Spots Global Cancer Trial Database for Early Staged Consent Before Prostate Biopsy
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Trial Identification
Brief Title: Early Staged Consent Before Prostate Biopsy
Official Title: Improving Patient Experience and Outcomes for Men Undergoing Prostate Biopsy: A Randomized Controlled Trial With Early Stage Consent
Study ID: NCT03507725
Conditions
Study Description
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:
Keywords
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Contact Details
Name: Behrar Ehdaie, MD, MPH
Affiliation: Memorial Sloan Kettering Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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