Breast CancerNCT05483283
Empowering Vulnerable and Resilient Latinas to Obtain Breast Cancer Care
A study testing Empowerment and Navigation and SOC in people with Breast Cancer, run by University of Illinois Chicago at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Empowerment and Navigation and SOC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2023to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
- 30+ years old, based on American Cancer Society (ACS) screening guidelines for high risk populations
Show all 16Show fewer
- 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
- participant from Aim 2
Who cannot join
- Aim 1 and Aim 2 Not meeting at least one of the inclusion criteria
- Aim 3
- Not a participant from Aim 1 or
- Not a participant from Aim 2
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Illinois
Chicago, Illinois, 60612
Yamile Molina, PhD, 312-355-2679, ymolina2@uic.edu
About this study
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
Read the 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
- Conditions
- Breast Cancer
- Being tested
- Empowerment and Navigation, SOC
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empowerment and NavigationOther
Empowerment and Navigation
SOCOther
SOC
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Empowerment and Navigation Receives: Other: Empowerment and Navigation |
| Arm 2 | Other | Standard of Care (SOC) Receives: Other: SOC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Empower and navigation versus SOC
Number of participants that undergo risk-based BC screening per ACS guidelines versus the control group
Measured: 4 years
Empower and navigation versus SOC
Number of participants that undergo recommended genetic services versus the control group
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start18 Jan 2023
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Empowerment and navigation and Standard of Care (SOC) (Control)
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yamile Molina, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05483283
- Sponsor's protocol ID
- 2022-0378
- Status last verified
- Mar 2026
- First submitted
- 29 Jul 2022
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empowering Vulnerable and Resilient Latinas to Obtain Breast Cancer Care
- ClinicalTrials.gov ID
- NCT05483283
- Acronym / sponsor ID
- 2022-0378
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 18 Jan 2023 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 2 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Empowerment and navigation and Standard of Care (SOC) (Control)
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Other: Empowerment and NavigationEmpowerment and Navigation |
| Arm 2 | Other | Other: SOCStandard of Care (SOC) |
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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)
Key exclusion criteria (4 listed)
- Aim 1 and Aim 2 Not meeting at least one of the inclusion criteria
- Aim 3
- Not a participant from Aim 1 or
- Not a participant from Aim 2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empowerment and NavigationEmpowerment and Navigation | Other | Arm 1 |
| SOCSOC | Other | Arm 2 |
Primary outcome
Empower and navigation versus SOC
Time frame: 4 years
Number of participants that undergo risk-based BC screening per ACS guidelines versus the control group
Empower and navigation versus SOC
Time frame: 4 years
Number of participants that undergo recommended genetic services versus the control group
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
Related trials for Breast Cancer
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
RecruitingPhase 1/2
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Metastatic Breast Cancer
RecruitingObservational study
Clinical Database of Safe Personalized Adjuvant Breast Radiotherapy Based on Individual Radiosensitivity
Breast Cancer
RecruitingPhase 2
BRE-04: Window of Opportunity Trial of Preoperative Low Dose Azacitidine in High-Risk Early Stage Breast Cancer
Breast Cancer Invasive, Early-stage Breast Cancer
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Empowerment and Navigation and SOC in people with Breast Cancer, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yamile Molina, PhD (312-355-2679, ymolin2@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Empower and navigation versus SOC (time frame: 4 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.