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NCT02910986 Clinical Trial

Latinas Learning About Density

Breast Cancer Clinical Trial

Official title:
Latinas LEarning About Density (LLEAD Study)

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02910986
Other study ID # 16-003707
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date October 27, 2016
Est. completion date June 30, 2023

Study information
Verified date November 2022
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 1386
Est. completion date June 30, 2023
Est. primary completion date November 15, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 40 Years to 74 Years
Eligibility Inclusion Criteria: - Female - Attending screening mammography at Mountain Park Health Center - Speak English or Spanish Exclusion Criteria: - Male - Current diagnosis of breast cancer

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Written educational brochure
Written educational brochure about breast density
• Promotora interaction
Promotora education about breast density

Locations
Country Name City State
United States Mountain Park Health Center Phoenix Arizona
United States Mayo Clinic in Rochester Rochester Minnesota
United States Mayo Clinic in Arizona Scottsdale Arizona

Sponsors (2)
Lead Sponsor Collaborator
Mayo Clinic Mountain Park Health Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Other Intervention cost Total costs associated with promotora intervention in USD 1 year post density notification
Primary Anxiety Short Term Percent change in State-Trait Anxiety Inventory - State (STAI-S) scores Change from baseline anxiety at 1 month
Primary Breast density knowledge Number of items answered correctly on investigator-derived measure Total knowledge scores at 1 month
Primary Anxiety Longer Term Percent change in STAI-S scores Change from baseline anxiety at 1 year
Secondary Adherence to mammography screening Attendance at next recommended mammogram interval 1 year post density notification
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