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

NCT01275404 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2019-07-15

No results posted yet for this study

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.

Conditions

Interventions

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).

Sponsors & Collaborators

Principal Investigators

  • Christian Nelson, PhD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-28
Primary Completion
2019-07-10
Completion
2019-07-10

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01275404 on ClinicalTrials.gov