Empowering Vulnerable and Resilient Latinas to Obtain Breast Cancer Care

The investigator and study staff will identify, recruit and randomize Latina participants with elevated genetic and Social Determinants of Heath (SDH) risks. Within 1 week of enrollment, all Latina Aim 1 participants in both study arms will engage in three 30-minute, individual, phone-based sessions with the study team across 3 consecutive weeks

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Empowerment and Navigation; Other: SOC

Detailed Description

The investigator and study staff will identify, recruit and randomize Latina participants with elevated genetic and Social Determinants of Heath (SDH) risks. Within 1 week of enrollment, all Latina Aim 1 participants in both study arms will engage in three 30-minute, individual, phone-based sessions with the study team across 3 consecutive weeks. Sessions will be based on landline or cellphone calls. Within 1 week after each session, all Latina Aim 1 participants will receive copies of the multi-media materials (e.g., personalized plans) by text message or mail, depending on participants' preferences

Control Sessions will be as follows:

Session 1 Learning about Breast Cancer (BC) care uptake Targets the effects of Social Determinants of Heath (SDH) and genetic risk factors on Non-Latino White (NLW) Latino BC disparities Study staff will give personnel testimonials, empirical data and individual action plans behavior change and BC care uptake Session 2 Learning about Diet to promote BC prevention per the American Cancer Society (ACS) BC screening and prevention guidelines Session 3 Learning about Physical Activity to promote BC prevention

Empowerment and Navigation Sessions will be as follows:

Session 1 Learning about Breast Cancer (BC) care uptake Targets the effects of SDH and genetic risk factors on NLW/Latino BC disparities ACS BC screening and prevention guidelines Identify and address SDH and genetic risk factors Study staff will give personnel testimonials, empirical data and individual action plans for behavior change Session 2 Teaching about BC Targets the importance of sharing BC information and personal barriers & preferred solutions to sharing BC information Study staff will give personnel testimonials and individual action plans for sharing information and role playing activities Session 3 Teaching about BC Targets opportunities & skills in sharing BC information participants will give testimonials and relay empirical data. There will be a group discussion and plans for sharing information

There will be a post intervention BC survey call and an end of study BC survey call

Bicultural, bilingual study staff will engage participants in a 5-10 minute call/text every month to "check in" until the end of the study

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yamile Molina, PhD; Phone Number: 312-355-2679; Email: ymolin2@uic.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • University of Illinois
      • Contact: Yamile Molina, PhD; Phone Number: 312-355-2679; Email: ymolina2@uic.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Aim 1

1. female biological sex
2. identification as Latina
3. one genetic risk factor (i.e., personal history of breast cancer or family history of breast or ovarian cancer)
4. one SDH risk factor, based on the American Cancer Society's definitions (e.g., perceived financial struggles; transportation difficulties; exposure to violence; housing challenges; social isolation/challenges)
5. 30+ years old, based on American Cancer Society (ACS) screening guidelines for high risk populations
6. No receipt of cancer genetic counseling AND no receipt of genetic testing

Aim 2

1. female biological sex
2. referral from Latina Aim 1 participants
3. eligibility to obtain BC screenings, based on ACS guidelines (e.g., optional annual
4. screenings at 40-44 years old, recommended annual screenings at 45-54 years old, every other year screening at 55 and older)
5. self-report not attending Session #3 (as this will not be recorded by the staff)

Aim 3

1. participant from Aim 1 or
2. participant from Aim 2

Exclusion Criteria:

Aim 1 and Aim 2 Not meeting at least one of the inclusion criteria

Aim 3

1. Not a participant from Aim 1 or
2. Not a participant from Aim 2

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Arm 1; Empowerment and Navigation	Other: Empowerment and Navigation; Empowerment and Navigation
Other: Arm 2; Standard of Care (SOC)	Other: SOC; SOC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Empower and navigation versus SOC	Number of participants that undergo risk-based BC screening per ACS guidelines versus the control group	4 years
Empower and navigation versus SOC	Number of participants that undergo recommended genetic services versus the control group	4 years

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2023
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: July 29, 2022
• First Submitted That Met QC Criteria: July 29, 2022
• First Posted (Actual): August 2, 2022

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 7, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: 2022-0378

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No