Acceleration Adoption of Comparative Effectiveness Research Results With Patient Decision Support Intervention and Treatment- Study 2
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- University of North Carolina, Chapel Hill
- Enrollment
- 218
- Locations
- 2
- Primary Endpoint
- Comparison of Active treatment vs. Watchful waiting/active surveillance at 3 and 6 months
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
Researchers in this study will determine whether providing decision support interventions (DESIs) to men with low risk prostate cancer improves their decision-specific knowledge and alters their treatment decisions.
Detailed Description
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.
Investigators
Carmen Lewis, MD, MPH
Associate Professor
University of North Carolina, Chapel Hill
Eligibility Criteria
Inclusion Criteria
- •Age 45 or older Localized prostate cancer with a Gleason score of 6 or less
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Comparison of Active treatment vs. Watchful waiting/active surveillance at 3 and 6 months
Time Frame: 3 and 6 month follow-up
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.
Secondary Outcomes
- DESI viewing(3 month follow-up (phone survey))
- Healthcare utilization(6 month follow-up)