Mobile Health Patient Navigation for the Improvement of Screening and the Early Detection of Breast Cancer in Women Accessing Primary Care Clinics in Kenya
2026년 8월 10일 업데이트: Michael H Chung, Emory University
A Multi-Level Strategy for Integrating Information Technology and Mobile Health to Strengthen Linkages to Breast Cancer Screening and Early Detection Among Women Utilizing Primary Care in Kenya (MATITI YANGU)
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.
연구 개요
상태
모병
정황
개입 / 치료
- 다른: Discussion
- 다른: Interview - Stakeholder
- 다른: Survey Administration
- 다른: Interview - Key Informant
- 다른: Best Practice
- 다른: Interview - Ancillary studies
- 다른: Survey Administration - Ancillary studies
- 행동: Patient Navigation - C Components
- 행동: Patient Navigation - B components
- 행동: Patient Navigation - A components
상세 설명
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.
연구 유형
중재적
등록 (추정된)
800
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
Georgia
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Atlanta, Georgia, 미국, 30322
- 모병
- Emory University Hospital/Winship Cancer Institute
-
수석 연구원:
- Michael Chung
-
연락하다:
- Michael Chung
- 전화번호: 404-251-4012
- 이메일: michael.h.chung@emory.edu
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 상영
- 할당: 무작위
- 중재 모델: 순차적 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Aim 1 (focus group)
Participants complete a focus group over 60-90 minutes in support of the identification and selection of EBIs on study.
|
Complete a focus group
다른 이름들:
|
|
실험적: Aim 2 group I (stakeholder interview, surveys)
Participants complete a stakeholder interview and complete surveys to further inform EBI adaptation and implementation on study.
|
Complete stakeholder interview
Complete EBI adaptation and implementation surveys
|
|
실험적: 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.
|
Complete EBI adaptation and implementation surveys
Complete key informant interview
|
|
활성 비교기: 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.
|
Receive EUC
다른 이름들:
Ancillary studies
Ancillary studies
|
|
실험적: 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.
|
Receive EUC
다른 이름들:
Ancillary studies
Ancillary studies
Receive adapted m-Health PN strategy C components
다른 이름들:
|
|
실험적: 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.
|
Receive EUC
다른 이름들:
Ancillary studies
Ancillary studies
Receive adapted m-Health PN strategy B components
다른 이름들:
|
|
실험적: 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.
|
Receive EUC
다른 이름들:
Ancillary studies
Ancillary studies
Receive adapted m-Health PN strategy C components
다른 이름들:
Receive adapted m-Health PN strategy B components
다른 이름들:
|
|
실험적: 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.
|
Receive EUC
다른 이름들:
Ancillary studies
Ancillary studies
Receive adapted m-Health PN strategy A components
다른 이름들:
|
|
실험적: 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.
|
Receive EUC
다른 이름들:
Ancillary studies
Ancillary studies
Receive adapted m-Health PN strategy C components
다른 이름들:
Receive adapted m-Health PN strategy A components
다른 이름들:
|
|
실험적: 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.
|
Receive EUC
다른 이름들:
Ancillary studies
Ancillary studies
Receive adapted m-Health PN strategy B components
다른 이름들:
Receive adapted m-Health PN strategy A components
다른 이름들:
|
|
실험적: 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.
|
Receive EUC
다른 이름들:
Ancillary studies
Ancillary studies
Receive adapted m-Health PN strategy C components
다른 이름들:
Receive adapted m-Health PN strategy B components
다른 이름들:
Receive adapted m-Health PN strategy A components
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Adapted evidence-based intervention (EBI) delivery strategies (Aim 1)
기간: Up to 2 years
|
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)
기간: Up to 4 years
|
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)
기간: Up to 6 months
|
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)
기간: Up to 6 months
|
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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Time to MMG screening (Aim 3)
기간: Up to 2 years
|
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 2 years
|
|
Time to diagnostic MMG (Aim 3)
기간: Up to 2 years
|
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 2 years
|
|
Time to breast ultrasound (Aim 3)
기간: Up to 2 years
|
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 2 years
|
|
Time to breast biopsy (if required) (Aim 3)
기간: Up to 2 years
|
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 2 years
|
|
Time to participant receipt of screening MMG result (Aim 3)
기간: Up to 2 years
|
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 2 years
|
|
Time to receipt of ultrasound and/or biopsy result (Aim 3)
기간: Up to 2 years
|
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 2 years
|
|
Proportion of participants who receive access to the entire (or partial) screening and diagnosis care pathway (Aim 3)
기간: Up to 2 years
|
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 2 years
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 수석 연구원: Michael Chung, Emory University Hospital/Winship Cancer Institute
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2025년 7월 22일
기본 완료 (추정된)
2028년 6월 30일
연구 완료 (추정된)
2029년 6월 30일
연구 등록 날짜
최초 제출
2026년 8월 10일
QC 기준을 충족하는 최초 제출
2026년 8월 10일
처음 게시됨 (실제)
2026년 8월 14일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 14일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 10일
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- STUDY00008713 (기타 식별자: Emory University Hospital/Winship Cancer Institute)
- P30CA138292 (미국 NIH 보조금/계약)
- U54CA284036 (미국 NIH 보조금/계약)
- NCI-2025-05473 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
- EU6635-25 (기타 식별자: Emory University Hospital/Winship Cancer Institute)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .