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Empowering Vulnerable and Resilient Latinas to Obtain Breast Cancer Care

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Empowerment and Navigation
SOC
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Breast Cancer

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of IllinoisRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Arm 1

Arm 2

Arm Description

Empowerment and Navigation

Standard of Care (SOC)

Outcomes

Primary Outcome Measures

Empower and navigation versus SOC
Number of participants that undergo risk-based BC screening per ACS guidelines versus the control group
Empower and navigation versus SOC
Number of participants that undergo recommended genetic services versus the control group

Secondary Outcome Measures

Full Information

First Posted
July 29, 2022
Last Updated
May 18, 2023
Sponsor
University of Illinois at Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT05483283
Brief Title
Empowering Vulnerable and Resilient Latinas to Obtain Breast Cancer Care
Official Title
Empowering Vulnerable and Resilient Latinas to Obtain Breast Cancer Care
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 18, 2023 (Actual)
Primary Completion Date
September 2028 (Anticipated)
Study Completion Date
September 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Empowerment and navigation and Standard of Care (SOC) (Control)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Other
Arm Description
Empowerment and Navigation
Arm Title
Arm 2
Arm Type
Other
Arm Description
Standard of Care (SOC)
Intervention Type
Other
Intervention Name(s)
Empowerment and Navigation
Intervention Description
Empowerment and Navigation
Intervention Type
Other
Intervention Name(s)
SOC
Intervention Description
SOC
Primary Outcome Measure Information:
Title
Empower and navigation versus SOC
Description
Number of participants that undergo risk-based BC screening per ACS guidelines versus the control group
Time Frame
4 years
Title
Empower and navigation versus SOC
Description
Number of participants that undergo recommended genetic services versus the control group
Time Frame
4 years

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yamile Molina, PhD
Phone
312-355-2679
Email
ymolin2@uic.edu
Facility Information:
Facility Name
University of Illinois
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yamile Molina, PhD
Phone
312-355-2679
Email
ymolina2@uic.edu

12. IPD Sharing Statement

Learn more about this trial

Empowering Vulnerable and Resilient Latinas to Obtain Breast Cancer Care

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