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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Enrollment
800
Receive EUC
Complete a focus group
Complete stakeholder interview
Complete key informant interview
Ancillary studies
Receive adapted m-Health PN strategy C components
Receive adapted m-Health PN strategy B components
Receive adapted m-Health PN strategy A components
Complete EBI adaptation and implementation surveys
Ancillary studies
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
RECRUITINGAdapted 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.
Time frame: 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.
Time frame: 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).
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)
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).
Time frame: Up to 6 months
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
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Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Up to 2 years