Empowering Vulnerable and Resilient Latinas to Obtain Breast Cancer Care

University of Illinois

Status: Enrolling

Conditions: Breast Cancer

Treatments: Other: Empowerment and Navigation; Other: SOC

Study type: Interventional

Funder types: Other

Identifiers

NCT05483283

2022-0378

Details and patient eligibility

About

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

Full 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

Enrollment: 600 estimated patients

Sex: Female

Ages: 30+ years old

Volunteers: No 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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

600 participants in 2 patient groups

Arm 1

Other group

Description:

Empowerment and Navigation

Treatment:

Other: Empowerment and Navigation

Arm 2

Other group

Description:

Standard of Care (SOC)

Treatment:

Other: SOC