Clinical trial NCT01275404: Therapy for Erectile Dysfunction Adaptation of ACT for Compliance With an Erectile Rehabilitation Program
Official title: ACT-ED: Acceptance and Commitment Therapy for Erectile Dysfunction Adaptation of ACT for Compliance With an Erectile Rehabilitation Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Erectile Dysfunction
focus group
Quality of Life
10-204
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Center for Marital and Sexual Health of South Florida
First posted: 2011-01-12
Enrollment: 99
Sex: MALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: To investigate the feasibility
timeFrame: 2 years
Secondary outcomes:
measure: To investigate the impact of ACT-ED
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Christian Nelson, PhD
role: PRINCIPAL_INVESTIGATOR
References: