Latinas Learning About Density

Study Overview
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Brief Summary
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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
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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.

Official Title
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Latinas LEarning About Density (LLEAD Study)

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: Written educational brochure
* Behavioral: Promotora interaction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female Attending screening mammography at Mountain Park Health Center Speak English or Spanish Exclusion Criteria: Male Current diagnosis of breast cancer

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>Breast density notification using standard language reporting for dense and non-dense breasts within the mammogram results notification letter | |
| Active Comparator: Enhanced<br>Usual Care plus a written educational brochure | Behavioral: Written educational brochure<br>* Written educational brochure about breast density<br>|
| Active Comparator: Interpersonal<br>Usual Care plus Enhanced plus interaction with a promotora (lay health educator) | Behavioral: Written educational brochure<br>* Written educational brochure about breast density<br>Behavioral: Promotora interaction<br>* Promotora education about breast density<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety Short Term | Percent change in State-Trait Anxiety Inventory - State (STAI-S) scores | Change from baseline anxiety at 1 month | 
| Breast density knowledge | Number of items answered correctly on investigator-derived measure | Total knowledge scores at 1 month | 
| Anxiety Longer Term | Percent change in STAI-S scores | Change from baseline anxiety at 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to mammography screening | Attendance at next recommended mammogram interval | 1 year post density notification | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mammography, Breast Density, Hispanic