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ACT-ED + EME for Prostate Cancer and Erectile Dysfunction

N/A

Recruiting

Led By Chris Nelson, PhD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

As per medical record, early stage prostate cancer (Pathologic Stage 1/2 with Gleason score </=8; or Pathologic Stage 3 with Gleason score =/< 7)

As per medical record, radical prostatectomy (RP) conducted either at MSKCC or at another institution

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial is testing two different methods to help men with sexual rehabilitation.

Who is the study for?

This trial is for men who've had prostate surgery within the last 9 months and are starting penile injections as part of their sexual rehabilitation. They should have had moderate erectile function before surgery and early stage prostate cancer. Men with both nerves fully resected, on hormone therapy, or with untreated major psychiatric disorders cannot join.Check my eligibility

What is being tested?

The study tests two methods to aid sexual rehabilitation after prostate cancer surgery: Acceptance and Commitment Therapy (ACT-ED) involving three in-person sessions plus monthly calls, versus Enhanced Monitoring and Education (EME). Participants will also complete questionnaires.See study design

What are the potential side effects?

Since this trial involves therapy sessions and education rather than medication, typical drug side effects aren't expected. However, participants may experience emotional discomfort or stress during psychological interventions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate cancer is in an early stage with a low to moderate Gleason score.

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I have had a radical prostatectomy.

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I had my prostate removed less than 9 months ago.

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I had moderate erectile function before surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

percentages of patients having an Erectile Function Domain (EFD) total score >= 24

Trial Design

2Treatment groups

Experimental Treatment

Group I: Standard care plus the ACT intervention (ACT-ED)Experimental Treatment4 Interventions

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)

Group II: SC plus nurse Enhanced Monitoring and Education (EME)Experimental Treatment4 Interventions

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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

questionnaires

2008

Completed Phase 2

~3450

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,934 Previous Clinical Trials

588,586 Total Patients Enrolled

132 Trials studying Prostate Cancer

51,850 Patients Enrolled for Prostate Cancer

Center for Marital and Sexual Health of South FloridaOTHER

1 Previous Clinical Trials

99 Total Patients Enrolled

1 Trials studying Prostate Cancer

99 Patients Enrolled for Prostate Cancer

Chris Nelson, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Media Library

three in-person sessions Clinical Trial Eligibility Overview. Trial Name: NCT02706561 — N/A

Prostate Cancer Research Study Groups: SC plus nurse Enhanced Monitoring and Education (EME), Standard care plus the ACT intervention (ACT-ED)

Prostate Cancer Clinical Trial 2023: three in-person sessions Highlights & Side Effects. Trial Name: NCT02706561 — N/A

three in-person sessions 2023 Treatment Timeline for Medical Study. Trial Name: NCT02706561 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the aggregate of participants involved in this medical experiment?

"Affirmative. The clinicaltrials.gov site indicates that this research project is still seeking eligible individuals who meet the criteria of participation. It was originally posted on December 8th 2015 and modified most recently on May 11th 2022, with 224 patients being screened at 1 centre thus far."

Answered by AI

Are the researchers actively looking for new participants in this experiment?

"As per the details posted on clinicaltrials.gov, this research project is still searching for participants. Initially made available to the public on December 8th 2015 and most recently amended on May 11th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Helping Men Adhere to Sexual Rehabilitation Following Prostate Cancer Surgery

2015. "Helping Men Adhere to Sexual Rehabilitation Following Prostate Cancer Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02706561.

All > Prostate Cancer New York > Erectile Dysfunction