Clinical trial NCT05483283: 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
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2022-08-02
Enrollment: 600
Sex: FEMALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Empowerment and navigation and Standard of Care (SOC) (Control)
Primary purpose: SCREENING

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

Eligibility criteria: 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

Primary outcomes:
measure: Empower and navigation versus SOC
timeFrame: 4 years
measure: Empower and navigation versus SOC
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois
state: Illinois
Study officials:
References: