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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 août 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

800

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Georgia
      • Atlanta, Georgia, États-Unis, 30322
        • Recrutement
        • Emory University Hospital/Winship Cancer Institute
        • Chercheur principal:
          • Michael Chung
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Oui

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Dépistage
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation séquentielle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Aim 1 (focus group)
Participants complete a focus group over 60-90 minutes in support of the identification and selection of EBIs on study.
Autre: Discussion
Complete a focus group
Autres noms:
  • Discuter
Expérimental: Aim 2 group I (stakeholder interview, surveys)
Participants complete a stakeholder interview and complete surveys to further inform EBI adaptation and implementation on study.
Autre: Interview - Stakeholder
Complete stakeholder interview
Autre: Survey Administration
Complete EBI adaptation and implementation surveys
Expérimental: 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.
Autre: Survey Administration
Complete EBI adaptation and implementation surveys
Autre: Interview - Key Informant
Complete key informant interview
Comparateur actif: 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.
Autre: Best Practice
Receive EUC
Autres noms:
  • norme de soins
  • thérapie standard
Autre: Interview - Ancillary studies
Ancillary studies
Autre: Survey Administration - Ancillary studies
Ancillary studies
Expérimental: 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.
Autre: Best Practice
Receive EUC
Autres noms:
  • norme de soins
  • thérapie standard
Autre: Interview - Ancillary studies
Ancillary studies
Autre: Survey Administration - Ancillary studies
Ancillary studies
Comportemental: Patient Navigation - C Components
Receive adapted m-Health PN strategy C components
Autres noms:
  • Programme de navigateur des patients
Expérimental: 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.
Autre: Best Practice
Receive EUC
Autres noms:
  • norme de soins
  • thérapie standard
Autre: Interview - Ancillary studies
Ancillary studies
Autre: Survey Administration - Ancillary studies
Ancillary studies
Comportemental: Patient Navigation - B components
Receive adapted m-Health PN strategy B components
Autres noms:
  • Programme de navigateur des patients
Expérimental: 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.
Autre: Best Practice
Receive EUC
Autres noms:
  • norme de soins
  • thérapie standard
Autre: Interview - Ancillary studies
Ancillary studies
Autre: Survey Administration - Ancillary studies
Ancillary studies
Comportemental: Patient Navigation - C Components
Receive adapted m-Health PN strategy C components
Autres noms:
  • Programme de navigateur des patients
Comportemental: Patient Navigation - B components
Receive adapted m-Health PN strategy B components
Autres noms:
  • Programme de navigateur des patients
Expérimental: 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.
Autre: Best Practice
Receive EUC
Autres noms:
  • norme de soins
  • thérapie standard
Autre: Interview - Ancillary studies
Ancillary studies
Autre: Survey Administration - Ancillary studies
Ancillary studies
Comportemental: Patient Navigation - A components
Receive adapted m-Health PN strategy A components
Autres noms:
  • Programme de navigateur des patients
Expérimental: 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.
Autre: Best Practice
Receive EUC
Autres noms:
  • norme de soins
  • thérapie standard
Autre: Interview - Ancillary studies
Ancillary studies
Autre: Survey Administration - Ancillary studies
Ancillary studies
Comportemental: Patient Navigation - C Components
Receive adapted m-Health PN strategy C components
Autres noms:
  • Programme de navigateur des patients
Comportemental: Patient Navigation - A components
Receive adapted m-Health PN strategy A components
Autres noms:
  • Programme de navigateur des patients
Expérimental: 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.
Autre: Best Practice
Receive EUC
Autres noms:
  • norme de soins
  • thérapie standard
Autre: Interview - Ancillary studies
Ancillary studies
Autre: Survey Administration - Ancillary studies
Ancillary studies
Comportemental: Patient Navigation - B components
Receive adapted m-Health PN strategy B components
Autres noms:
  • Programme de navigateur des patients
Comportemental: Patient Navigation - A components
Receive adapted m-Health PN strategy A components
Autres noms:
  • Programme de navigateur des patients
Expérimental: 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.
Autre: Best Practice
Receive EUC
Autres noms:
  • norme de soins
  • thérapie standard
Autre: Interview - Ancillary studies
Ancillary studies
Autre: Survey Administration - Ancillary studies
Ancillary studies
Comportemental: Patient Navigation - C Components
Receive adapted m-Health PN strategy C components
Autres noms:
  • Programme de navigateur des patients
Comportemental: Patient Navigation - B components
Receive adapted m-Health PN strategy B components
Autres noms:
  • Programme de navigateur des patients
Comportemental: Patient Navigation - A components
Receive adapted m-Health PN strategy A components
Autres noms:
  • Programme de navigateur des patients

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Adapted evidence-based intervention (EBI) delivery strategies (Aim 1)
Délai: 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)
Délai: 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.
Up to 4 years
Access to screening mammography (MMG) for eligible asymptomatic women (Aim 3)
Délai: 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)
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Time to MMG screening (Aim 3)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Emory University

Collaborateurs

National Cancer Institute (NCI)

Les enquêteurs

  • Chercheur principal: Michael Chung, Emory University Hospital/Winship Cancer Institute

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

22 juillet 2025

Achèvement primaire (Estimé)

30 juin 2028

Achèvement de l'étude (Estimé)

30 juin 2029

Dates d'inscription aux études

Première soumission

10 août 2026

Première soumission répondant aux critères de contrôle qualité

10 août 2026

Première publication (Réel)

14 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

14 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

10 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • STUDY00008713 (Autre identifiant: Emory University Hospital/Winship Cancer Institute)
  • P30CA138292 (Subvention/contrat des NIH des États-Unis)
  • U54CA284036 (Subvention/contrat des NIH des États-Unis)
  • NCI-2025-05473 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))
  • EU6635-25 (Autre identifiant: Emory University Hospital/Winship Cancer Institute)

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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