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.
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
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
Name | Type | Description | Interventions |
---|
Arm A (Knowing Your Options) | Experimental | Arm A ("Knowing your Options") Patients receive "Knowing your Options" decision aid before their consultation visit. | |
Arm B (Prostate Choice) | Experimental | Patients receive "Prostate Choice" decision aid during their consultation visit. | |
Arm C (Usual Care) | Active Comparator | Patients 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
December 3, 2020