Prostate Cancer Clinical Trial
Decision Aids in Improving Knowledge in Patients With Newly Diagnosed Prostate Cancer
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.
Full 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.
Eligibility Criteria
Inclusion Criteria:
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
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There are 25 Locations for this study
Bellflower California, 90706, United States
Los Angeles California, 90034, United States
Oakland California, 94611, United States
Augusta Georgia, 30912, United States
Honolulu Hawaii, 96859, United States
Chicago Illinois, 60612, United States
Baton Rouge Louisiana, 70809, United States
New Orleans Louisiana, 70121, United States
Shreveport Louisiana, 71103, United States
Royal Oak Michigan, 48073, United States
Albuquerque New Mexico, 87102, United States
Bronx New York, 10461, United States
Bronx New York, 10461, United States
Bronx New York, 10467, United States
Bronx New York, 10468, United States
Lake Success New York, 11042, United States
New York New York, 10032, United States
Charleston South Carolina, 29425, United States
Clinton South Carolina, 29325, United States
Easley South Carolina, 29640, United States
Greenville South Carolina, 29605, United States
Greenville South Carolina, 29605, United States
Greenville South Carolina, 29605, United States
Greenville South Carolina, 29615, United States
Greer South Carolina, 29650, United States
Seneca South Carolina, 29672, United States
Spartanburg South Carolina, 29307, United States
Richmond Virginia, 23298, United States
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