kettering Cancer Center
Enrollment
224 participants
Start Date
Dec 8, 2015
Study Type
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to test two different ways to help men with sexual rehabilitation.
Eligibility
Sex: MALEMin Age: 21 Years
Inclusion Criteria6
- 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 Criteria6
- 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.
Interventions
BEHAVIORALquestionnaires
BEHAVIORALthree in-person sessions
BEHAVIORALmonthly phone calls
BEHAVIORALAcceptance and Commitment Therapy for Erectile Dysfunction (ACT-ED)
BEHAVIORALEnhanced Monitoring and Education (EME)
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT02706561
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