Early Staged Consent Before Prostate Biopsy

Study Overview
=================
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.

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

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Behavioral: Meditation
* Procedure: Prostate Biopsy
* Behavioral: Questionnaires


Participation Criteria
=================
Eligibility Criteria
-----------------
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
Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Usual Care + Meditation<br>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<br>* 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).<br>Procedure: Prostate Biopsy<br>* Prostate needle biopsy under local anesthesia<br>Behavioral: Questionnaires<br>* Questionnaires completion will be by telephone interview or manual completion of paper or online REDCap instruments, depending on participant preference.<br>|
| Active Comparator: Usual Care Group<br>Time-and-attention control group receiving usual care (local anesthesia) including optional background music in the biopsy procedure room | Procedure: Prostate Biopsy<br>* Prostate needle biopsy under local anesthesia<br>Behavioral: Questionnaires<br>* Questionnaires completion will be by telephone interview or manual completion of paper or online REDCap instruments, depending on participant preference.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients who sign consent form |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mind-body intervention, 18-189