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Behavioral and Psychological Impact of Returning Breast Density Results to Latinas

Latinas LEarning About Density (LLEAD Study)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02910986
Enrollment
1386
Registered
2016-09-22
Start date
2016-10-27
Completion date
2019-11-15
Last updated
2025-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Mammography, Breast Density, Hispanic

Brief summary

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.

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.

Interventions

Written educational brochure about breast density

BEHAVIORALPromotora interaction

Promotora education about breast density

Sponsors

Mountain Park Health Center
CollaboratorUNKNOWN
National Institute on Minority Health and Health Disparities (NIMHD)
CollaboratorNIH
Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
40 Years to 74 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* Male * Current diagnosis of breast cancer

Design outcomes

Primary

MeasureTime frameDescription
Knowledge of Breast Density as a Masking Factor at First Follow-upBaseline (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
Anxiety Short Term (Baseline T0 to First Follow-up T1)Change from baseline anxiety (T0) to T1: 2 weeks to 180 days after education endThe 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.
BC Risk Assessment - SurveyT0 (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.

Countries

United States

Participant flow

Pre-assignment details

There were 10 patients who were found to be ineligible (n=2) or withdrew consent prior to randomization.

Participants by arm

ArmCount
Usual Care
Breast density notification using standard language reporting for dense and non-dense breasts within the mammogram results notification letter
349
Enhanced
Usual Care plus a written educational brochure Written educational brochure: Written educational brochure about breast density
334
Interpersonal
Usual Care plus Enhanced plus interaction with a promotora (lay health educator) Written educational brochure: Written educational brochure about breast density Promotora interaction: Promotora education about breast density
260
Total943

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyFailure to return T! survey728472
Overall Studynon-Latina141312
Overall StudyT1 Survey not 14-180 post education2525115
Overall StudyWithdrew after randomization prior to start of intervention002

Baseline characteristics

CharacteristicUsual CareTotalInterpersonalEnhanced
Age, Continuous47 years47 years47 years46 years
Ethnicity (NIH/OMB)
Hispanic or Latino
349 Participants943 Participants260 Participants334 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
349 Participants943 Participants260 Participants334 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants0 Participants
Region of Enrollment
United States
349 participants943 participants260 participants334 participants
Sex: Female, Male
Female
349 Participants943 Participants260 Participants334 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 3490 / 3340 / 260
other
Total, other adverse events
0 / 3490 / 3340 / 260
serious
Total, serious adverse events
0 / 3490 / 3340 / 260

Outcome results

Primary

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

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.

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

Population: 516 Latina participants with complete follow-up over all three time points

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
EnhancedAnxiety Short Term (Baseline T0 to First Follow-up T1)Decreased or stayed normal99 Participants
EnhancedAnxiety Short Term (Baseline T0 to First Follow-up T1)Increased or stayed moderate/severe100 Participants
Usual CareAnxiety Short Term (Baseline T0 to First Follow-up T1)Decreased or stayed normal88 Participants
Usual CareAnxiety Short Term (Baseline T0 to First Follow-up T1)Increased or stayed moderate/severe98 Participants
InterpersonalAnxiety Short Term (Baseline T0 to First Follow-up T1)Decreased or stayed normal70 Participants
InterpersonalAnxiety Short Term (Baseline T0 to First Follow-up T1)Increased or stayed moderate/severe61 Participants
p-value: 0.56Chi-squared
Primary

BC Risk Assessment - Survey

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.

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
EnhancedBC Risk Assessment - Survey114 Participants
Usual CareBC Risk Assessment - Survey110 Participants
InterpersonalBC Risk Assessment - Survey95 Participants
p-value: >0.05Chi-squared
98.3% CI: [-6, 11.2]
98.3% CI: [-4.3, 14.3]
98.3% CI: [-7, 11.9]
Primary

Knowledge of Breast Density as a Masking Factor at First Follow-up

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

Time frame: Baseline (T0) to first follow-up (T1, 2 weeks to 180 days from education end)

Population: 943 participants who completed baseline and first follow-up

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
EnhancedKnowledge of Breast Density as a Masking Factor at First Follow-up101 Participants
Usual CareKnowledge of Breast Density as a Masking Factor at First Follow-up104 Participants
InterpersonalKnowledge of Breast Density as a Masking Factor at First Follow-up100 Participants
Comparison: The percentage with improved knowledge (defined as having an incorrect response at T0 and a correct response at T1) was compared between study groups with chi-square tests.p-value: >0.05Chi-squared

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026