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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07764796.
Locations matching your search criteria
United States
Georgia
Atlanta
Emory University Hospital/Winship Cancer InstituteStatus: Active
Contact: Michael Chung
Phone: 404-251-4012
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.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationEmory University Hospital/Winship Cancer Institute
Principal InvestigatorMichael Chung
