Mobile Health Patient Navigation for the Improvement of Screening and the Early Detection of Breast Cancer in Women Accessing Primary Care Clinics in Kenya
10 de agosto de 2026 actualizado por: Michael H Chung, Emory University
A Multi-Level Strategy for Integrating Information Technology and Mobile Health to Strengthen Linkages to Breast Cancer Screening and Early Detection Among Women Utilizing Primary Care in Kenya (MATITI YANGU)
This clinical trial develops and studies how well mobile health (m-Health) patient navigation (PN) strategies work to improve screening and the early detection of breast cancer in women accessing primary care clinics in Kenya.
Although highly curable, breast cancer kills thousands of women in developing countries yearly.
Mammography (MMG) is used for the early detection of breast cancer by creating a picture of the breast using film or a computer.
Despite the availability of MMG in all 47 counties in Kenya, screening remains low in eligible women.
Early detection of breast cancer may also be improved through access to high quality clinical breast exams (CBE).
However, primary care providers in Kenya face barriers to incorporating CBE into practice, including limited patient awareness of breast cancer screening.
m-Health uses applications on mobile phones to deliver PN directly to the patients.
The PN strategies in this study include digital platforms and tools to help with education, reminders, navigation, and motivation around breast cancer screening.
This may improve screening and the early detection of breast cancer in women accessing primary care clinics in Kenya.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
- Otro: Discussion
- Otro: Interview - Stakeholder
- Otro: Survey Administration
- Otro: Interview - Key Informant
- Otro: Best Practice
- Otro: Interview - Ancillary studies
- Otro: Survey Administration - Ancillary studies
- Conductual: Patient Navigation - C Components
- Conductual: Patient Navigation - B components
- Conductual: Patient Navigation - A components
Descripción detallada
PRIMARY OBJECTIVES:
I. To design and evaluate a multi-component, multi-level, evidence-informed, m-Health-supported package of interventions and delivery strategies to promote uptake and access to resource stratified and guideline-informed breast cancer screening and early detection services in Kenya.
II. To identify and select candidate interventions that are effective in promoting uptake and access to breast cancer screening and early detection.
III. To implement a package and strategies of m-Health supported evidence-based interventions for screening and early detection of breast cancer.
IV. To evaluate feasibility (recruitment, retention, implementation) of each strategy, and identify the most effective strategy (or combination of strategies), for the lowest cost.
OUTLINE:
AIM 1: Participants complete a focus group over 60-90 minutes in support of the identification and selection of evidence-based interventions (EBIs) on study.
AIM 2: Participants are assigned to 1 of 2 groups.
GROUP I: Participants complete a stakeholder interview and complete surveys to further inform EBI adaptation and implementation on study.
GROUP II: Participants complete a key informant interview and complete surveys to further inform EBI adaptation and implementation on study.
AIM 3: Patients are randomized to 1 of 8 arms.
ARM 1: Patients receive enhanced usual care (EUC) which may consist of viewing a motivational and educational peer testimonial video, motivational interviewing regarding breast health and cancer screening, and/or being offered clinical breast examination (CBE) access followed by standardized follow-up counseling about screening MMG or guideline-based recommendations on the need for further diagnostic testing on study.
ARM 2: Patients receive EUC as in arm I and adapted m-Health PN strategy C components on study.
ARM 3: Patients receive EUC as in arm I and adapted m-Health PN strategy B components on study.
ARM 4: Patients receive EUC as in arm I and adapted m-Health PN strategy B and C components on study.
ARM 5: Patients receive EUC as in arm I and adapted m-Health PN strategy A components on study.
ARM 6: Patients receive EUC as in arm I and adapted m-Health PN strategy A and C components on study.
ARM 7: Patients receive EUC as in arm I and adapted m-Health PN strategy A and B components on study.
ARM 8: Patients receive EUC as in arm I and adapted m-Health PN strategy A, B, and C components on study.
