Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Male
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Health Services Research
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A ("Knowing your Options", "Prostate Choice")
Patients receive decision aids "Knowing your Options" before and "Prostate Choice" during their consultation visit.
  • Other: Internet-Based Intervention
    Receive "Knowing your Options" decision aid
  • Other: Internet-Based Intervention
    Receive "Prostate Choice" decision aid
  • Other: Quality-of-Life Assessment
    Ancillary studies
  • Other: Questionnaire Administration
    Ancillary studies
  • Other: Survey Administration
    Ancillary studies
  • Other: Laboratory Biomarker Analysis
    Correlative studies
Experimental
Arm B ("Knowing your Options")
Patients receive "Knowing your Options" decision aid before their consultation visit.
  • Other: Internet-Based Intervention
    Receive "Knowing your Options" decision aid
  • Other: Quality-of-Life Assessment
    Ancillary studies
  • Other: Questionnaire Administration
    Ancillary studies
  • Other: Survey Administration
    Ancillary studies
  • Other: Laboratory Biomarker Analysis
    Correlative studies
Experimental
Arm C ("Prostate Choice")
Patients receive "Prostate Choice" decision aid during their consultation visit.
  • Other: Internet-Based Intervention
    Receive "Prostate Choice" decision aid
  • Other: Quality-of-Life Assessment
    Ancillary studies
  • Other: Questionnaire Administration
    Ancillary studies
  • Other: Survey Administration
    Ancillary studies
  • Other: Laboratory Biomarker Analysis
    Correlative studies
Active Comparator
Arm D (usual care)
Patients undergo usual care.
  • Other: Best Practice
    Undergo usual care
    Other names:
    • standard of care
    • standard therapy
  • Other: Quality-of-Life Assessment
    Ancillary studies
  • Other: Questionnaire Administration
    Ancillary studies
  • Other: Survey Administration
    Ancillary studies
  • Other: Laboratory Biomarker Analysis
    Correlative studies

Recruiting Locations

Montefiore Medical Center-Einstein Campus
Bronx, New York 10461
Contact:
Site Public Contact
718-379-6866
aaraiza@montefiore.org

More Details

NCT ID
NCT03103321
Status
Recruiting
Sponsor
Alliance for Clinical Trials in Oncology

Study Contact

Jon Tilburt, MD
855-776-0015
tilburt.jon@mayo.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.