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Early Staged Consent Before Prostate Biopsy

NCT03507725 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 390

Last updated 2024-10-16

No results posted yet for this study

Summary

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.

Conditions

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Behrar Ehdaie, MD, MPH · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-11
Primary Completion
2024-10-14
Completion
2024-10-14

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT03507725 on ClinicalTrials.gov