Early Staged Consent Before Prostate Biopsy

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Behavioral: Meditation; Procedure: Prostate Biopsy; Behavioral: Questionnaires

• Registration Number: NCT03507725
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-11
• Study First Submitted: 2018-04-15
• Study First Submitted QC: 2018-04-15
• Study First Posted: 2018-04-25
• Status Verified: 2024-10
• Primary Completion: 2024-10-14
• Study Completion: 2024-10-14
• Last Update Submitted: 2024-10-15
• Last Update Posted: 2024-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 390

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care + Meditation	Questionnaires	Usual care (local anaesthesia) + audio-recorded brief mind-dody intervention for 10 minutes before and for 10 minutes during the prostate biopsy procedure
Usual Care + Meditation	Prostate Biopsy	Usual care (local anaesthesia) + audio-recorded brief mind-dody intervention for 10 minutes before and for 10 minutes during the prostate biopsy procedure
Usual Care Group	Questionnaires	Time-and-attention control group receiving usual care (local anesthesia) including optional background music in the biopsy procedure room
Usual Care + Meditation	Meditation	Usual care (local anaesthesia) + audio-recorded brief mind-dody intervention for 10 minutes before and for 10 minutes during the prostate biopsy procedure
Usual Care Group	Prostate Biopsy	Time-and-attention control group receiving usual care (local anesthesia) including optional background music in the biopsy procedure room

Primary Outcome Measures

Name	Time	Method
number of patients who sign consent form	2 years

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States