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

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.

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