Decision Aids in Improving Knowledge in Patients With Newly Diagnosed Prostate Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 172
Summary
- Conditions
- PSA Level Five to Ten
- PSA Level Less Than Five
- PSA Level Ten to Fifty
- Stage I Prostate Cancer
- Stage II Prostate Cancer
- Stage IIA Prostate Cancer
- Stage IIB Prostate Cancer
- Stage III Prostate Cancer
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Health Services Research
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
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 alon...
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.
Tracking Information
- NCT #
- NCT03103321
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Study Chair: tilburt.jon@mayo.edu tilburt.jon@mayo.edu, MD Mayo Clinic