Latinas Learning About Density

November 11, 2022 updated by: Celine M. Vachon, 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

Active, not recruiting

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

  • United States
    • 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

Genders Eligible for Study

Female

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
Behavioral: Written educational brochure
Written educational brochure about breast density
Active Comparator: Interpersonal
Usual Care plus Enhanced plus interaction with a promotora (lay health educator)
Behavioral: Written educational brochure
Written educational brochure about breast density
Behavioral: Promotora interaction
Promotora education about breast density

What is the study measuring?

Primary Outcome Measures

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

Mayo Clinic

Collaborators

Mountain Park Health Center

Investigators

  • Principal Investigator: Celine Vachon, 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

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 (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

September 8, 2016

First Submitted That Met QC Criteria

September 20, 2016

First Posted (Estimate)

September 22, 2016

Study Record Updates

Last Update Posted (Actual)

November 14, 2022

Last Update Submitted That Met QC Criteria

November 11, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 16-003707

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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