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

Prostate Cancer Clinical Trial

— ACT-ED  

Official title:

ACT-ED: Acceptance and Commitment Therapy for Erectile Dysfunction Adaptation of ACT for Compliance With an Erectile Rehabilitation Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01275404
• Other study ID #: 10-204
• Status: Completed
• Phase: N/A
• Start date: December 28, 2010
• Est. completion date: July 10, 2019

Study information

• Verified date: July 2019
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Erectile Dysfunction
• Prostate Cancer

Intervention

Behavioral:
• 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).
• 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).

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Center for Marital and Sexual Health of South Florida, National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   Memorial Sloan-Kettering Cancer Center