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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 sierpnia 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

800

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Stany Zjednoczone
    • Georgia
      • Atlanta, Georgia, Stany Zjednoczone, 30322
        • Rekrutacyjny
        • Emory University Hospital/Winship Cancer Institute
        • Główny śledczy:
          • Michael Chung
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Tak

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Ekranizacja
  • Przydział: Randomizowane
  • Model interwencyjny: Zadanie sekwencyjne
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Aim 1 (focus group)
Participants complete a focus group over 60-90 minutes in support of the identification and selection of EBIs on study.
Inny: Discussion
Complete a focus group
Inne nazwy:
  • Omówić
Eksperymentalny: Aim 2 group I (stakeholder interview, surveys)
Participants complete a stakeholder interview and complete surveys to further inform EBI adaptation and implementation on study.
Inny: Interview - Stakeholder
Complete stakeholder interview
Inny: Survey Administration
Complete EBI adaptation and implementation surveys
Eksperymentalny: 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.
Inny: Survey Administration
Complete EBI adaptation and implementation surveys
Inny: Interview - Key Informant
Complete key informant interview
Aktywny komparator: 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.
Inny: Best Practice
Receive EUC
Inne nazwy:
  • standard opieki
  • standardowa terapia
Inny: Interview - Ancillary studies
Ancillary studies
Inny: Survey Administration - Ancillary studies
Ancillary studies
Eksperymentalny: 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.
Inny: Best Practice
Receive EUC
Inne nazwy:
  • standard opieki
  • standardowa terapia
Inny: Interview - Ancillary studies
Ancillary studies
Inny: Survey Administration - Ancillary studies
Ancillary studies
Behawioralne: Patient Navigation - C Components
Receive adapted m-Health PN strategy C components
Inne nazwy:
  • Program Patient Navigator
Eksperymentalny: 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.
Inny: Best Practice
Receive EUC
Inne nazwy:
  • standard opieki
  • standardowa terapia
Inny: Interview - Ancillary studies
Ancillary studies
Inny: Survey Administration - Ancillary studies
Ancillary studies
Behawioralne: Patient Navigation - B components
Receive adapted m-Health PN strategy B components
Inne nazwy:
  • Program Patient Navigator
Eksperymentalny: 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.
Inny: Best Practice
Receive EUC
Inne nazwy:
  • standard opieki
  • standardowa terapia
Inny: Interview - Ancillary studies
Ancillary studies
Inny: Survey Administration - Ancillary studies
Ancillary studies
Behawioralne: Patient Navigation - C Components
Receive adapted m-Health PN strategy C components
Inne nazwy:
  • Program Patient Navigator
Behawioralne: Patient Navigation - B components
Receive adapted m-Health PN strategy B components
Inne nazwy:
  • Program Patient Navigator
Eksperymentalny: 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.
Inny: Best Practice
Receive EUC
Inne nazwy:
  • standard opieki
  • standardowa terapia
Inny: Interview - Ancillary studies
Ancillary studies
Inny: Survey Administration - Ancillary studies
Ancillary studies
Behawioralne: Patient Navigation - A components
Receive adapted m-Health PN strategy A components
Inne nazwy:
  • Program Patient Navigator
Eksperymentalny: 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.
Inny: Best Practice
Receive EUC
Inne nazwy:
  • standard opieki
  • standardowa terapia
Inny: Interview - Ancillary studies
Ancillary studies
Inny: Survey Administration - Ancillary studies
Ancillary studies
Behawioralne: Patient Navigation - C Components
Receive adapted m-Health PN strategy C components
Inne nazwy:
  • Program Patient Navigator
Behawioralne: Patient Navigation - A components
Receive adapted m-Health PN strategy A components
Inne nazwy:
  • Program Patient Navigator
Eksperymentalny: 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.
Inny: Best Practice
Receive EUC
Inne nazwy:
  • standard opieki
  • standardowa terapia
Inny: Interview - Ancillary studies
Ancillary studies
Inny: Survey Administration - Ancillary studies
Ancillary studies
Behawioralne: Patient Navigation - B components
Receive adapted m-Health PN strategy B components
Inne nazwy:
  • Program Patient Navigator
Behawioralne: Patient Navigation - A components
Receive adapted m-Health PN strategy A components
Inne nazwy:
  • Program Patient Navigator
Eksperymentalny: 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.
Inny: Best Practice
Receive EUC
Inne nazwy:
  • standard opieki
  • standardowa terapia
Inny: Interview - Ancillary studies
Ancillary studies
Inny: Survey Administration - Ancillary studies
Ancillary studies
Behawioralne: Patient Navigation - C Components
Receive adapted m-Health PN strategy C components
Inne nazwy:
  • Program Patient Navigator
Behawioralne: Patient Navigation - B components
Receive adapted m-Health PN strategy B components
Inne nazwy:
  • Program Patient Navigator
Behawioralne: Patient Navigation - A components
Receive adapted m-Health PN strategy A components
Inne nazwy:
  • Program Patient Navigator

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Adapted evidence-based intervention (EBI) delivery strategies (Aim 1)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Time to MMG screening (Aim 3)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Emory University

Współpracownicy

National Cancer Institute (NCI)

Śledczy

  • Główny śledczy: Michael Chung, Emory University Hospital/Winship Cancer Institute

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

22 lipca 2025

Zakończenie podstawowe (Szacowany)

30 czerwca 2028

Ukończenie studiów (Szacowany)

30 czerwca 2029

Daty rejestracji na studia

Pierwszy przesłany

10 sierpnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

10 sierpnia 2026

Pierwszy wysłany (Rzeczywisty)

14 sierpnia 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

14 sierpnia 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

10 sierpnia 2026

Ostatnia weryfikacja

1 sierpnia 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • STUDY00008713 (Inny identyfikator: Emory University Hospital/Winship Cancer Institute)
  • P30CA138292 (Grant/umowa NIH USA)
  • U54CA284036 (Grant/umowa NIH USA)
  • NCI-2025-05473 (Identyfikator rejestru: CTRP (Clinical Trial Reporting Program))
  • EU6635-25 (Inny identyfikator: Emory University Hospital/Winship Cancer Institute)

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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