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


N/A
21 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To investigate the feasibility

Outcome Description:

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

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Christian Nelson, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

10-204

NCT ID:

NCT01275404

Start Date:

December 2010

Completion Date:

December 2014

Related Keywords:

  • Prostate Cancer
  • Erectile Dysfunction
  • focus group
  • Quality of Life
  • 10-204
  • Prostatic Neoplasms
  • Erectile Dysfunction

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021