Testing Decision Aids to Improve Prostate Cancer Decisions for Minority Men
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Stage II Prostate Cancer
- Sponsor
- Alliance for Clinical Trials in Oncology
- Enrollment
- 158
- Locations
- 28
- Primary Endpoint
- Knowledge Assessed by Prostate Cancer Treatment Questionnaire
- Status
- Completed
- Last Updated
- last year
Overview
Brief 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.
Investigators
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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Knowledge Assessed by Prostate Cancer Treatment Questionnaire
Time Frame: 12 months
The primary outcome, knowledge, will be assessed by a standardized questionnaire (i.e., Prostate Cancer Treatment Questionnaire) administered once, immediately after the clinical consultation while the patient is still at the study site. The number correct from this 12-item measure will be reduced to a percentage of total number correct. With 100%(12 out of 12 item average) being the best possible outcome and 0%(0 out of 12 item average) the worst possible outcome
Secondary Outcomes
- Decisional Quality as Measured by Decisional Conflict Scale Decisional Regret(12 months)
- Utilization as Determined by Chart Review(12 months)
- Clinical Time Required(12 months)
- Quality of Life Assessed by Questionnaire(12 months)