Clinical Trials /

Decision Aids to Improve Knowledge in Patients With Prostate Cancer

NCT03182998

Description:

This randomized phase III trial studies how well decision aids work in improving knowledge in patients with prostate cancer. Decision aids may improve patients' knowledge of their condition and options for treatment, and may also help when talking with their doctor.

Related Conditions:
  • Prostate Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: Decision Aids to Improve Knowledge in Patients With Prostate Cancer
  • Official Title: Testing Decision Aids to Improve Prostate Cancer Decisions for Minority Men

Clinical Trial IDs

  • ORG STUDY ID: 16-010459
  • SECONDARY ID: R01MD008934-05
  • NCT ID: NCT03182998

Conditions

  • Prostate Cancer

Purpose

This randomized phase III trial studies how well decision aids work in improving knowledge in patients with prostate cancer. Decision aids may improve patients' knowledge of their condition and options for treatment, and may also help when talking with their doctor.

Trial Arms

NameTypeDescriptionInterventions
Arm A (Knowing Your Options)ExperimentalArm A ("Knowing your Options") Patients receive "Knowing your Options" decision aid before their consultation visit.
    Arm B (Prostate Choice)ExperimentalPatients receive "Prostate Choice" decision aid during their consultation visit.
      Arm C (Usual Care)Active ComparatorPatients undergo usual care.

        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
              
        Maximum Eligible Age:N/A
        Minimum Eligible Age:18 Years
        Eligible Gender:Male
        Healthy Volunteers:No

        Primary Outcome Measures

        Measure:Knowledge assessed by Prostate Cancer Treatment questionnaire
        Time Frame:Up to 12 months
        Safety Issue:
        Description:A mixed effects regression model (also known as random effects model or multi-level model) will be utilized to examine the effects of the during-consultation Prostate Choice and the pre-consultation Knowing Your Options decision aids. Specifically, this model will contain a fixed intercept, a fixed effect for having received Prostate Choice, a fixed effect for having received Knowing Your Options. Baseline patient-level characteristics including race, ethnicity, severity of disease and site-level characteristics may be incorporated in this model if deemed appropriate.

        Secondary Outcome Measures

        Measure:Decisional quality as measured by Decisional Conflict Scale Decisional Regret
        Time Frame:Up to 12 months
        Safety Issue:
        Description:Will be compared across DA types using linear mixed models. In particular, this model will include fixed effects for Prostate Choice and Knowing Your Options and a random, site-specific intercept to allow for subjects within the same site to be correlated. Will explore whether the overall effects of interventions on patient knowledge, quality of life, and treatment utilization differ by racial/ethnic subgroups.
        Measure:Quality of life assessed by questionnaire
        Time Frame:Up to 12 months
        Safety Issue:
        Description:Will be converted into continuous summary scores using standard algorithms. Will be compared across DA types using linear mixed models. In particular, this model will include fixed effects for Prostate Choice and Knowing Your Options and a random, site-specific intercept to allow for subjects within the same site to be correlated. Will explore whether the overall effects of interventions on patient knowledge, quality of life, and treatment utilization differ by racial/ethnic subgroups.
        Measure:Utilization as determined by chart review
        Time Frame:At 12 months
        Safety Issue:
        Description:Will be categorized by the type of treatment the patient received. Will be compared across DA types using linear mixed models. In particular, this model will include fixed effects for Prostate Choice and Knowing Your Options and a random, site-specific intercept to allow for subjects within the same site to be correlated. Will explore whether the overall effects of interventions on patient knowledge, quality of life, and treatment utilization differ by racial/ethnic subgroups.

        Details

        Phase:N/A
        Primary Purpose:Interventional
        Overall Status:Active, not recruiting
        Lead Sponsor:Mayo Clinic

        Last Updated

        October 2, 2019