Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Alliance for Clinical Trials in Oncology
With
National Cancer Institute (NCI)
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.
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible 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
You may not be if
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 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
Clareo Health | Decision Aids in Improving Knowledge in Patients With Newly Diagnosed Prostate Cancer
