Therapy for Erectile Dysfunction Adaptation of ACT for Compliance With an Erectile Rehabilitation Program

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Behavioral: Sexual Medicine Rehabilitation Program + nurse practitioner information phone calls; Behavioral: Sexual Medicine Rehabilitation Program + Acceptance and Commitment Therapy for Erectile Dysfunction

• Registration Number: NCT01275404
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-28
• Study First Submitted: 2011-01-11
• Study First Submitted QC: 2011-01-11
• Study First Posted: 2011-01-12
• Status Verified: 2019-07
• Primary Completion: 2019-07-10
• Study Completion: 2019-07-10
• Last Update Submitted: 2019-07-11
• Last Update Posted: 2019-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 99

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
(SMRP) + nurse practitioner information phone calls	Sexual Medicine Rehabilitation Program + nurse practitioner information phone calls	Part A will use focus groups to gain feedback and refine the intervention. Part B will consist of a randomized pilot study where 70 men will be randomly assigned to one of two conditions: Sexual Medicine Rehabilitation (SMRP) plus nurse practitioner information phone calls and monitoring (SMRP+I), or SMRP plus the novel psychological intervention of Acceptance and Commitment Therapy for ED (SMRP+ACT-ED).
SMRP+ACT-ED	Sexual Medicine Rehabilitation Program + Acceptance and Commitment Therapy for Erectile Dysfunction	Part A will use focus groups to gain feedback and refine the intervention. Part B will consist of a randomized pilot study where 70 men will be randomly assigned to one of two conditions: Sexual Medicine Rehabilitation (SMRP) plus nurse practitioner information phone calls and monitoring (SMRP+I), or SMRP plus the novel psychological intervention of Acceptance and Commitment Therapy for ED (SMRP+ACT-ED).

Primary Outcome Measures

Name	Time	Method
To investigate the feasibility	2 years	acceptability, tolerability and adherence) of adapted ACT psychotherapy treatment integrated into an erectile rehabilitation program (i.e., ACT-ED).

Secondary Outcome Measures

Name	Time	Method
To investigate the impact of ACT-ED	2 years	on penile injection compliance, ED treatment satisfaction, sexual functioning, sexual self-esteem, ED bother, depression symptoms, acceptance and self-awareness.

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States