Early Staged Consent Before Prostate Biopsy

October 15, 2024 updated by: Memorial Sloan Kettering Cancer Center

Improving Patient Experience and Outcomes for Men Undergoing Prostate Biopsy: A Randomized Controlled Trial With Early Stage Consent

This is a study and a novel approach to clinical trials, testing the feasibility and acceptability of two-stage consent in the context of a trial integrated into routine clinical practice. The investigator will use, as a model, a trial of a brief mind-body intervention) with guided imagery for procedural pain at the time of prostate biopsy. In the two-stage design, patients will first be approached for consent to 1) have their routinely collected clinical data used for research purposes and 2) be randomly selected to be offered an intervention to improve the experience of prostate biopsy. Only patients randomized to the experimental arm will be informed about the benefits and harms of the intervention and will sign a second consent for the experimental treatment. There will be two separate randomizations in this study, one-stage (usual informed consent) vs. two-stage consent and mindfulness intervention vs. control.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

390

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • All male patients that will be scheduled for standard prostate needle biopsy (first, repeat or active surveillance biopsy) under local anesthesia and potentially consented to the mindfulness study of mind-body intervention for prostate biopsy within the next 12 months.
  • English fluent

Exclusion Criteria:

  • Patient with prior rectal surgery or anal stricture requiring surgical intervention prior to biopsy.
  • Prior prostate radiation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Usual Care + Meditation
Usual care (local anaesthesia) + audio-recorded brief mind-dody intervention for 10 minutes before and for 10 minutes during the prostate biopsy procedure
Behavioral: Meditation
The brief mind-body intervention, specifically developed for this study, is a combination of "mindfulness meditation" with a specific cognitive component of "guided imagery". Patient intervention, they will be given headphones connected to an MP4 player in the clinic area to listen to a pre-biopsy mindfulness exercise (10 minutes). They will then be brought into the biopsy procedure room and given a second set of headphones, guiding the patient through the mindfulness intervention during the biopsy procedure (10 minutes).
Procedure: Prostate Biopsy
Prostate needle biopsy under local anesthesia
Behavioral: Questionnaires
Questionnaires completion will be by telephone interview or manual completion of paper or online REDCap instruments, depending on participant preference.
Active Comparator: Usual Care Group
Time-and-attention control group receiving usual care (local anesthesia) including optional background music in the biopsy procedure room
Procedure: Prostate Biopsy
Prostate needle biopsy under local anesthesia
Behavioral: Questionnaires
Questionnaires completion will be by telephone interview or manual completion of paper or online REDCap instruments, depending on participant preference.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of patients who sign consent form
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Behrar Ehdaie, MD, MPH, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 11, 2018

Primary Completion (Actual)

October 14, 2024

Study Completion (Actual)

October 14, 2024

Study Registration Dates

First Submitted

April 15, 2018

First Submitted That Met QC Criteria

April 15, 2018

First Posted (Actual)

April 25, 2018

Study Record Updates

Last Update Posted (Actual)

October 16, 2024

Last Update Submitted That Met QC Criteria

October 15, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-189

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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