Behavioral and Psychological Impact of Returning Breast Density Results to Latinas
Part of paid clinical trials in Phoenix, Arizona.
- Sponsor
- Mayo Clinic
- Study ID
- NCT02910986
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- FEMALE
- Age
- 40 Years - 74 Years
- Healthy Volunteers
- Accepted
Interventions
- Written educational brochure — BEHAVIORALWritten educational brochure about breast density
- Promotora interaction — BEHAVIORALPromotora education about breast density
Study Details
This study will examine behavioral and psychological outcomes of breast density notification using a 3-group randomized design comparing usual written notification to two educationally enhanced approaches.
Key Dates
- Start date
- Oct 27, 2016
- Status verified
- May 2025
- Primary completion
- Nov 15, 2019
- Completion
- Nov 15, 2019
Study Design
- Enrollment
- 1,386 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- HEALTH_SERVICES_RESEARCH
Arms
- No Intervention: Usual CareBreast density notification using standard language reporting for dense and non-dense breasts within the mammogram results notification letter
- Active Comparator: EnhancedUsual Care plus a written educational brochure
- Active Comparator: InterpersonalUsual Care plus Enhanced plus interaction with a promotora (lay health educator)
Primary Outcome Measure
Knowledge of Breast Density as a Masking Factor at First Follow-up [ Time Frame: Baseline (T0) to first follow-up (T1, 2 weeks to 180 days from education end) ]
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Mountain Park Health Center | Phoenix | Arizona | 85004 | - |
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | - |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | - |
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