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 — BEHAVIORAL
    Written educational brochure about breast density
  • Promotora interaction — BEHAVIORAL
    Promotora 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 Care
    Breast density notification using standard language reporting for dense and non-dense breasts within the mammogram results notification letter
  • Active Comparator: Enhanced
    Usual Care plus a written educational brochure
  • Active Comparator: Interpersonal
    Usual 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)

FacilityCityStateZIPSite coordinators
Mountain Park Health CenterPhoenixArizona85004-
Mayo Clinic in ArizonaScottsdaleArizona85259-
Mayo Clinic in RochesterRochesterMinnesota55905-

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