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Spots Global Cancer Trial Database for Decision Aids in Improving Knowledge in Patients With Newly Diagnosed Prostate Cancer

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Trial Identification

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

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

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

Contact Details

Name: tilburt.jon@mayo.edu tilburt.jon@mayo.edu, MD

Affiliation: Mayo Clinic

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

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