Mobile Health Patient Navigation for the Improvement of Screening and the Early Detection of Breast Cancer in Women Accessing Primary Care Clinics in Kenya
2026年8月10日 更新者：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.
研究概览
地位
招聘中
条件
干预/治疗
- 其他：Discussion
- 其他：Interview - Stakeholder
- 其他：Survey Administration
- 其他：Interview - Key Informant
- 其他：Best Practice
- 其他：Interview - Ancillary studies
- 其他：Survey Administration - Ancillary studies
- 行为的：Patient Navigation - C Components
- 行为的：Patient Navigation - B components
- 行为的：Patient Navigation - A components
详细说明
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.
研究类型
介入性
注册 (估计的)
800
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Georgia
-
Atlanta、Georgia、美国、30322
- 招聘中
- Emory University Hospital/Winship Cancer Institute
-
首席研究员：
- Michael Chung
-
接触：
- Michael Chung
- 电话号码：404-251-4012
- 邮箱：michael.h.chung@emory.edu
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
是的
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：放映
- 分配：随机化
- 介入模型：顺序分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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
其他名称：
|
|
实验性的：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
|
|
实验性的：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
|
|
有源比较器：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
其他名称：
Ancillary studies
Ancillary studies
|
|
实验性的：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
其他名称：
Ancillary studies
Ancillary studies
Receive adapted m-Health PN strategy C components
其他名称：
|
|
实验性的：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
其他名称：
Ancillary studies
Ancillary studies
Receive adapted m-Health PN strategy B components
其他名称：
|
|
实验性的：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
其他名称：
Ancillary studies
Ancillary studies
Receive adapted m-Health PN strategy C components
其他名称：
Receive adapted m-Health PN strategy B components
其他名称：
|
|
实验性的：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
其他名称：
Ancillary studies
Ancillary studies
Receive adapted m-Health PN strategy A components
其他名称：
|
|
实验性的：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
其他名称：
Ancillary studies
Ancillary studies
Receive adapted m-Health PN strategy C components
其他名称：
Receive adapted m-Health PN strategy A components
其他名称：
|
|
实验性的：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
其他名称：
Ancillary studies
Ancillary studies
Receive adapted m-Health PN strategy B components
其他名称：
Receive adapted m-Health PN strategy A components
其他名称：
|
|
实验性的：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
其他名称：
Ancillary studies
Ancillary studies
Receive adapted m-Health PN strategy C components
其他名称：
Receive adapted m-Health PN strategy B components
其他名称：
Receive adapted m-Health PN strategy A components
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Adapted evidence-based intervention (EBI) delivery strategies (Aim 1)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Time to MMG screening (Aim 3)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Michael Chung、Emory University Hospital/Winship Cancer Institute
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2025年7月22日
初级完成 (估计的)
2028年6月30日
研究完成 (估计的)
2029年6月30日
研究注册日期
首次提交
2026年8月10日
首先提交符合 QC 标准的
2026年8月10日
首次发布 (实际的)
2026年8月14日
研究记录更新
最后更新发布 (实际的)
2026年8月14日
上次提交的符合 QC 标准的更新
2026年8月10日
最后验证
2026年8月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- STUDY00008713 (其他标识符：Emory University Hospital/Winship Cancer Institute)
- P30CA138292 (美国 NIH 拨款/合同)
- U54CA284036 (美国 NIH 拨款/合同)
- NCI-2025-05473 (注册表标识符：CTRP (Clinical Trial Reporting Program))
- EU6635-25 (其他标识符：Emory University Hospital/Winship Cancer Institute)
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.