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

Alliance for Clinical Trials in Oncology

Status and phase: Completed; Phase 3

Conditions: PSA Level Less Than Five; Stage II Prostate Cancer; Stage I Prostate Cancer; Stage IIA Prostate Cancer; PSA Level Five to Ten; Stage III Prostate Cancer; PSA Level Ten to Fifty; Stage IIB Prostate Cancer

Treatments: Other: Laboratory Biomarker Analysis; Other: Best Practice; Other: Questionnaire Administration; Other: Quality-of-Life Assessment; Other: Survey Administration; Other: Internet-Based Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03103321

NCI-2017-00482 (Registry Identifier)

A191402CD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 158 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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158 participants in 4 patient groups

Arm A ("Knowing your Options", "Prostate Choice")

Experimental group

Description:

Patients receive decision aids "Knowing your Options" before and "Prostate Choice" during their consultation visit.

Treatment:

Other: Internet-Based Intervention

Other: Survey Administration

Other: Quality-of-Life Assessment

Other: Questionnaire Administration

Other: Laboratory Biomarker Analysis

Other: Internet-Based Intervention

Arm B ("Knowing your Options")

Experimental group

Description:

Patients receive "Knowing your Options" decision aid before their consultation visit.

Treatment:

Other: Internet-Based Intervention

Other: Survey Administration

Other: Quality-of-Life Assessment

Other: Questionnaire Administration

Other: Laboratory Biomarker Analysis

Other: Internet-Based Intervention

Arm C ("Prostate Choice")

Experimental group

Description:

Patients receive "Prostate Choice" decision aid during their consultation visit.

Treatment:

Other: Internet-Based Intervention

Other: Survey Administration

Other: Quality-of-Life Assessment

Other: Questionnaire Administration

Other: Laboratory Biomarker Analysis

Other: Internet-Based Intervention

Arm D (usual care)

Active Comparator group

Description:

Patients undergo usual care.

Treatment:

Other: Survey Administration

Other: Quality-of-Life Assessment

Other: Questionnaire Administration

Other: Best Practice

Other: Laboratory Biomarker Analysis