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Early Staged Consent Before Prostate Biopsy

Not Applicable
Completed
Conditions
Prostate Cancer
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

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
Primary Outcome Measures
NameTimeMethod
number of patients who sign consent form2 years
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center

🇺🇸

New York, New York, United States

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

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