Therapy for Erectile Dysfunction Adaptation of ACT for Compliance With an Erectile Rehabilitation Program
This trial is active, not recruiting.
|Treatments||sexual medicine rehabilitation program + nurse practitioner information phone calls, sexual medicine rehabilitation program + acceptance and commitment therapy for erectile dysfunction|
|Sponsor||Memorial Sloan Kettering Cancer Center|
|Collaborator||National Institutes of Health (NIH)|
|Start date||December 2010|
|End date||December 2017|
|Trial size||110 participants|
|Trial identifier||NCT01275404, 10-204|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
To investigate the feasibility
time frame: 2 years
To investigate the impact of ACT-ED
time frame: 2 years
Male participants at least 21 years old.
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.
|Official title||ACT-ED: Acceptance and Commitment Therapy for Erectile Dysfunction Adaptation of ACT for Compliance With an Erectile Rehabilitation Program|
|Principal investigator||Christian Nelson, PhD|
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