Prostate Cancer Clinical Trial
— ACT-EDOfficial title:
ACT-ED: Acceptance and Commitment Therapy for Erectile Dysfunction Adaptation of ACT for Compliance With an Erectile Rehabilitation Program
NCT number | NCT01275404 |
Other study ID # | 10-204 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | December 28, 2010 |
Est. completion date | July 10, 2019 |
Verified date | July 2019 |
Source | Memorial Sloan Kettering Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators know that treatment for prostate cancer and erectile dysfunction can impact
sexual health and quality of life. They want to learn how the treatment affects one's
emotional and social well-being.
They have developed a new type of counseling. Cancer patients seek counseling for lots of
reasons. It often helps them cope because they can express their feelings with a trained
professional. They hope that this counseling will teach patients skills that they can use to
comply with erectile treatment programs, improve their sexual health and quality of life.
These skills may also improve physical and emotional well-being. As part of this study they
will ask the patient to provide feedback on the proposed counseling.
Status | Completed |
Enrollment | 99 |
Est. completion date | July 10, 2019 |
Est. primary completion date | July 10, 2019 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 21 Years and older |
Eligibility |
Inclusion Criteria: Part A - Men who are 1 to 3 years post radical prostatectomy for early stage prostate cancer - Participated in penile injection program - Are able to speak, read, write and understand English well enough to complete study assessment and communicate with an English speaking therapist Part B - Men who are up to 9 months post radical prostatectomy. - Had good erectile functioning pre-surgery (i.e., 24 or greater on the IIEF Erectile Function Domain (EFD) score), graded their erections as a 1 or 2 on the standard 5 point Urology Erectile Function scale) or have a score of 7 or greater on the 1-10 pre-surgery erectile function scale on the SMRP assessment) - Seen at MSKCC?s Sexual Medicine Rehabilitation Program (SMRP) - Advised by the clinical staff of the SMRP to start penile injections. Exclusion Criteria: Part A - Recurrence or progression of disease, - Specific injection phobia (self report) - A history of bipolar disorder or psychotic disorder (determined from self-report and/or chart review) - Current major depression (determined by self report and/or clinician observation and assessment) that would preclude from giving informed consent or being an active participant in a focus group Part B - Specific injection phobia (self report) - A history of bipolar disorder or psychotic disorder (determined from self-report and/or chart review) - Current major depression (determined by self report and/or clinician observation and assessment) that would preclude from giving informed consent or being an active participant in a therapeutic session. |
Country | Name | City | State |
---|---|---|---|
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Memorial Sloan Kettering Cancer Center | Center for Marital and Sexual Health of South Florida, National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To investigate the feasibility | acceptability, tolerability and adherence) of adapted ACT psychotherapy treatment integrated into an erectile rehabilitation program (i.e., ACT-ED). | 2 years | |
Secondary | To investigate the impact of ACT-ED | on penile injection compliance, ED treatment satisfaction, sexual functioning, sexual self-esteem, ED bother, depression symptoms, acceptance and self-awareness. | 2 years |
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