Empowering Vulnerable and Resilient Latinas to Obtain Breast Cancer Care
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Empower and navigation versus SOC
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
- •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)
- •participant from Aim 1 or
- •participant from Aim 2
排除标准
- •Aim 1 and Aim 2 Not meeting at least one of the inclusion criteria
- •Not a participant from Aim 1 or
- •Not a participant from Aim 2
研究组 & 干预措施
Arm 1
Empowerment and Navigation
干预措施: Empowerment and Navigation (Other)
Arm 2
Standard of Care (SOC)
干预措施: SOC (Other)
结局指标
主要结局
Empower and navigation versus SOC
时间窗: 4 years
Number of participants that undergo risk-based BC screening per ACS guidelines versus the control group
次要结局
未报告次要终点
研究者
Yamile Molina
Prinicipal Investigator
University of Illinois at Chicago