After completion of study intervention, patients are followed up at 3 and 6 months and at study completion.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
800
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Georgia
-
Atlanta, Georgia, Estados Unidos, 30322
- Reclutamiento
- Emory University Hospital/Winship Cancer Institute
-
Investigador principal:
- Michael Chung
-
Contacto:
- Michael Chung
- Número de teléfono: 404-251-4012
- Correo electrónico: michael.h.chung@emory.edu
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
Inclusion Criteria:
- AIM 1: All members of BREAKTHROUGH's Stakeholder Advisory Board (SAB) breast cancer working group
- AIM 1: Participants (patients and health providers) from primary health care clinics in Nairobi County
- AIM 1: Will include women (patients) aged over 35 years and speak either Kiswahili or English
AIM 1: Include women who:
- Have never undergone MMG screening
- Previously undergone MMG screening
- Experienced breast abnormalities and have been referred for or undergone diagnostic investigations
- Are currently undergoing or have received breast cancer treatment
- AIM 1: Health care providers and breast screening facility staff (i.e. primary care clinic nurses, MMG clinic staff and technicians) will also be recruited
- AIM 2: Will engage with a diverse group of local and national interagency stakeholders, Nairobi County health leadership, and health providers across different levels of the health system
- AIM 3: Women aged 35 years and older who are able to provide informed consent who are attending the outpatient clinics for primary health care
- AIM 4: Members of SAB breast cancer group, health facilities leadership (all health facility levels)
Exclusion Criteria:
- AIM 1: Those who will be unwilling to consent and those who are unable to consent will be excluded from the study
- AIM 2: Those who will be unwilling to consent and those who are unable to consent will be excluded from the study
- AIM 3: Women undergoing breast cancer treatment and women aged 70 years and above will be excluded
- AIM 4: Members of SAB breast cancer group, and health facilities leadership who will be unwilling and unable to consent will be excluded
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Poner en pantalla
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Aim 1 (focus group)
Participants complete a focus group over 60-90 minutes in support of the identification and selection of EBIs on study.
|
Complete a focus group
Otros nombres:
|
|
Experimental: Aim 2 group I (stakeholder interview, surveys)
Participants complete a stakeholder interview and complete surveys to further inform EBI adaptation and implementation on study.
|
Complete stakeholder interview
Complete EBI adaptation and implementation surveys
|
|
Experimental: Aim 2 group II (key informant interview, surveys)
Participants complete a key informant interview and complete surveys to further inform EBI adaptation and implementation on study.
|
Complete EBI adaptation and implementation surveys
Complete key informant interview
|
|
Comparador activo: Aim 3 arm 1 (EUC)
Patients receive EUC which may consist of viewing a motivational and educational peer testimonial video, motivational interviewing regarding breast health and cancer screening, and/or being offered CBE access followed by standardized follow-up counseling about screening MMG or guideline-based recommendations on the need for further diagnostic testing on study.
|
Receive EUC
Otros nombres:
Ancillary studies
Ancillary studies
|
|
Experimental: Aim 3 arm 2 (EUC, PN strategy C)
Patients receive EUC as in arm I and adapted m-Health PN strategy C components on study.
|
Receive EUC
Otros nombres:
Ancillary studies
Ancillary studies
Receive adapted m-Health PN strategy C components
Otros nombres:
|
|
Experimental: Aim 3 arm 3 (EUC, PN strategy B)
Patients receive EUC as in arm I and adapted m-Health PN strategy B components on study.
|
Receive EUC
Otros nombres:
Ancillary studies
Ancillary studies
Receive adapted m-Health PN strategy B components
Otros nombres:
|
|
Experimental: Aim 3 arm 4 (EUC, PN strategy B and C)
Patients receive EUC as in arm I and adapted m-Health PN strategy B and C components on study.
|
Receive EUC
Otros nombres:
Ancillary studies
Ancillary studies
Receive adapted m-Health PN strategy C components
Otros nombres:
Receive adapted m-Health PN strategy B components
Otros nombres:
|
|
Experimental: Aim 3 arm 5 (EUC, PN strategy A)
Patients receive EUC as in arm I and adapted m-Health PN strategy A components on study.
|
Receive EUC
Otros nombres:
Ancillary studies
Ancillary studies
Receive adapted m-Health PN strategy A components
Otros nombres:
|
|
Experimental: Aim 3 arm 6 (EUC, PN strategy A and C)
Patients receive EUC as in arm I and adapted m-Health PN strategy A and C components on study.
