Latinas Learning About Density

• Sponsor: Mayo Clinic (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02910986
• Collaborator: Mountain Park Health Center (Other)
• Enrollment: 1,386
• Locations: 3
• Arms: 3
• Anticipated Duration (Months): 68.1
• Patients Per Site: 462
• Patients Per Site Per Month: 6.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Behavioral: Written educational brochure; Behavioral: Promotora interaction	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 1386 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Health Services Research
• Official Title: Latinas LEarning About Density (LLEAD Study)
• Actual Study Start Date: Oct 27, 2016
• Actual Primary Completion Date: Nov 15, 2019
• Anticipated Study Completion Date: Jun 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Anxiety Short Term [Change from baseline anxiety at 1 month]

   Percent change in State-Trait Anxiety Inventory - State (STAI-S) scores

2. Breast density knowledge [Total knowledge scores at 1 month]

   Number of items answered correctly on investigator-derived measure

3. Anxiety Longer Term [Change from baseline anxiety at 1 year]

   Percent change in STAI-S scores

Secondary Outcome Measures

1. Adherence to mammography screening [1 year post density notification]

   Attendance at next recommended mammogram interval

Other Outcome Measures

1. Intervention cost [1 year post density notification]

   Total costs associated with promotora intervention in USD

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 74 Years
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mountain Park Health Center	Phoenix	Arizona	United States	85004
2	Mayo Clinic in Arizona	Scottsdale	Arizona	United States	85259
3	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic
• Mountain Park Health Center

Investigators

• Principal Investigator: Celine Vachon, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Celine M. Vachon, Principle Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT02910986
• Other Study ID Numbers: 16-003707
• First Posted: Sep 22, 2016
• Last Update Posted: Mar 24, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Celine M. Vachon, Principle Investigator, Mayo Clinic: Mammography; Breast Density; Hispanic

Study Results

No Results Posted as of Mar 24, 2022