Early Staged Consent Before Prostate Biopsy
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
390 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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