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Mobile Health Patient Navigation for the Improvement of Screening and the Early Detection of Breast Cancer in Women Accessing Primary Care Clinics in Kenya

10 августа 2026 г. обновлено: 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.

Обзор исследования

Статус

Рекрутинг

Условия

Вмешательство/лечение

Подробное описание

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.

Тип исследования

Интервенционный

Регистрация (Оцененный)

800

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

  • Соединенные Штаты
    • Georgia
      • Atlanta, Georgia, Соединенные Штаты, 30322
        • Рекрутинг
        • Emory University Hospital/Winship Cancer Institute
        • Главный следователь:
          • Michael Chung
        • Контакт:

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Да

Описание

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

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Скрининг
  • Распределение: Рандомизированный
  • Интервенционная модель: Последовательное назначение
  • Маскировка: Одинокий

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: Aim 1 (focus group)
Participants complete a focus group over 60-90 minutes in support of the identification and selection of EBIs on study.
Другой: Discussion
Complete a focus group
Другие имена:
  • Обсуждать
Экспериментальный: Aim 2 group I (stakeholder interview, surveys)
Participants complete a stakeholder interview and complete surveys to further inform EBI adaptation and implementation on study.
Другой: Interview - Stakeholder
Complete stakeholder interview
Другой: Survey Administration
Complete EBI adaptation and implementation surveys
Экспериментальный: 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.
Другой: Survey Administration
Complete EBI adaptation and implementation surveys
Другой: Interview - Key Informant
Complete key informant interview
Активный компаратор: 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.
Другой: Best Practice
Receive EUC
Другие имена:
  • стандарт заботы
  • стандартная терапия
Другой: Interview - Ancillary studies
Ancillary studies
Другой: Survey Administration - Ancillary studies
Ancillary studies
Экспериментальный: 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.
Другой: Best Practice
Receive EUC
Другие имена:
  • стандарт заботы
  • стандартная терапия
Другой: Interview - Ancillary studies
Ancillary studies
Другой: Survey Administration - Ancillary studies
Ancillary studies
Поведенческий: Patient Navigation - C Components
Receive adapted m-Health PN strategy C components
Другие имена:
  • Программа «Навигатор пациента»
Экспериментальный: 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.
Другой: Best Practice
Receive EUC
Другие имена:
  • стандарт заботы
  • стандартная терапия
Другой: Interview - Ancillary studies
Ancillary studies
Другой: Survey Administration - Ancillary studies
Ancillary studies
Поведенческий: Patient Navigation - B components
Receive adapted m-Health PN strategy B components
Другие имена:
  • Программа «Навигатор пациента»
Экспериментальный: 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.
Другой: Best Practice
Receive EUC
Другие имена:
  • стандарт заботы
  • стандартная терапия
Другой: Interview - Ancillary studies
Ancillary studies
Другой: Survey Administration - Ancillary studies
Ancillary studies
Поведенческий: Patient Navigation - C Components
Receive adapted m-Health PN strategy C components
Другие имена:
  • Программа «Навигатор пациента»
Поведенческий: Patient Navigation - B components
Receive adapted m-Health PN strategy B components
Другие имена:
  • Программа «Навигатор пациента»
Экспериментальный: 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.
Другой: Best Practice
Receive EUC
Другие имена:
  • стандарт заботы
  • стандартная терапия
Другой: Interview - Ancillary studies
Ancillary studies
Другой: Survey Administration - Ancillary studies
Ancillary studies
Поведенческий: Patient Navigation - A components
Receive adapted m-Health PN strategy A components
Другие имена:
  • Программа «Навигатор пациента»
Экспериментальный: 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.
Другой: Best Practice
Receive EUC
Другие имена:
  • стандарт заботы
  • стандартная терапия
Другой: Interview - Ancillary studies
Ancillary studies
Другой: Survey Administration - Ancillary studies
Ancillary studies
Поведенческий: Patient Navigation - C Components
Receive adapted m-Health PN strategy C components
Другие имена:
  • Программа «Навигатор пациента»
Поведенческий: Patient Navigation - A components
Receive adapted m-Health PN strategy A components
Другие имена:
  • Программа «Навигатор пациента»
Экспериментальный: 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.
Другой: Best Practice
Receive EUC
Другие имена:
  • стандарт заботы
  • стандартная терапия
Другой: Interview - Ancillary studies
Ancillary studies
Другой: Survey Administration - Ancillary studies
Ancillary studies
Поведенческий: Patient Navigation - B components
Receive adapted m-Health PN strategy B components
Другие имена:
  • Программа «Навигатор пациента»
Поведенческий: Patient Navigation - A components
Receive adapted m-Health PN strategy A components
Другие имена:
  • Программа «Навигатор пациента»
Экспериментальный: 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.
Другой: Best Practice
Receive EUC
Другие имена:
  • стандарт заботы
  • стандартная терапия
Другой: Interview - Ancillary studies
Ancillary studies
Другой: Survey Administration - Ancillary studies
Ancillary studies
Поведенческий: Patient Navigation - C Components
Receive adapted m-Health PN strategy C components
Другие имена:
  • Программа «Навигатор пациента»
Поведенческий: Patient Navigation - B components
Receive adapted m-Health PN strategy B components
Другие имена:
  • Программа «Навигатор пациента»
Поведенческий: Patient Navigation - A components
Receive adapted m-Health PN strategy A components
Другие имена:
  • Программа «Навигатор пациента»

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Adapted evidence-based intervention (EBI) delivery strategies (Aim 1)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Time to MMG screening (Aim 3)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Emory University

Соавторы

National Cancer Institute (NCI)

Следователи

  • Главный следователь: Michael Chung, Emory University Hospital/Winship Cancer Institute

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

22 июля 2025 г.

Первичное завершение (Оцененный)

30 июня 2028 г.

Завершение исследования (Оцененный)

30 июня 2029 г.

Даты регистрации исследования

Первый отправленный

10 августа 2026 г.

Впервые представлено, что соответствует критериям контроля качества

10 августа 2026 г.

Первый опубликованный (Действительный)

14 августа 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

14 августа 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

10 августа 2026 г.

Последняя проверка

1 августа 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • STUDY00008713 (Другой идентификатор: Emory University Hospital/Winship Cancer Institute)
  • P30CA138292 (Грант/контракт NIH США)
  • U54CA284036 (Грант/контракт NIH США)
  • NCI-2025-05473 (Идентификатор реестра: CTRP (Clinical Trial Reporting Program))
  • EU6635-25 (Другой идентификатор: Emory University Hospital/Winship Cancer Institute)

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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