Breast CarcinomaNCT07764796
Mobile Health Patient Navigation for the Improvement of Screening and the Early Detection of Breast Cancer in Women Accessing Primary Care Clinics in Kenya
A study testing Best Practice, Discussion and Interview - Stakeholder in people with Breast Carcinoma, run by Emory University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Carcinoma
- What is being tested?
- Best Practice, Discussion and Interview - Stakeholder
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2025to 30 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Michael Chung, 404-251-4012, michael.h.chung@emory.edu
Michael Chung
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Breast Carcinoma
- Being tested
- Best Practice, Discussion, Interview - Stakeholder, Interview - Key Informant, Interview - Ancillary studies
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive EUC
DiscussionOther
Also called Discuss
Complete a focus group
Interview - StakeholderOther
Complete stakeholder interview
Interview - Key InformantOther
Complete key informant interview
Interview - Ancillary studiesOther
Ancillary studies
Patient Navigation - C ComponentsBehavioural
Also called Patient Navigator Program
Receive adapted m-Health PN strategy C components
Patient Navigation - B componentsBehavioural
Also called Patient Navigator Program
Receive adapted m-Health PN strategy B components
Patient Navigation - A componentsBehavioural
Also called Patient Navigator Program
Receive adapted m-Health PN strategy A components
Survey AdministrationOther
Complete EBI adaptation and implementation surveys
Survey Administration - Ancillary studiesOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Aim 1 (focus group) | Experimental | Participants complete a focus group over 60-90 minutes in support of the identification and selection of EBIs on study. Receives: Other: Discussion |
| Aim 2 group I (stakeholder interview, surveys) | Experimental | Participants complete a stakeholder interview and complete surveys to further inform EBI adaptation and implementation on study. Receives: Other: Interview - Stakeholder; Other: Survey Administration |
| Aim 2 group II (key informant interview, surveys) | Experimental | Participants complete a key informant interview and complete surveys to further inform EBI adaptation and implementation on study. Receives: Other: Interview - Key Informant; Other: Survey Administration |
| Aim 3 arm 1 (EUC) | Active comparator | 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. Receives: Other: Best Practice; Other: Interview - Ancillary studies; Other: Survey Administration - Ancillary studies |
| Aim 3 arm 2 (EUC, PN strategy C) | Experimental | Patients receive EUC as in arm I and adapted m-Health PN strategy C components on study. Receives: Other: Best Practice; Other: Interview - Ancillary studies; Behavioral: Patient Navigation - C Components; Other: Survey Administration - Ancillary studies |
| Aim 3 arm 3 (EUC, PN strategy B) | Experimental | Patients receive EUC as in arm I and adapted m-Health PN strategy B components on study. Receives: Other: Best Practice; Other: Interview - Ancillary studies; Behavioral: Patient Navigation - B components; Other: Survey Administration - Ancillary studies |
| Aim 3 arm 4 (EUC, PN strategy B and C) | Experimental | Patients receive EUC as in arm I and adapted m-Health PN strategy B and C components on study. Receives: Other: Best Practice; Other: Interview - Ancillary studies; Behavioral: Patient Navigation - C Components; Behavioral: Patient Navigation - B components; Other: Survey Administration - Ancillary studies |
| Aim 3 arm 5 (EUC, PN strategy A) | Experimental | Patients receive EUC as in arm I and adapted m-Health PN strategy A components on study. Receives: Other: Best Practice; Other: Interview - Ancillary studies; Behavioral: Patient Navigation - A components; Other: Survey Administration - Ancillary studies |
| Aim 3 arm 6 (EUC, PN strategy A and C) | Experimental | Patients receive EUC as in arm I and adapted m-Health PN strategy A and C components on study. Receives: Other: Best Practice; Other: Interview - Ancillary studies; Behavioral: Patient Navigation - C Components; Behavioral: Patient Navigation - A components; Other: Survey Administration - Ancillary studies |
| Aim 3 arm 7 (EUC, PN strategy A and B) | Experimental | Patients receive EUC as in arm I and adapted m-Health PN strategy A and B components on study. Receives: Other: Best Practice; Other: Interview - Ancillary studies; Behavioral: Patient Navigation - B components; Behavioral: Patient Navigation - A components; Other: Survey Administration - Ancillary studies |
| Aim 3 arm 8 (EUC, PN strategy A, B, and C) | Experimental | Patients receive EUC as in arm I and adapted m-Health PN strategy A, B, and C components on study. Receives: Other: Best Practice; Other: Interview - Ancillary studies; Behavioral: Patient Navigation - C Components; Behavioral: Patient Navigation - B components; Behavioral: Patient Navigation - A components; Other: Survey Administration - Ancillary studies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adapted evidence-based intervention (EBI) delivery strategies (Aim 1)
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.
Measured: Up to 2 years
Health system resources, training, and requirements for EBI implementation (Aim 2)
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.
Measured: Up to 4 years
Access to screening mammography (MMG) for eligible asymptomatic women (Aim 3)
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).
Measured: 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)
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).
Measured: Up to 6 months
Secondary outcomes (7)
Time to MMG screening (Aim 3)
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).
Measured: Up to 2 years
Time to diagnostic MMG (Aim 3)
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).
Measured: Up to 2 years
Time to breast ultrasound (Aim 3)
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).
Measured: Up to 2 years
Time to breast biopsy (if required) (Aim 3)
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).
Measured: Up to 2 years
Time to participant receipt of screening MMG result (Aim 3)
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).
Measured: Up to 2 years
Time to receipt of ultrasound and/or biopsy result (Aim 3)
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).
Measured: Up to 2 years
Proportion of participants who receive access to the entire (or partial) screening and diagnosis care pathway (Aim 3)
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).
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start22 Jul 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Will use a Multi-phase Optimization Strategy to select, pilot test, and then evaluate, through an efficient 2X2X2 factorial trial design, a package of evidence-based interventions.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Michael H Chung, Emory University
- Investigators
- Michael Chung, Principal investigator, Emory University Hospital/Winship Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07764796
- Sponsor's protocol ID
- STUDY00008713
- Other IDs
- NCI-2025-05473, STUDY00008713, EU6635-25, P30CA138292, U54CA284036
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07764796
- Acronym / sponsor ID
- STUDY00008713
- Conditions
- Breast Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 22 Jul 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 14 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 11
- Model description
- Will use a Multi-phase Optimization Strategy to select, pilot test, and then evaluate, through an efficient 2X2X2 factorial trial design, a package of evidence-based interventions.
| Arm | Type | Receives |
|---|---|---|
| Aim 1 (focus group) | Experimental | Other: DiscussionParticipants complete a focus group over 60-90 minutes in support of the identification and selection of EBIs on study. |
| Aim 2 group I (stakeholder interview, surveys) | Experimental | Other: Interview - Stakeholder, Other: Survey AdministrationParticipants complete a stakeholder interview and complete surveys to further inform EBI adaptation and implementation on study. |
| Aim 2 group II (key informant interview, surveys) | Experimental | Other: Interview - Key Informant, Other: Survey AdministrationParticipants complete a key informant interview and complete surveys to further inform EBI adaptation and implementation on study. |
| Aim 3 arm 1 (EUC) | Active comparator | Other: Best Practice, Other: Interview - Ancillary studies, Other: Survey Administration - Ancillary studiesPatients 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. |
| Aim 3 arm 2 (EUC, PN strategy C) | Experimental | Other: Best Practice, Other: Interview - Ancillary studies, Behavioral: Patient Navigation - C Components, Other: Survey Administration - Ancillary studiesPatients receive EUC as in arm I and adapted m-Health PN strategy C components on study. |
| Aim 3 arm 3 (EUC, PN strategy B) | Experimental | Other: Best Practice, Other: Interview - Ancillary studies, Behavioral: Patient Navigation - B components, Other: Survey Administration - Ancillary studiesPatients receive EUC as in arm I and adapted m-Health PN strategy B components on study. |
| Aim 3 arm 4 (EUC, PN strategy B and C) | Experimental | Other: Best Practice, Other: Interview - Ancillary studies, Behavioral: Patient Navigation - C Components, Behavioral: Patient Navigation - B components, Other: Survey Administration - Ancillary studiesPatients receive EUC as in arm I and adapted m-Health PN strategy B and C components on study. |
| Aim 3 arm 5 (EUC, PN strategy A) | Experimental | Other: Best Practice, Other: Interview - Ancillary studies, Behavioral: Patient Navigation - A components, Other: Survey Administration - Ancillary studiesPatients receive EUC as in arm I and adapted m-Health PN strategy A components on study. |
| Aim 3 arm 6 (EUC, PN strategy A and C) | Experimental | Other: Best Practice, Other: Interview - Ancillary studies, Behavioral: Patient Navigation - C Components, Behavioral: Patient Navigation - A components, Other: Survey Administration - Ancillary studiesPatients receive EUC as in arm I and adapted m-Health PN strategy A and C components on study. |
| Aim 3 arm 7 (EUC, PN strategy A and B) | Experimental | Other: Best Practice, Other: Interview - Ancillary studies, Behavioral: Patient Navigation - B components, Behavioral: Patient Navigation - A components, Other: Survey Administration - Ancillary studiesPatients receive EUC as in arm I and adapted m-Health PN strategy A and B components on study. |
| Aim 3 arm 8 (EUC, PN strategy A, B, and C) | Experimental | Other: Best Practice, Other: Interview - Ancillary studies, Behavioral: Patient Navigation - C Components, Behavioral: Patient Navigation - B components, Behavioral: Patient Navigation - A components, Other: Survey Administration - Ancillary studiesPatients receive EUC as in arm I and adapted m-Health PN strategy A, B, and C components on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive EUC | Other | Aim 3 arm 1 (EUC), Aim 3 arm 2 (EUC, PN strategy C), Aim 3 arm 3 (EUC, PN strategy B), Aim 3 arm 4 (EUC, PN strategy B and C), Aim 3 arm 5 (EUC, PN strategy A), Aim 3 arm 6 (EUC, PN strategy A and C), Aim 3 arm 7 (EUC, PN strategy A and B), Aim 3 arm 8 (EUC, PN strategy A, B, and C) |
| DiscussionAlso: DiscussComplete a focus group | Other | Aim 1 (focus group) |
| Interview - StakeholderComplete stakeholder interview | Other | Aim 2 group I (stakeholder interview, surveys) |
| Interview - Key InformantComplete key informant interview | Other | Aim 2 group II (key informant interview, surveys) |
| Interview - Ancillary studiesAncillary studies | Other | Aim 3 arm 1 (EUC), Aim 3 arm 2 (EUC, PN strategy C), Aim 3 arm 3 (EUC, PN strategy B), Aim 3 arm 4 (EUC, PN strategy B and C), Aim 3 arm 5 (EUC, PN strategy A), Aim 3 arm 6 (EUC, PN strategy A and C), Aim 3 arm 7 (EUC, PN strategy A and B), Aim 3 arm 8 (EUC, PN strategy A, B, and C) |
| Patient Navigation - C ComponentsAlso: Patient Navigator ProgramReceive adapted m-Health PN strategy C components | Behavioural | Aim 3 arm 2 (EUC, PN strategy C), Aim 3 arm 4 (EUC, PN strategy B and C), Aim 3 arm 6 (EUC, PN strategy A and C), Aim 3 arm 8 (EUC, PN strategy A, B, and C) |
| Patient Navigation - B componentsAlso: Patient Navigator ProgramReceive adapted m-Health PN strategy B components | Behavioural | Aim 3 arm 3 (EUC, PN strategy B), Aim 3 arm 4 (EUC, PN strategy B and C), Aim 3 arm 7 (EUC, PN strategy A and B), Aim 3 arm 8 (EUC, PN strategy A, B, and C) |
| Patient Navigation - A componentsAlso: Patient Navigator ProgramReceive adapted m-Health PN strategy A components | Behavioural | Aim 3 arm 5 (EUC, PN strategy A), Aim 3 arm 6 (EUC, PN strategy A and C), Aim 3 arm 7 (EUC, PN strategy A and B), Aim 3 arm 8 (EUC, PN strategy A, B, and C) |
| Survey AdministrationComplete EBI adaptation and implementation surveys | Other | Aim 2 group I (stakeholder interview, surveys), Aim 2 group II (key informant interview, surveys) |
| Survey Administration - Ancillary studiesAncillary studies | Other | Aim 3 arm 1 (EUC), Aim 3 arm 2 (EUC, PN strategy C), Aim 3 arm 3 (EUC, PN strategy B), Aim 3 arm 4 (EUC, PN strategy B and C), Aim 3 arm 5 (EUC, PN strategy A), Aim 3 arm 6 (EUC, PN strategy A and C), Aim 3 arm 7 (EUC, PN strategy A and B), Aim 3 arm 8 (EUC, PN strategy A, B, and C) |
Primary outcome
Adapted evidence-based intervention (EBI) delivery strategies (Aim 1)
Time frame: 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.
Health system resources, training, and requirements for EBI implementation (Aim 2)
Time frame: 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.
Access to screening mammography (MMG) for eligible asymptomatic women (Aim 3)
Time frame: 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).
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)
Time frame: 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).
7 secondary outcomes
Time to MMG screening (Aim 3)
Time frame: Up to 2 years
Time to diagnostic MMG (Aim 3)
Time frame: Up to 2 years
Time to breast ultrasound (Aim 3)
Time frame: Up to 2 years
Time to breast biopsy (if required) (Aim 3)
Time frame: Up to 2 years
Time to participant receipt of screening MMG result (Aim 3)
Time frame: Up to 2 years
Time to receipt of ultrasound and/or biopsy result (Aim 3)
Time frame: Up to 2 years
Proportion of participants who receive access to the entire (or partial) screening and diagnosis care pathway (Aim 3)
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emory University Hospital/Winship Cancer Institute
Atlanta, United States
Michael Chung principal investigator
Emory University Hospital/Winship Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, Discussion and Interview - Stakeholder in people with Breast Carcinoma, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adapted evidence-based intervention (EBI) delivery strategies (Aim 1) (time frame: Up to 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.