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Recruiting

NCT Number: NCT05483283

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

Recruiting

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Key information

Age range

30 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Illinois

Chicago, Illinois, 60612, United States

Location status: Recruiting

Location contact

Yamile Molina, PhD

CONTACT

[email protected]

312-355-2679

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. 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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
  • 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

Exclusion criteria

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

Treatment and study plan

Empowerment and Navigation

Other

Empowerment and Navigation

SOC

Other

SOC

Primary outcomes

  1. 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

  2. Empower and navigation versus SOC

    Time frame: 4 years

    Number of participants that undergo recommended genetic services versus the control group

Study contacts

Contact information is provided by the study sponsor or research team.

Yamile Molina, PhD

CONTACT

[email protected]

312-355-2679

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Aug 2, 2022
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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