Decision Support Interventions (DESI) for Prostate Cancer Screening and Treatment - Study 2
This trial is active, not recruiting.
|Treatment||prostate cancer treatment desi|
|Sponsor||University of North Carolina, Chapel Hill|
|Collaborator||Palo Alto Medical Foundation|
|Start date||December 2010|
|End date||July 2013|
|Trial size||218 participants|
|Trial identifier||NCT01244568, 10-1318, 1R18AE000023 - 01|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
Comparison of Active treatment vs. Watchful waiting/active surveillance at 3 and 6 months
time frame: 3 and 6 month follow-up
time frame: 3 month follow-up (phone survey)
time frame: 6 month follow-up
Male participants at least 45 years old.
Inclusion Criteria: Age 45 or older Localized prostate cancer with a Gleason score of 6 or less Exclusion Criteria: Women
|Official title||Acceleration Adoption of Comparative Effectiveness Research Results With Patient Decision Support Intervention and Treatment- Study 2|
|Principal investigator||Carmen L Lewis, MD, MPH|
|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.|
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