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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

2026. augusztus 10. frissítette: 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.

A tanulmány áttekintése

Állapot

Toborzás

Körülmények

Beavatkozás / kezelés

Részletes leírás

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.

Tanulmány típusa

Beavatkozó

Beiratkozás (Becsült)

800

Fázis

  • Nem alkalmazható

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi helyek

  • Egyesült Államok
    • Georgia
      • Atlanta, Georgia, Egyesült Államok, 30322
        • Toborzás
        • Emory University Hospital/Winship Cancer Institute
        • Kutatásvezető:
          • Michael Chung
        • Kapcsolatba lépni:

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

  • Felnőtt
  • Idősebb felnőtt

Egészséges önkénteseket fogad

Igen

Leírás

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

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Szűrés
  • Kiosztás: Véletlenszerűsített
  • Beavatkozó modell: Szekvenciális hozzárendelés
  • Maszkolás: Egyetlen

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Kísérleti: Aim 1 (focus group)
Participants complete a focus group over 60-90 minutes in support of the identification and selection of EBIs on study.
Egyéb: Discussion
Complete a focus group
Más nevek:
  • Beszéljétek meg
Kísérleti: Aim 2 group I (stakeholder interview, surveys)
Participants complete a stakeholder interview and complete surveys to further inform EBI adaptation and implementation on study.
Egyéb: Interview - Stakeholder
Complete stakeholder interview
Egyéb: Survey Administration
Complete EBI adaptation and implementation surveys
Kísérleti: 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.
Egyéb: Survey Administration
Complete EBI adaptation and implementation surveys
Egyéb: Interview - Key Informant
Complete key informant interview
Aktív összehasonlító: 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.
Egyéb: Best Practice
Receive EUC
Más nevek:
  • az ellátás színvonala
  • standard terápia
Egyéb: Interview - Ancillary studies
Ancillary studies
Egyéb: Survey Administration - Ancillary studies
Ancillary studies
Kísérleti: 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.
Egyéb: Best Practice
Receive EUC
Más nevek:
  • az ellátás színvonala
  • standard terápia
Egyéb: Interview - Ancillary studies
Ancillary studies
Egyéb: Survey Administration - Ancillary studies
Ancillary studies
Viselkedési: Patient Navigation - C Components
Receive adapted m-Health PN strategy C components
Más nevek:
  • Patient Navigator Program
Kísérleti: 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.
Egyéb: Best Practice
Receive EUC
Más nevek:
  • az ellátás színvonala
  • standard terápia
Egyéb: Interview - Ancillary studies
Ancillary studies
Egyéb: Survey Administration - Ancillary studies
Ancillary studies
Viselkedési: Patient Navigation - B components
Receive adapted m-Health PN strategy B components
Más nevek:
  • Patient Navigator Program
Kísérleti: 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.
Egyéb: Best Practice
Receive EUC
Más nevek:
  • az ellátás színvonala
  • standard terápia
Egyéb: Interview - Ancillary studies
Ancillary studies
Egyéb: Survey Administration - Ancillary studies
Ancillary studies
Viselkedési: Patient Navigation - C Components
Receive adapted m-Health PN strategy C components
Más nevek:
  • Patient Navigator Program
Viselkedési: Patient Navigation - B components
Receive adapted m-Health PN strategy B components
Más nevek:
  • Patient Navigator Program
Kísérleti: 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.
Egyéb: Best Practice
Receive EUC
Más nevek:
  • az ellátás színvonala
  • standard terápia
Egyéb: Interview - Ancillary studies
Ancillary studies
Egyéb: Survey Administration - Ancillary studies
Ancillary studies
Viselkedési: Patient Navigation - A components
Receive adapted m-Health PN strategy A components
Más nevek:
  • Patient Navigator Program
Kísérleti: 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.
Egyéb: Best Practice
Receive EUC
Más nevek:
  • az ellátás színvonala
  • standard terápia
Egyéb: Interview - Ancillary studies
Ancillary studies
Egyéb: Survey Administration - Ancillary studies
Ancillary studies
Viselkedési: Patient Navigation - C Components
Receive adapted m-Health PN strategy C components
Más nevek:
  • Patient Navigator Program
Viselkedési: Patient Navigation - A components
Receive adapted m-Health PN strategy A components
Más nevek:
  • Patient Navigator Program
Kísérleti: 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.
Egyéb: Best Practice
Receive EUC
Más nevek:
  • az ellátás színvonala
  • standard terápia
Egyéb: Interview - Ancillary studies
Ancillary studies
Egyéb: Survey Administration - Ancillary studies
Ancillary studies
Viselkedési: Patient Navigation - B components
Receive adapted m-Health PN strategy B components
Más nevek:
  • Patient Navigator Program
Viselkedési: Patient Navigation - A components
Receive adapted m-Health PN strategy A components
Más nevek:
  • Patient Navigator Program
Kísérleti: 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.
Egyéb: Best Practice
Receive EUC
Más nevek:
  • az ellátás színvonala
  • standard terápia
Egyéb: Interview - Ancillary studies
Ancillary studies
Egyéb: Survey Administration - Ancillary studies
Ancillary studies
Viselkedési: Patient Navigation - C Components
Receive adapted m-Health PN strategy C components
Más nevek:
  • Patient Navigator Program
Viselkedési: Patient Navigation - B components
Receive adapted m-Health PN strategy B components
Más nevek:
  • Patient Navigator Program
Viselkedési: Patient Navigation - A components
Receive adapted m-Health PN strategy A components
Más nevek:
  • Patient Navigator Program

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Adapted evidence-based intervention (EBI) delivery strategies (Aim 1)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Time to MMG screening (Aim 3)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

Emory University

Együttműködők

National Cancer Institute (NCI)

Nyomozók

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

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Tényleges)

2025. július 22.

Elsődleges befejezés (Becsült)

2028. június 30.

A tanulmány befejezése (Becsült)

2029. június 30.

Tanulmányi regisztráció dátumai

Először benyújtva

2026. augusztus 10.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2026. augusztus 10.

Első közzététel (Tényleges)

2026. augusztus 14.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2026. augusztus 14.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2026. augusztus 10.

Utolsó ellenőrzés

2026. augusztus 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

További vonatkozó MeSH feltételek

Egyéb vizsgálati azonosító számok

  • STUDY00008713 (Egyéb azonosító: Emory University Hospital/Winship Cancer Institute)
  • P30CA138292 (Az Egyesült Államok NIH támogatása/szerződése)
  • U54CA284036 (Az Egyesült Államok NIH támogatása/szerződése)
  • NCI-2025-05473 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • EU6635-25 (Egyéb azonosító: Emory University Hospital/Winship Cancer Institute)

Gyógyszer- és eszközinformációk, tanulmányi dokumentumok

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Nem

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Nem

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