Mobile Health Patient Navigation for the Improvement of Screening and the Early Detection of Breast Cancer in Women Accessing Primary Care Clinics in Kenya

NCT07764796 | Recruiting

• 5 other identifiers: STUDY00008713NCI-2025-05473EU6635-25P30CA138292U54CA284036
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Breast Carcinoma

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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).

  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).

  Up to 6 months

Secondary Outcomes (7)

• Time to MMG screening (Aim 3)

  Up to 2 years

• Time to diagnostic MMG (Aim 3)

  Up to 2 years

• Time to breast ultrasound (Aim 3)

  Up to 2 years

• Time to breast biopsy (if required) (Aim 3)

  Up to 2 years

• Time to participant receipt of screening MMG result (Aim 3)

  Up to 2 years

Study Arms (11)

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

Interventions

Best Practice OTHER

Receive EUC

Also known as: standard of care, standard therapy

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)

Discussion OTHER

Complete a focus group

Also known as: Discuss

Aim 1 (focus group)

Interview - Stakeholder OTHER

Complete stakeholder interview

Aim 2 group I (stakeholder interview, surveys)

Interview - Key Informant OTHER

Complete key informant interview

Aim 2 group II (key informant interview, surveys)

Interview - Ancillary studies OTHER

Ancillary studies

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 Components BEHAVIORAL

Receive adapted m-Health PN strategy C components

Also known as: Patient Navigator Program

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 components BEHAVIORAL

Receive adapted m-Health PN strategy B components

Also known as: Patient Navigator Program

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 components BEHAVIORAL

Receive adapted m-Health PN strategy A components

Also known as: Patient Navigator Program

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 Administration OTHER

Complete EBI adaptation and implementation surveys

Aim 2 group I (stakeholder interview, surveys); Aim 2 group II (key informant interview, surveys)

Survey Administration - Ancillary studies OTHER

Ancillary studies

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Practice Guidelines as Topic; Standard of Care; Patient Navigation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management

Study Officials

• Michael Chung

  Emory University Hospital/Winship Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: We 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).
• Purpose: SCREENING
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: August 14, 2026
• Study Start: July 22, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: August 14, 2026

Record last verified: 2026-08

Locations

US (1)