Acceleration Adoption of Comparative Effectiveness Research Results With Patient Decision Support Intervention and Treatment- Study 2
Potentially eligible men (age 45 and older who have localized prostate cancer with a Gleason
score of 6 or less) will be identified and recruited to participate in the study before
their next office visit. Patients who are interested and provide informed consent will be
asked to complete a brief survey about background, medical history, knowledge of prostate
cancer and health-related quality of life. Once the survey is completed the patient will be
randomly assigned to one of 2 groups. Those assigned to the "Usual Care" group will not
receive any additional information materials as part of their participation in the study.
Those assigned to the "Patient Decision Support" group will receive a DVD program that
contains information about treatment choices for prostate cancer.
Participants will be asked to answer a brief telephone survey at 3 and 6 months from the day
of their last office visit. Survey questions will ask about knowledge about prostate
cancer, health-related quality of life, whether or not the DVD was viewed and what treatment
decision was made.
Research staff will also review medical records 6 months after enrollment to determine which
treatment was received for prostate cancer, how many visits with health care providers were
completed since enrollment and which medical services and procedures were received.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Comparison of Active treatment vs. Watchful waiting/active surveillance at 3 and 6 months
Men who review a DESI before making a treatment decision will be more likely to choose active surveillance/watchful waiting and will have better decision-specific knowledge.
3 and 6 month follow-up
Carmen L Lewis, MD, MPH
University of North Carolina, Chapel Hill
United States: Institutional Review Board
|University of North Carolina, Chapel Hill||Chapel Hill, North Carolina 27599|
|Palo Alto Medical Foundation Research Institute||Palo Alto, California 94301|