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

Primary Purpose

Prostate Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Sexual Medicine Rehabilitation Program + nurse practitioner information phone calls

Sexual Medicine Rehabilitation Program + Acceptance and Commitment Therapy for Erectile Dysfunction

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Erectile Dysfunction, focus group, Quality of Life, 10-204

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

(SMRP) + nurse practitioner information phone calls

SMRP+ACT-ED

Arm Description

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).

Outcomes

Primary Outcome Measures

To investigate the feasibility

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01275404

First Posted

January 11, 2011

Last Updated

July 11, 2019

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT01275404

Brief Title

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

Acronym

ACT-ED

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

December 28, 2010 (Actual)

Primary Completion Date

July 10, 2019 (Actual)

Study Completion Date

July 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

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

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

Erectile Dysfunction, focus group, Quality of Life, 10-204

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

99 (Actual)

8. Arms, Groups, and Interventions

Arm Title

(SMRP) + nurse practitioner information phone calls

Arm Type

Experimental

Arm Description

Arm Title

SMRP+ACT-ED

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Sexual Medicine Rehabilitation Program + nurse practitioner information phone calls

Intervention Description

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).

Intervention Type

Behavioral

Intervention Name(s)

Sexual Medicine Rehabilitation Program + Acceptance and Commitment Therapy for Erectile Dysfunction

Intervention Description

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 Outcome Measure Information:

Title

To investigate the feasibility

Description

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

Time Frame

2 years

Secondary Outcome Measure Information:

Title

To investigate the impact of ACT-ED

Description

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

Time Frame

2 years

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christian Nelson, PhD

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Memorial Sloan Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.mskcc.org/mskcc/html/44.cfm

Description

Memorial Sloan-Kettering Cancer Center

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

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