Overview

This trial is active, not recruiting.

Condition prostate cancer
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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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).
sexual medicine rehabilitation program + nurse practitioner information phone calls
Baseline Assessment which is 90-minute patient focus group interviews. SMRP, provided to all participating patients, consists of the following steps: 1) An introductory visit with SMRP Director, Dr. Mulhall, to orient the patient to post-surgery erectile rehabilitation and assess the patient‟s success with PDE-5 inhibitors; 2) Penile injection training provided by a NP over two visits, with follow-up calls as necessary until injection method and dose are deemed correct; 3) Follow-up visits with Dr. Mulhall every 4 months to monitor progress with rehabilitation. Study assessments will be administered at baseline, at 4-8 months post baseline (follow up 1) and 4-8- months post follow up 1 (follow up 2).
(Experimental)
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).
sexual medicine rehabilitation program + acceptance and commitment therapy for erectile dysfunction
Baseline Assessment which is 90-minute patient focus group interviews. SMRP+ACT-ED will receive four individual ACT-ED counseling sessions (60 minutes each) over a period of approximately four months, and will also be followed up with questionnaires 4 and 8 months post baseline These sessions focus on the four core elements of ACT: values, acceptance, exposure, and commitment. Study assessments will be administered at baseline, at 4-8 months post baseline (follow up 1) and 4-8- months post follow up 1 (follow up 2).

Primary Outcomes

Measure
To investigate the feasibility
time frame: 2 years

Secondary Outcomes

Measure
To investigate the impact of ACT-ED
time frame: 2 years

Eligibility Criteria

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.