Early Staged Consent Before Prostate Biopsy

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03507725
• Other study ID #: 18-189
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 11, 2018
• Est. completion date: April 2024

Study information

• Verified date: June 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 390
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patients who sign consent form		2 years

External Links

•   Memorial Sloan Kettering Cancer Center