Empowering Vulnerable and Resilient Latinas to Obtain Breast Cancer Care
Empowerment and Navigation
+ SOC
Maladies du sein+3
+ Néoplasmes du sein
+ Néoplasmes par site
Étude de screening
Résumé
Date de début de l'étude : 18 janvier 2023
Date à laquelle le premier participant a commencé l'étude.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
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.600 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Screening
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Femme
Le sexe biologique des participants éligibles à s'inscrire.À partir de 30 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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 l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.2 groupes d'intervention sont désignés dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
Groupe II
Objectifs de l'étude
Objectifs principaux
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site