Helping Men Adhere to Sexual Rehabilitation Following Prostate Cancer Surgery

Part of paid clinical trials in New York, New York.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT02706561
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • questionnaires — BEHAVIORAL
  • three in-person sessions — BEHAVIORAL
  • monthly phone calls — BEHAVIORAL
  • Acceptance and Commitment Therapy for Erectile Dysfunction (ACT-ED) — BEHAVIORAL
  • Enhanced Monitoring and Education (EME) — BEHAVIORAL

Study Details

The purpose of this study is to test two different ways to help men with sexual rehabilitation.

Key Dates

Start date
Dec 8, 2015
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
224 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Standard care plus the ACT intervention (ACT-ED)
    SC + ACT-ED-Group A uses Acceptance and Commitment Therapy (ACT). In this group, men focus on: long-term goals of rehabilitation; acceptance of the frustration related to ED; identifying and overcoming barriers; and committing to an erectile rehabilitation program. All participants will be asked to complete a set of questionnaires (baseline). The participants can complete it using your personal computer, one of MSKCC computers, in-person or over the phone. The questionnaires will take about 45-60 minutes to complete. You will also complete the same set of questionnaires at 6, 12, 18, and 24 months following study entry. In both groups, the participant will receive three in-person sessions or phone (30-45 minutes), six brief telephone sessions (5-10 minutes), and six monthly phone calls (5-10 minutes)
  • Experimental: SC plus nurse Enhanced Monitoring and Education (EME)
    SC + EME-Group B uses enhanced monitoring and education. This group focuses on answering questions about the rehabilitation program, manage technical issues related to injections, and the dose titration of injection medication. Participants in this group will also receive education on the side effects and impact of prostate cancer surgery, and strategies for restarting sexual activity. All participants will be asked to complete a set of questionnaires (baseline). You can complete it using your personal computer, one of MSKCC computers, in-person or over the phone. The questionnaires will take about 45-60 minutes to complete. The participant will also complete the same set of questionnaires at 6, 12, 18, and 24 months following study entry. In both groups, the participant will receive three in-person sessions or phone (30-45 minutes), six brief telephone sessions (5-10 minutes), and six monthly phone calls (5-10 minutes).

Primary Outcome Measure

percentages of patients having an Erectile Function Domain (EFD) total score >= 24 [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Rebecca Saracino, PhD
646-888-0263

Find similar trials in New York, NY

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Memorial Sloan Kettering Cancer Center· New York, NY

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