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Empowering Vulnerable and Resilient Latinas to Obtain Breast Cancer Care

Empowering Vulnerable and Resilient Latinas to Obtain Breast Cancer Care

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05483283
Enrollment
600
Registered
2022-08-02
Start date
2023-01-18
Completion date
2027-09-01
Last updated
2026-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Brief summary

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

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

Interventions

OTHEREmpowerment and Navigation

Empowerment and Navigation

OTHERSOC

SOC

Sponsors

University of Illinois at Chicago
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Intervention model description

Empowerment and navigation and Standard of Care (SOC) (Control)

Eligibility

Sex/Gender
FEMALE
Age
30 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Empower and navigation versus SOC4 yearsNumber of participants that undergo risk-based BC screening per ACS guidelines versus the control group

Countries

United States

Contacts

CONTACTYamile Molina, PhD
ymolin2@uic.edu312-355-2679

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026