Decision Aids in Improving Knowledge in Patients With Newly Diagnosed Prostate Cancer

Completed · Phase 3

Conditions studied: Stage II Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer, Stage III Prostate Cancer, Stage I Prostate Cancer, PSA Level Five to Ten, PSA Level Less Than Five, PSA Level Ten to Fifty

In brief

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.

Key facts

Study ID

NCT03103321

Run by

Alliance for Clinical Trials in Oncology

People needed

158

Starts

2017-10-02

Expected to finish

2020-11-25

Last updated by the study team

2025-01-27

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have prostate biopsy within 4 months prior to registration showing newly diagnosed prostate cancer, stage T1-3N0M0; in addition, patients must have: Gleason score 6-10
• Prostate-specific antigen (PSA) < 50 ng/mL
• Patients who have had a history of non-cutaneous malignancy in the previous 5 years are not eligible; exception: patients with history of non-melanoma skin cancer are eligible
• Scheduled prostate cancer consultation to be the first consultation after diagnosis (i.e. not a second-opinion or a consultation following previous discussions of treatment options)
• Patients may not be concurrently enrolled to another clinical trial for the treatment of cancer; co-enrollment to biospecimen studies is allowed
• Patients with impaired decision-making capacity (such as with a diagnosis of dementia or memory loss) are not eligible for this study
• Patients must be able to read and comprehend English; non-English-speaking patients may participate so long as an interpreter (e.g., family member, clinic staff, etc.) is present for consent, for the decision aid administration, and gathering of baseline and follow-up measures

Where it is running

• 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
• 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
• Montefiore Medical Center-Einstein Campus — The Bronx, New York, United States
• Montefiore Medical Center-Weiler Hospital — The Bronx, New York, United States
• Montefiore Medical Center - Moses Campus — The Bronx, New York, United States
• James J Peters VA Medical Center — The Bronx, 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

Full record on ClinicalTrials.gov

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