Therapy for Erectile Dysfunction Adaptation of ACT for Compliance With an Erectile Rehabilitation Program (ACT-ED)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Center for Marital and Sexual Health of South Florida
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01275404
First received: January 11, 2011
Last updated: October 8, 2013
Last verified: October 2013

January 11, 2011
October 8, 2013
December 2010
December 2014   (final data collection date for primary outcome measure)
To investigate the feasibility [ Time Frame: 2 years ] [ Designated as safety issue: No ]
acceptability, tolerability and adherence) of adapted ACT psychotherapy treatment integrated into an erectile rehabilitation program (i.e., ACT-ED).
Same as current
Complete list of historical versions of study NCT01275404 on ClinicalTrials.gov Archive Site
To investigate the impact of ACT-ED [ Time Frame: 2 years ] [ Designated as safety issue: No ]
on penile injection compliance, ED treatment satisfaction, sexual functioning, sexual self-esteem, ED bother, depression symptoms, acceptance and self-awareness.
Same as current
Not Provided
Not Provided
 
Therapy for Erectile Dysfunction Adaptation of ACT for Compliance With an Erectile Rehabilitation Program
ACT-ED: Acceptance and Commitment Therapy for Erectile Dysfunction Adaptation of ACT for Compliance With an Erectile Rehabilitation Program

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
  • 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).
  • Behavioral: 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).
  • Experimental: (SMRP) + 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).
    Intervention: Behavioral: Sexual Medicine Rehabilitation Program + nurse practitioner information phone calls
  • Experimental: SMRP+ACT-ED
    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).
    Intervention: Behavioral: Sexual Medicine Rehabilitation Program + Acceptance and Commitment Therapy for Erectile Dysfunction
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
110
December 2014
December 2014   (final data collection date for primary outcome measure)

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.
Male
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01275404
10-204
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
  • National Institutes of Health (NIH)
  • Center for Marital and Sexual Health of South Florida
Principal Investigator: Christian Nelson, PhD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP