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 augusti 2026 uppdaterad av: 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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
- Övrig: Discussion
- Övrig: Interview - Stakeholder
- Övrig: Survey Administration
- Övrig: Interview - Key Informant
- Övrig: Best Practice
- Övrig: Interview - Ancillary studies
- Övrig: Survey Administration - Ancillary studies
- Beteende: Patient Navigation - C Components
- Beteende: Patient Navigation - B components
- Beteende: Patient Navigation - A components
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
800
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Georgia
-
Atlanta, Georgia, Förenta staterna, 30322
- Rekrytering
- Emory University Hospital/Winship Cancer Institute
-
Huvudutredare:
- Michael Chung
-
Kontakt:
- Michael Chung
- Telefonnummer: 404-251-4012
- E-post: michael.h.chung@emory.edu
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Ja
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Undersökning
- Tilldelning: Randomiserad
- Interventionsmodell: Sekventiell tilldelning
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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
Andra namn:
|
|
Experimentell: 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
|
|
Experimentell: 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
|
|
Aktiv 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.
|
Receive EUC
Andra namn:
Ancillary studies
Ancillary studies
|
|
Experimentell: 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
Andra namn:
Ancillary studies
Ancillary studies
Receive adapted m-Health PN strategy C components
Andra namn:
|
|
Experimentell: 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
Andra namn:
Ancillary studies
Ancillary studies
Receive adapted m-Health PN strategy B components
Andra namn:
|
|
Experimentell: 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
Andra namn:
Ancillary studies
Ancillary studies
Receive adapted m-Health PN strategy C components
Andra namn:
Receive adapted m-Health PN strategy B components
Andra namn:
|
|
Experimentell: 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
Andra namn:
Ancillary studies
Ancillary studies
Receive adapted m-Health PN strategy A components
Andra namn:
|
|
Experimentell: 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
Andra namn:
Ancillary studies
Ancillary studies
Receive adapted m-Health PN strategy C components
Andra namn:
Receive adapted m-Health PN strategy A components
Andra namn:
|
|
Experimentell: 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
Andra namn:
Ancillary studies
Ancillary studies
Receive adapted m-Health PN strategy B components
Andra namn:
Receive adapted m-Health PN strategy A components
Andra namn:
|
|
Experimentell: 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
Andra namn:
Ancillary studies
Ancillary studies
Receive adapted m-Health PN strategy C components
Andra namn:
Receive adapted m-Health PN strategy B components
Andra namn:
Receive adapted m-Health PN strategy A components
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Adapted evidence-based intervention (EBI) delivery strategies (Aim 1)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Time to MMG screening (Aim 3)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Michael Chung, Emory University Hospital/Winship Cancer Institute
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
22 juli 2025
Primärt slutförande (Beräknad)
30 juni 2028
Avslutad studie (Beräknad)
30 juni 2029
Studieregistreringsdatum
Först inskickad
10 augusti 2026
Först inskickad som uppfyllde QC-kriterierna
10 augusti 2026
Första postat (Faktisk)
14 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
14 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
10 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Neoplasmer efter plats
- Neoplasmer
- Hudsjukdomar
- Bröstsjukdomar
- Hud- och bindvävssjukdomar
- Bröstneoplasmer
- Administration
- Sjukvårdskvalitet, tillgång och utvärdering
- Hälsovårdskvalitet
- Kvalitetsindikatorer, hälsovård
- Riktlinjer som ämne
- Kvalitetssäkring, hälsovård
- Patientvårdshantering
- Omfattande vård
- Patientcentrerad vård
- Grundvård
- Vårdstandard
- Öva riktlinjer som ämne
- Patientnavigering
Andra studie-ID-nummer
- STUDY00008713 (Annan identifierare: Emory University Hospital/Winship Cancer Institute)
- P30CA138292 (U.S.S. NIH-anslag/kontrakt)
- U54CA284036 (U.S.S. NIH-anslag/kontrakt)
- NCI-2025-05473 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
- EU6635-25 (Annan identifierare: Emory University Hospital/Winship Cancer Institute)
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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