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)

Memorial Sloan Kettering Cancer Center

New York, New York, United States

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NCT02706561


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