This trial studies how well a brief mind-body intervention works for the improvement of patient experience and outcomes in men who are undergoing prostate biopsy. The brief mind-body intervention involves mindfulness meditation which focuses on using positive images and breathing exercises that may lower the levels of pain, discomfort, and anxiety in patients prior to undergoing prostate biopsies.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03507725.
PRIMARY OBJECTIVE:
I. Determine the feasibility of staged consent in terms of accrual, patient understanding, and patient distress compared to standard one-stage consent.
SECONDARY OBJECTIVE:
I. Evaluate the effectiveness of a brief mind-body intervention on pain, anxiety, discomfort, and intolerability during prostate biopsy.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (MINDFULNESS MEDITATION): Patients receive a brief mind-body intervention consisting of audio-guided mindfulness meditation exercises over 10 minutes before and during prostate needle biopsy. Patients also have the option of listening to background music during the procedure.
ARM II (USUAL CARE): Patients undergo needle biopsy of the prostate per usual care and also have the option of listening to background music during the procedure.
After completion of study intervention, patients are followed up at 30 days.
Trial PhaseNo phase specified
Trial Typehealth services research
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorBehfar Ehdaie
