Erectile Dysfunction, Prostate Cancer
Conditions
Keywords
15-317
Brief summary
The purpose of this study is to test two different ways to help men with sexual rehabilitation.
Interventions
BEHAVIORALquestionnaires
BEHAVIORALthree in-person sessions
BEHAVIORALmonthly phone calls
BEHAVIORALAcceptance and Commitment Therapy for Erectile Dysfunction (ACT-ED)
BEHAVIORALEnhanced Monitoring and Education (EME)
Sponsors
Memorial Sloan Kettering Cancer Center
Center for Marital and Sexual Health of South Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| percentages of patients having an Erectile Function Domain (EFD) total score >= 24 | 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. |
Countries
United States
Contacts
CONTACTRebecca Saracino, PhD
CONTACTKelly McConnell, PhD
PRINCIPAL_INVESTIGATORRebecca Saracino, PhD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed