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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Intervention 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.
Primary Purpose
Screening
Masking
Single (Outcomes Assessor)
Masking Description
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).

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Other: Discussion
    Complete a focus group
    Other names:
    • Discuss
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.
  • Other: Interview - Stakeholder
    Complete stakeholder interview
  • Other: Survey Administration
    Complete EBI adaptation and implementation surveys
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.
  • Other: Interview - Key Informant
    Complete key informant interview
  • Other: Survey Administration
    Complete EBI adaptation and implementation surveys
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.
  • Other: Best Practice
    Receive EUC
    Other names:
    • standard of care
    • standard therapy
  • Other: Interview - Ancillary studies
    Ancillary studies
  • Other: Survey Administration - Ancillary studies
    Ancillary studies
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.
  • Other: Best Practice
    Receive EUC
    Other names:
    • standard of care
    • standard therapy
  • Other: Interview - Ancillary studies
    Ancillary studies
  • Behavioral: Patient Navigation - C Components
    Receive adapted m-Health PN strategy C components
    Other names:
    • Patient Navigator Program
  • Other: Survey Administration - Ancillary studies
    Ancillary studies
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.
  • Other: Best Practice
    Receive EUC
    Other names:
    • standard of care
    • standard therapy
  • Other: Interview - Ancillary studies
    Ancillary studies
  • Behavioral: Patient Navigation - B components
    Receive adapted m-Health PN strategy B components
    Other names:
    • Patient Navigator Program
  • Other: Survey Administration - Ancillary studies
    Ancillary studies
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.
  • Other: Best Practice
    Receive EUC
    Other names:
    • standard of care
    • standard therapy
  • Other: Interview - Ancillary studies
    Ancillary studies
  • Behavioral: Patient Navigation - C Components
    Receive adapted m-Health PN strategy C components
    Other names:
    • Patient Navigator Program
  • Behavioral: Patient Navigation - B components
    Receive adapted m-Health PN strategy B components
    Other names:
    • Patient Navigator Program
  • Other: Survey Administration - Ancillary studies
    Ancillary studies
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.
  • Other: Best Practice
    Receive EUC
    Other names:
    • standard of care
    • standard therapy
  • Other: Interview - Ancillary studies
    Ancillary studies
  • Behavioral: Patient Navigation - A components
    Receive adapted m-Health PN strategy A components
    Other names:
    • Patient Navigator Program
  • Other: Survey Administration - Ancillary studies
    Ancillary studies
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.
  • Other: Best Practice
    Receive EUC
    Other names:
    • standard of care
    • standard therapy
  • Other: Interview - Ancillary studies
    Ancillary studies
  • Behavioral: Patient Navigation - C Components
    Receive adapted m-Health PN strategy C components
    Other names:
    • Patient Navigator Program
  • Behavioral: Patient Navigation - A components
    Receive adapted m-Health PN strategy A components
    Other names:
    • Patient Navigator Program
  • Other: Survey Administration - Ancillary studies
    Ancillary studies
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.
  • Other: Best Practice
    Receive EUC
    Other names:
    • standard of care
    • standard therapy
  • Other: Interview - Ancillary studies
    Ancillary studies
  • Behavioral: Patient Navigation - B components
    Receive adapted m-Health PN strategy B components
    Other names:
    • Patient Navigator Program
  • Behavioral: Patient Navigation - A components
    Receive adapted m-Health PN strategy A components
    Other names:
    • Patient Navigator Program
  • Other: Survey Administration - Ancillary studies
    Ancillary studies
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.
  • Other: Best Practice
    Receive EUC
    Other names:
    • standard of care
    • standard therapy
  • Other: Interview - Ancillary studies
    Ancillary studies
  • Behavioral: Patient Navigation - C Components
    Receive adapted m-Health PN strategy C components
    Other names:
    • Patient Navigator Program
  • Behavioral: Patient Navigation - B components
    Receive adapted m-Health PN strategy B components
    Other names:
    • Patient Navigator Program
  • Behavioral: Patient Navigation - A components
    Receive adapted m-Health PN strategy A components
    Other names:
    • Patient Navigator Program
  • Other: Survey Administration - Ancillary studies
    Ancillary studies

Recruiting Locations

Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia 30322
Contact:
Michael Chung
404-251-4012
michael.h.chung@emory.edu

More Details

Status
Recruiting
Sponsor
Emory University

Study Contact

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.