|
Receive EUC
Otros nombres:
Ancillary studies
Ancillary studies
Receive adapted m-Health PN strategy C components
Otros nombres:
Receive adapted m-Health PN strategy A components
Otros nombres:
|
|
Experimental: Aim 3 arm 7 (EUC, PN strategy A and B)
Patients receive EUC as in arm I and adapted m-Health PN strategy A and B components on study.
|
Receive EUC
Otros nombres:
Ancillary studies
Ancillary studies
Receive adapted m-Health PN strategy B components
Otros nombres:
Receive adapted m-Health PN strategy A components
Otros nombres:
|
|
Experimental: Aim 3 arm 8 (EUC, PN strategy A, B, and C)
Patients receive EUC as in arm I and adapted m-Health PN strategy A, B, and C components on study.
|
Receive EUC
Otros nombres:
Ancillary studies
Ancillary studies
Receive adapted m-Health PN strategy C components
Otros nombres:
Receive adapted m-Health PN strategy B components
Otros nombres:
Receive adapted m-Health PN strategy A components
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Adapted evidence-based intervention (EBI) delivery strategies (Aim 1)
Periodo de tiempo: Up to 2 years
|
The research team will have two independent members who will translate and code the transcripts of the focus group discussions (FGDs).
They will be using the Capability, Opportunity, and Motivation-based Behavior model to categorize and code the barriers and opportunities associated with the implementation of candidate evidence-based intervention.
Topic prompts related to factors that facilitate EBI implementation will be thematically coded to inform selection and adaptation of EBI delivery (implementation) strategies.
|
Up to 2 years
|
|
Health system resources, training, and requirements for EBI implementation (Aim 2)
Periodo de tiempo: Up to 4 years
|
Will use descriptive statistics to analyze quantitative data from the Service Availability and Readiness Assessment survey, service mapping, Technology Acceptance Model, and Organizational Readiness for Implementing Change.
FGDs and key informant interviews will be digitally recorded, transcribed, then translated into English by an experienced study translator.
Experienced study team members, supported by trainees, will develop codebooks using an iterative, abductive technique, which allows coders to reference the Consolidated Framework for Implementation Research (CFIR), the process will involve remaining receptive to informative deviations.
The coding process will start with reading the transcripts individually to detect initial themes, patterns, and questions that can generate ideas.
Then, focused coding will be conducted to identify concepts that cluster together, organize thoughts, identify major themes that emerge, and connect them to relevant CFIR constructs.
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Up to 4 years
|
|
Access to screening mammography (MMG) for eligible asymptomatic women (Aim 3)
Periodo de tiempo: Up to 6 months
|
The primary method of data collection will be through verification of completion of navigation points in the care pathway of each participant.
The data will also be verified by a trained research assistant at 3 and 6 months and study completion through review of medical records in the health facilities and phone communication audits with the participants.
Will utilize blinded outcome assessors to check for fidelity and other outcomes that require data collection for verification through manual review of facility medical records (paper-based patient registers).
|
Up to 6 months
|
|
Access to diagnostic MMG or breast ultrasound for women who have a breast abnormality identified on clinical breast examination offered at the clinic (Aim 3)
Periodo de tiempo: Up to 6 months
|
The primary method of data collection will be through verification of completion of navigation points in the care pathway of each participant.
The data will also be verified by a trained research assistant at 3 and 6 months and study completion through review of medical records in the health facilities and phone communication audits with the participants.
Will utilize blinded outcome assessors to check for fidelity and other outcomes that require data collection for verification through manual review of facility medical records (paper-based patient registers).
|
Up to 6 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Time to MMG screening (Aim 3)
Periodo de tiempo: Up to 2 years
|
The primary method of data collection will be through verification of completion of navigation points in the care pathway of each participant.
The data will also be verified by a trained research assistant at 3 and 6 months and study completion through review of medical records in the health facilities and phone communication audits with the participants.
Will utilize blinded outcome assessors to check for fidelity and other outcomes that require data collection for verification through manual review of facility medical records (paper-based patient registers).
|
Up to 2 years
|
|
Time to diagnostic MMG (Aim 3)
Periodo de tiempo: Up to 2 years
|
The primary method of data collection will be through verification of completion of navigation points in the care pathway of each participant.
