Recruiting

m-Health PN

Sponsor:

Emory University

Code:

NCT07764796

Conditions

Breast Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Best Practice

Discussion

Interview - Stakeholder

Interview - Key Informant

Interview - Ancillary studies

Study Details

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

Study ID

NCT07764796

Start date

Jul 22, 2025

Status verified date

Aug, 2026

Completion date

Jun 30, 2029

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

800 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: Aim 1 (focus group)

Participants complete a focus group over 60-90 minutes in support of the identification and selection of EBIs on study.

experimental: Aim 2 group I (stakeholder interview, surveys)

Participants complete a stakeholder interview and complete surveys to further inform EBI adaptation and implementation on study.

experimental: 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.

active comparator: 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.

experimental: 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.

experimental: 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.

experimental: 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.

experimental: 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.

experimental: 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.

experimental: 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.

experimental: 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.

Interventions

Best Practice

Receive EUC

Discussion

Complete a focus group

Interview - Stakeholder

Complete stakeholder interview

Interview - Key Informant

Complete key informant interview

Interview - Ancillary studies

Ancillary studies

Patient Navigation - C Components

Receive adapted m-Health PN strategy C components

Patient Navigation - B components

Receive adapted m-Health PN strategy B components

Patient Navigation - A components

Receive adapted m-Health PN strategy A components

Survey Administration

Complete EBI adaptation and implementation surveys

Survey Administration - Ancillary studies

Ancillary studies

Primary outcome measure

  • Adapted evidence-based intervention (EBI) delivery strategies (Aim 1) [ Time Frame: Up to 2 years ]
  • Health system resources, training, and requirements for EBI implementation (Aim 2) [ Time Frame: Up to 4 years ]
  • Access to screening mammography (MMG) for eligible asymptomatic women (Aim 3) [ Time Frame: 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) [ Time Frame: Up to 6 months ]

Central Contacts and Locations

Locations

Emory University Hospital/Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Michael Chung

404-251-4012michael.h.chung@emory.edu

Principal Investigator:

Michael Chung

More Information

Sponsor

Emory University

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-08-14.