This trial is active, not recruiting.

Condition prostate cancer
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

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(No Intervention)
prostate cancer treatment desi Decision Support Intervention
DESI is a 50 minute program on treatment choices for prostate cancer that will be given out to the experimental group. The program explains several treatment options including surgery (radical prostatectomy), radiation therapy (external beam and/or brachytherapy), hormone therapy, and active surveillance and watchful waiting. The program's intended audience is men with early state prostate cancer who are trying to make a treatment decision.

Primary Outcomes

Comparison of Active treatment vs. Watchful waiting/active surveillance at 3 and 6 months
time frame: 3 and 6 month follow-up

Secondary Outcomes

DESI viewing
time frame: 3 month follow-up (phone survey)
Healthcare utilization
time frame: 6 month follow-up

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2013.
Information provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill.