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Decision Aids in Improving Knowledge in Patients With Newly Diagnosed Prostate Cancer
New York, NY
Phase 3
Waitlist Available
Research Sponsored by Alliance for Clinical Trials in Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial
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.
See full description
Eligible Conditions
- Prostate Cancer
- Low PSA Level
- Prostate-Specific Antigen
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Knowledge Assessed by Prostate Cancer Treatment Questionnaire
Secondary study objectives
Clinical Time Required
Decisional Quality as Measured by Decisional Conflict Scale Decisional Regret
Quality of Life Assessed by Questionnaire
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Arm C ("Prostate Choice")Experimental Treatment5 Interventions
Patients receive "Prostate Choice" decision aid during their consultation visit.
Group II: Arm B ("Knowing your Options")Experimental Treatment5 Interventions
Patients receive "Knowing your Options" decision aid before their consultation visit.
Group III: Arm A ("Knowing your Options", "Prostate Choice")Experimental Treatment5 Interventions
Patients receive decision aids "Knowing your Options" before and "Prostate Choice" during their consultation visit.
Group IV: Arm D (usual care)Active Control5 Interventions
Patients undergo usual care.
Find a Location
Closest Location:NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center· New York, NY
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
14,031 Previous Clinical Trials
41,155,626 Total Patients Enrolled
Alliance for Clinical Trials in OncologyLead Sponsor
519 Previous Clinical Trials
222,126 Total Patients Enrolled
tilburt.jon@mayo.edu tilburt.jon@mayo.edu, MDStudy ChairMayo Clinic