Two-Stage Consent and Mindfulness for Prostate Cancer Screening
This trial is testing a new way of doing clinical trials, called two-stage consent. In this design, patients are first asked if they are okay with their routine clinical data being used for research. If they agree, they are then randomly selected to be offered an intervention that may improve their experience of a prostate biopsy. Only patients who are randomized to the experimental arm are informed about the benefits and risks of the intervention and are asked to sign a second consent form. There are two separate randomizations in this study: one-stage (usual informed consent) vs. two-stage consent and mindfulness intervention vs. control.