Clinical trial NCT01244568: Decision Support Interventions (DESI) for Prostate Cancer Screening and Treatment - Study 2
Official title: Acceleration Adoption of Comparative Effectiveness Research Results With Patient Decision Support Intervention and Treatment- Study 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Decision support interventions (DESI)
Comparative Effectiveness Research (CER)
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Palo Alto Medical Foundation
name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2010-11-19
Enrollment: 218
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

Age 45 or older Localized prostate cancer with a Gleason score of 6 or less

Exclusion Criteria:

Women

Primary outcomes:
measure: Comparison of Active treatment vs. Watchful waiting/active surveillance at 3 and 6 months
timeFrame: 3 and 6 month follow-up
Secondary outcomes:
measure: DESI viewing
timeFrame: 3 month follow-up (phone survey)
measure: Healthcare utilization
timeFrame: 6 month follow-up
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Palo Alto Medical Foundation Research Institute
state: California
city: Chapel Hill
country: United States
facility: University of North Carolina, Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Carmen L Lewis, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Palo Alto Medical Foundation
name: Ming Tai-Seale, Ph.D, MPH
role: PRINCIPAL_INVESTIGATOR
References: