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Completed

NCT Number: NCT02910986

Behavioral and Psychological Impact of Returning Breast Density Results to Latinas

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.

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Key information

Age range

40 year–74 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mountain Park Health Center, Phoenix, Arizona, United States

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About this study

This is a 3-group randomized clinical trial to compare usual care to two educationally enhanced approaches to breast density notification. Usual care involves sending written notification along with the mammogram report; all women will receive usual care. In addition, some women will receive written educational materials about breast density, with or without interaction with a promotora (culturally congruent health educator). Study outcomes include short and long term assessments of psychological (anxiety, knowledge) and behavioral (continued mammography screening, discussion with primary care provider) outcomes. The study also includes qualitative inquiry and a cost analysis.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female
  • Attending screening mammography at Mountain Park Health Center
  • Speak English or Spanish

Exclusion criteria

  • Male
  • Current diagnosis of breast cancer

Treatment and study plan

Written educational brochure

Behavioral

Written educational brochure about breast density

Promotora interaction

Behavioral

Promotora education about breast density

Primary outcomes

  1. 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)

    Percentage of women who provided an incorrect response as to whether dense breasts impact the ability of a mammogram to correctly detect cancer at T0 but provided a correct response at T1

    Comparisons of the difference between the intervention groups in percentage of women who provided an incorrect response as to whether dense breasts impact the ability of a mammogram to correctly detect cancer at T0 but provided a correct response to the question at T1

  2. Anxiety Short Term (Baseline T0 to First Follow-up T1)

    Time frame: Change from baseline anxiety (T0) to T1: 2 weeks to 180 days after education end

    The State-Trait Anxiety Inventory-State (STAI-S) s a 20-item self-report assessment. Items are answered on a 4-point Likert scale ranging from 1 (not at all) to 4 (very much so), with the total score ranging from 20 to 80, with higher scores indicating higher levels of anxiety symptoms. Anxiety was dichotomized as: normal (STAI score < 30) or moderate to severe (STAI score ≥ 30). The primary outcome was the percentage of participants who maintained or decreased to 'normal' anxiety levels at T1 from T0.

  3. BC Risk Assessment - Survey

    Time frame: T0 (baseline) to T1 (14 to 180 days after completion of education)

    Percentage of women who provided incorrect response at baseline (T0) but a correct response at 14 to 180 days after completion of education to the question: 'Women who have dense breasts are at greater risk for getting breast cancer' (true, false, or I don't know).

    Comparisons of the difference in percentage of women who provided correct response to the single question: 'Women who have dense breasts are at greater risk for getting breast cancer' (true, false, or I don't know) between intervention groups.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Mountain Park Health Center
  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

Latinas LEarning About Density (LLEAD Study)

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Sep 22, 2016
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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