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Completed

NCT Number: NCT01275404

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.

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Key information

Conditions

Prostate Cancer Erectile Dysfunction Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Mental Disorders Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases Urogenital Neoplasms

Age range

21 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sexual Medicine Rehabilitation Program + nurse practitioner information phone calls

Behavioral

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

Behavioral

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

  1. To investigate the feasibility

    Time frame: 2 years

    acceptability, tolerability and adherence) of adapted ACT psychotherapy treatment integrated into an erectile rehabilitation program (i.e., ACT-ED).

Secondary outcomes

  1. To investigate the impact of ACT-ED

    Time frame: 2 years

    on penile injection compliance, ED treatment satisfaction, sexual functioning, sexual self-esteem, ED bother, depression symptoms, acceptance and self-awareness.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • Center for Marital and Sexual Health of South Florida
  • National Institutes of Health (NIH)

Registry information

Official study title

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

Acronym: ACT-ED

Important dates

Study start
2010
Primary completion
2019
Study completion
2019
First posted
Jan 12, 2011
Registry last updated
Jul 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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