Decision Aids in Improving Knowledge in Patients With Newly Diagnosed Prostate Cancer
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.
- 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
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Accepts Healthy Volunteers
- 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
- 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
- Scheduled prostate cancer consultation to be the first consultation after diagnosis
(i.e. not a second-opinion or a consultation following previous discussions of
- 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
- Phase 3
- Study Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Health Services Research
- None (Open Label)
Arm A ("Knowing your Options", "Prostate Choice")
|Patients receive decision aids "Knowing your Options" before and "Prostate Choice" during their consultation visit.||
Arm B ("Knowing your Options")
|Patients receive "Knowing your Options" decision aid before their consultation visit.||
Arm C ("Prostate Choice")
|Patients receive "Prostate Choice" decision aid during their consultation visit.||
Arm D (usual care)
|Patients undergo usual care.||
- NCT ID
- Alliance for Clinical Trials in Oncology
Study ContactJon Tilburt, MD
I. To test the comparative effectiveness of decision aids (DA's) on patient knowledge.
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.