Early Staged Consent Before Prostate Biopsy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

390 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-11

Study Completion Date

2024-10-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Meditation

Intervention Type BEHAVIORAL

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).

Prostate Biopsy

Intervention Type PROCEDURE

Prostate needle biopsy under local anesthesia

Questionnaires

Intervention Type BEHAVIORAL

Questionnaires completion will be by telephone interview or manual completion of paper or online REDCap instruments, depending on participant preference.

Usual Care Group

Time-and-attention control group receiving usual care (local anesthesia) including optional background music in the biopsy procedure room

Group Type ACTIVE_COMPARATOR

Prostate Biopsy

Intervention Type PROCEDURE

Prostate needle biopsy under local anesthesia

Questionnaires

Intervention Type BEHAVIORAL

Questionnaires completion will be by telephone interview or manual completion of paper or online REDCap instruments, depending on participant preference.

Interventions

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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).

Intervention Type BEHAVIORAL

Prostate Biopsy

Prostate needle biopsy under local anesthesia

Intervention Type PROCEDURE

Questionnaires

Questionnaires completion will be by telephone interview or manual completion of paper or online REDCap instruments, depending on participant preference.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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