Recruiting

Observational Study

Sponsor:

University of Illinois at Chicago

Code:

NCT05483283

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 30+

Healthy Volunteers: Not accepted

Interventions

Empowerment and Navigation

SOC

Study Details

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

Conditions

Breast Cancer

Study ID

NCT05483283

Start date

Jan 18, 2023

Status verified date

Mar, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 30+

Healthy Volunteers: Not accepted

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 Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

other: Arm 1

Empowerment and Navigation

other: Arm 2

Standard of Care (SOC)

Interventions

Empowerment and Navigation

Empowerment and Navigation

SOC

SOC

Primary outcome measure

  • Empower and navigation versus SOC [ Time Frame: 4 years ]
  • Empower and navigation versus SOC [ Time Frame: 4 years ]

Central Contacts and Locations

Central contacts

Locations

University of Illinois

Recruiting

Chicago, Illinois, United States, 60612

Contacts

More Information

Sponsor

University of Illinois at Chicago

Last update posted

Mar 10, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Illinois at Chicago on 2026-03-10.