The data will also be verified by a trained research assistant at 3 and 6 months and study completion through review of medical records in the health facilities and phone communication audits with the participants.
Will utilize blinded outcome assessors to check for fidelity and other outcomes that require data collection for verification through manual review of facility medical records (paper-based patient registers).
|
Up to 2 years
|
|
Time to breast ultrasound (Aim 3)
Periodo de tiempo: Up to 2 years
|
The primary method of data collection will be through verification of completion of navigation points in the care pathway of each participant.
The data will also be verified by a trained research assistant at 3 and 6 months and study completion through review of medical records in the health facilities and phone communication audits with the participants.
Will utilize blinded outcome assessors to check for fidelity and other outcomes that require data collection for verification through manual review of facility medical records (paper-based patient registers).
|
Up to 2 years
|
|
Time to breast biopsy (if required) (Aim 3)
Periodo de tiempo: Up to 2 years
|
The primary method of data collection will be through verification of completion of navigation points in the care pathway of each participant.
The data will also be verified by a trained research assistant at 3 and 6 months and study completion through review of medical records in the health facilities and phone communication audits with the participants.
Will utilize blinded outcome assessors to check for fidelity and other outcomes that require data collection for verification through manual review of facility medical records (paper-based patient registers).
|
Up to 2 years
|
|
Time to participant receipt of screening MMG result (Aim 3)
Periodo de tiempo: Up to 2 years
|
The primary method of data collection will be through verification of completion of navigation points in the care pathway of each participant.
The data will also be verified by a trained research assistant at 3 and 6 months and study completion through review of medical records in the health facilities and phone communication audits with the participants.
Will utilize blinded outcome assessors to check for fidelity and other outcomes that require data collection for verification through manual review of facility medical records (paper-based patient registers).
|
Up to 2 years
|
|
Time to receipt of ultrasound and/or biopsy result (Aim 3)
Periodo de tiempo: Up to 2 years
|
The primary method of data collection will be through verification of completion of navigation points in the care pathway of each participant.
The data will also be verified by a trained research assistant at 3 and 6 months and study completion through review of medical records in the health facilities and phone communication audits with the participants.
Will utilize blinded outcome assessors to check for fidelity and other outcomes that require data collection for verification through manual review of facility medical records (paper-based patient registers).
|
Up to 2 years
|
|
Proportion of participants who receive access to the entire (or partial) screening and diagnosis care pathway (Aim 3)
Periodo de tiempo: Up to 2 years
|
The primary method of data collection will be through verification of completion of navigation points in the care pathway of each participant.
The data will also be verified by a trained research assistant at 3 and 6 months and study completion through review of medical records in the health facilities and phone communication audits with the participants.
Will utilize blinded outcome assessors to check for fidelity and other outcomes that require data collection for verification through manual review of facility medical records (paper-based patient registers).
|
Up to 2 years
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Michael Chung, Emory University Hospital/Winship Cancer Institute
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
22 de julio de 2025
Finalización primaria (Estimado)
30 de junio de 2028
Finalización del estudio (Estimado)
30 de junio de 2029
Fechas de registro del estudio
Enviado por primera vez
10 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
10 de agosto de 2026
Publicado por primera vez (Actual)
14 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
14 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
10 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Neoplasias por sitio
- Neoplasias
- Enfermedades de la piel
- Enfermedades de los senos
- Enfermedades de la piel y del tejido conectivo
- Neoplasias de mama
- Administración de Servicios de Salud
- Calidad, acceso y evaluación de la atención médica
- Calidad de la atención médica
- Indicadores de calidad, atención médica
- Pautas como tema
- Garantía de calidad, atención médica
- Gestión de atención al paciente
- Atención médica integral
- Atención centrada en el paciente
- Atención primaria de salud
- Estándar de cuidado
- Directrices de práctica como tema
- Navegación del paciente
Otros números de identificación del estudio
- STUDY00008713 (Otro identificador: Emory University Hospital/Winship Cancer Institute)
- P30CA138292 (Subvención/contrato del NIH de EE. UU.)
- U54CA284036 (Subvención/contrato del NIH de EE. UU.)
- NCI-2025-05473 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
- EU6635-25 (Otro identificador: Emory University Hospital/Winship Cancer Institute)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .