NCT03103321

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

Testing Decision Aids to Improve Prostate Cancer Decisions for Minority Men

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 158 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• 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

Interventions

Type	Name	Description
OTHER	Internet-Based Intervention	Receive "Knowing your Options" decision aid
OTHER	Internet-Based Intervention	Receive "Prostate Choice" decision aid
OTHER	Best Practice	Undergo usual care
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies
OTHER	Survey Administration	Ancillary studies
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2017-10-02
• Primary completion: 2019-12-05
• Completion: 2020-11-25
• First posted: 2017-04-06
• Last updated: 2025-01-27
• Results posted: 2022-01-13

Locations

28 sites across 1 country: United States