NCT05483283

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
15mo left

Started Jan 2023

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
Jan 2023Sep 2027

First Submitted

Initial submission to the registry

July 29, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 2, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

January 18, 2023

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

4.6 years

First QC Date

July 29, 2022

Last Update Submit

March 7, 2026

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Arm 1

OTHER

Empowerment and Navigation

Other: Empowerment and Navigation

Arm 2

OTHER

Standard of Care (SOC)

Other: SOC

Interventions

Empowerment and NavigationOTHER

Empowerment and Navigation

Arm 1
SOCOTHER

SOC

Arm 2

Eligibility Criteria

Age30 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aim 1
  • female biological sex
  • identification as Latina
  • one genetic risk factor (i.e., personal history of breast cancer or family history of breast or ovarian cancer)
  • 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)
  • + years old, based on American Cancer Society (ACS) screening guidelines for high risk populations
  • No receipt of cancer genetic counseling AND no receipt of genetic testing
  • Aim 2
  • female biological sex
  • referral from Latina Aim 1 participants
  • eligibility to obtain BC screenings, based on ACS guidelines (e.g., optional annual
  • screenings at 40-44 years old, recommended annual screenings at 45-54 years old, every other year screening at 55 and older)
  • self-report not attending Session #3 (as this will not be recorded by the staff)
  • Aim 3
  • participant from Aim 1 or
  • +1 more criteria

You may not qualify if:

  • Aim 3
  • Not a participant from Aim 1 or
  • Not a participant from Aim 2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois

Chicago, Illinois, 60612, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Yamile Molina, PhD

CONTACT

312-355-2679ymolin2@uic.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: Empowerment and navigation and Standard of Care (SOC) (Control)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prinicipal Investigator

Study Record Dates

First Submitted

July 29, 2022

First Posted

August 2, 2022

Study Start

January 18, 2023

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

March 10, 2026

Record last verified: 2026-03

Locations

US(1)