Prostate Cancer
Conditions
Keywords
mind-body intervention, 18-189
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.
Interventions
BEHAVIORALMeditation
The brief mind-body intervention, specifically developed for this study, is a combination of mindfulness meditation with a specific cognitive component of guided imagery. Patient intervention, they will be given headphones connected to an MP4 player in the clinic area to listen to a pre-biopsy mindfulness exercise (10 minutes). They will then be brought into the biopsy procedure room and given a second set of headphones, guiding the patient through the mindfulness intervention during the biopsy procedure (10 minutes).
PROCEDUREProstate Biopsy
Prostate needle biopsy under local anesthesia
BEHAVIORALQuestionnaires
Questionnaires completion will be by telephone interview or manual completion of paper or online REDCap instruments, depending on participant preference.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| number of patients who sign consent form | 2 years |
Countries
United States
Outcome results
None listed