Behavioral and Psychological Impact of Returning Breast Density Results to Latinas
August 27, 2025 updated by: Mayo Clinic
Latinas LEarning About Density (LLEAD Study)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
1386
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Phoenix, Arizona, United States, 85004
- Mountain Park Health Center
-
Scottsdale, Arizona, United States, 85259
- Mayo Clinic in Arizona
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 74 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Female
- Attending screening mammography at Mountain Park Health Center
- Speak English or Spanish
Exclusion Criteria:
- Male
- Current diagnosis of breast cancer
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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
|
Written educational brochure about breast density
|
|
Active Comparator: Interpersonal
Usual Care plus Enhanced plus interaction with a promotora (lay health educator)
|
Written educational brochure about breast density
Promotora education about breast density
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 |
Baseline (T0) to first follow-up (T1, 2 weeks to 180 days from education end)
|
|
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.
|
Change from baseline anxiety (T0) to T1: 2 weeks to 180 days after education end
|
|
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. |
T0 (baseline) to T1 (14 to 180 days after completion of education)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adherence to mammography screening
Time Frame: 1 year post density notification
|
Attendance at next recommended mammogram interval
|
1 year post density notification
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intervention cost
Time Frame: 1 year post density notification
|
Total costs associated with promotora intervention in USD
|
1 year post density notification
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Celine M. Vachon, Ph.D., Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Patel BK, Ridgeway JL, Ghosh K, Rhodes DJ, Borah B, Jenkins S, Suman VJ, Norman A, Jewett M, Singh D, Vachon CM, Radecki Breitkopf C. Behavioral and psychological impact of returning breast density results to Latinas: study protocol for a randomized clinical trial. Trials. 2019 Dec 18;20(1):744. doi: 10.1186/s13063-019-3939-6.
- Ridgeway JL, Jenkins SM, Borah BJ, Suman VJ, Patel BK, Ghosh K, Rhodes DJ, Norman A, Ramos EP, Jewett M, Gonzalez CR, Hernandez V, Singh D, Sosa M, Radecki Breitkopf C, Vachon CM. Evaluating educational interventions to increase breast density awareness among Latinas: A randomized trial in a Federally Qualified Health Center. Cancer. 2022 Mar 1;128(5):1038-1047. doi: 10.1002/cncr.34017. Epub 2021 Dec 2.
- Patel BK, Ridgeway JL, Jenkins S, Rhodes DJ, Ghosh K, Borah B, Suman V, Norman A, Leaver J, Jewett M, Hruska C, Gonzalez C, Singh D, Vachon CM, Breitkopf CR. Breast Density Knowledge and Awareness Among Latinas in a Low-Resource Setting. J Am Coll Radiol. 2022 Jan;19(1 Pt B):155-161. doi: 10.1016/j.jacr.2021.08.025.
- Austin JD, Jenkins SM, Suman VJ, Raygoza JP, Ridgeway JL, Norman A, Gonzalez C, Hernandez V, Ghosh K, Patel BK, Vachon CM. Breast Cancer Risk Perceptions Among Underserved, Hispanic Women: Implications for Risk-Based Approaches to Screening. J Racial Ethn Health Disparities. 2025 Apr;12(2):1150-1158. doi: 10.1007/s40615-024-01949-7. Epub 2024 Feb 21.
- Ghosh K, Jenkins SM, Ridgeway JL, Austin JD, Borah BJ, Patel B, Rhodes DJ, Norman AD, Ramos EP, Jewett M, Gonzalez CR, Hernandez V, Singh D, Vachon CM, Suman VJ. A randomized trial to evaluate the impact of breast density notification on anxiety, breast cancer worry, and perceived risk among Latinas at a federally qualified health center : Breast density notification and anxiety, breast cancer worry, and perceived risk among Latinas. BMC Womens Health. 2025 Jun 2;25(1):274. doi: 10.1186/s12905-025-03818-9.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 27, 2016
Primary Completion (Actual)
November 15, 2019
Study Completion (Actual)
November 15, 2019
Study Registration Dates
First Submitted
September 8, 2016
First Submitted That Met QC Criteria
September 20, 2016
First Posted (Estimated)
September 22, 2016
Study Record Updates
Last Update Posted (Estimated)
August 28, 2025
Last Update Submitted That Met QC Criteria
August 27, 2025
Last Verified
May 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-003707
- R01MD009682 (U.S. NIH Grant/Contract)
- MC1936 (Other Identifier: Mayo Clinic)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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