Empowering Vulnerable and Resilient Latinas to Obtain Breast Cancer Care
Empowerment and Navigation
+ SOC
Enfermedades de la Mama+2
+ Neoplasias de la Mama
+ Neoplasias
Estudio de Detección
Resumen
Fecha de inicio: 18 de enero de 2023
Fecha en la que se inscribió al primer participante.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
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 600 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Detección
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Mujer
Sexo biológico de los participantes elegibles para inscribirse.A partir de 30 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
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
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
Grupo II
Objetivos del Estudio
Objetivos Primarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación