Empowering Vulnerable and Resilient Latinas to Obtain Breast Cancer Care
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yamile Molina, PhD
- Phone Number: 312-355-2679
- Email: ymolin2@uic.edu
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- Recruiting
- University of Illinois
-
Contact:
- Yamile Molina, PhD
- Phone Number: 312-355-2679
- Email: ymolina2@uic.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Arm 1
Empowerment and Navigation
|
Empowerment and Navigation
|
|
Other: Arm 2
Standard of Care (SOC)
|
SOC
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
4 years
|
|
Empower and navigation versus SOC
Time Frame: 4 years
|
Number of participants that undergo recommended genetic services versus the control group
|
4 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-0378
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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