Helping Men Adhere to Sexual Rehabilitation Following Prostate Cancer Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age21+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
The purpose of this study is to test two different ways to help men with sexual rehabilitation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
questionnaires
Behavioralthree in-person sessions
Behavioralmonthly phone calls
BehavioralAcceptance and Commitment Therapy for Erectile Dysfunction (ACT-ED)
BehavioralEnhanced Monitoring and Education (EME)
Behavioral
Treatment groups
224 Participants
are divided into 2 treatment groupsGroup A: Standard care plus the ACT intervention (ACT-ED)Experimental treatment 4 interventions
Group B: SC plus nurse Enhanced Monitoring and Education (EME)Experimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
percentages of patients having an Erectile Function Domain (EFD) total score >= 24
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.
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Memorial Sloan Kettering Cancer Center
Lead sponsor
Center for Marital and Sexual Health of South Florida
Collaborator
Source ClinicalTrials.gov