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Brief Title: Decision Aids in Improving Knowledge in Patients With Newly Diagnosed Prostate Cancer
Official Title: Testing Decision Aids to Improve Prostate Cancer Decisions for Minority Men
Study ID: NCT03103321
Brief Summary: This randomized phase III trial studies how well decision aids work in improving knowledge in patients with newly diagnosed prostate cancer. Decision aids may improve patients' knowledge of their condition and options for treatment, and may also help when talking with their doctor.
Detailed Description: PRIMARY OBJECTIVES: I. To test the comparative effectiveness of decision aids (DA's) on patient knowledge. SECONDARY OBJECTIVES: I. To test the impact of in-visit DA's alone compared to usual care on quality of life outcomes and treatment utilization. II. To test the impact of out-of-visit DA's alone compared to usual care on quality of life outcomes and treatment utilization. III. To test the impact of combined in-visit and out-of-visit DA's compared to both usual care and individual DAs on quality of life outcomes and treatment utilization. IV. To test the comparative effectiveness of DA's on minority men's knowledge. V. To compare clinic time required to administer the DA's across arms. OUTLINE: Patients are randomized into 1 of 4 arms. ARM A: Patients receive decision aids "Knowing your Options" before and "Prostate Choice" during their consultation visit. ARM B: Patients receive "Knowing your Options" decision aid before their consultation visit. ARM C: Patients receive "Prostate Choice" decision aid during their consultation visit. ARM D: Patients undergo usual care. After completion of study, patients are followed up at 12 months.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Kaiser Permanente-Bellflower, Bellflower, California, United States
Kaiser Permanente-Cadillac, Los Angeles, California, United States
Kaiser Permanente Oakland-Broadway, Oakland, California, United States
Augusta University Medical Center, Augusta, Georgia, United States
Tripler Army Medical Center, Honolulu, Hawaii, United States
John H Stroger Jr Hospital of Cook County, Chicago, Illinois, United States
Ochsner Health Center-Summa, Baton Rouge, Louisiana, United States
Ochsner Medical Center Jefferson, New Orleans, Louisiana, United States
Louisiana State University Health Sciences Center Shreveport, Shreveport, Louisiana, United States
William Beaumont Hospital-Royal Oak, Royal Oak, Michigan, United States
University of New Mexico Cancer Center, Albuquerque, New Mexico, United States
Montefiore Medical Center-Einstein Campus, Bronx, New York, United States
Montefiore Medical Center-Weiler Hospital, Bronx, New York, United States
Montefiore Medical Center - Moses Campus, Bronx, New York, United States
James J Peters VA Medical Center, Bronx, New York, United States
Northwell Health/Center for Advanced Medicine, Lake Success, New York, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center, New York, New York, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Prisma Health Cancer Institute - Laurens, Clinton, South Carolina, United States
Prisma Health Cancer Institute - Easley, Easley, South Carolina, United States
Prisma Health Cancer Institute - Butternut, Greenville, South Carolina, United States
Prisma Health Cancer Institute - Faris, Greenville, South Carolina, United States
Prisma Health Greenville Memorial Hospital, Greenville, South Carolina, United States
Prisma Health Cancer Institute - Eastside, Greenville, South Carolina, United States
Prisma Health Cancer Institute - Greer, Greer, South Carolina, United States
Prisma Health Cancer Institute - Seneca, Seneca, South Carolina, United States
Prisma Health Cancer Institute - Spartanburg, Spartanburg, South Carolina, United States
Virginia Commonwealth University/Massey Cancer Center, Richmond, Virginia, United States
Name: tilburt.jon@mayo.edu tilburt.jon@mayo.edu, MD
Affiliation: Mayo Clinic
Role: STUDY_CHAIR