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)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Adapted evidence-based intervention (EBI) delivery strategies (Aim 1)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 序贯
- 主要目的
- 筛查
- 盲法
- 单盲 (结局评估者)
盲法说明
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).
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 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)
排除标准
- 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
研究组 & 干预措施
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.
干预措施: Survey Administration (Other)
Aim 1 (focus group)
Participants complete a focus group over 60-90 minutes in support of the identification and selection of EBIs on study.
干预措施: Discussion (Other)
Aim 2 group I (stakeholder interview, surveys)
Participants complete a stakeholder interview and complete surveys to further inform EBI adaptation and implementation on study.
干预措施: Interview - Stakeholder (Other)
Aim 2 group I (stakeholder interview, surveys)
Participants complete a stakeholder interview and complete surveys to further inform EBI adaptation and implementation on study.
干预措施: Survey Administration (Other)
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.
干预措施: Interview - Key Informant (Other)
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.
干预措施: Interview - Ancillary studies (Other)
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.
干预措施: Best Practice (Other)
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.
干预措施: Interview - Ancillary studies (Other)
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.
干预措施: Survey Administration - Ancillary studies (Other)
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.
干预措施: Best Practice (Other)
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.
干预措施: Interview - Ancillary studies (Other)
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.
干预措施: Patient Navigation - C Components (Behavioral)
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.
干预措施: Survey Administration - Ancillary studies (Other)
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.
干预措施: Best Practice (Other)
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.
干预措施: Patient Navigation - B components (Behavioral)
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.
干预措施: Survey Administration - Ancillary studies (Other)
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.
干预措施: Best Practice (Other)
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.
干预措施: Interview - Ancillary studies (Other)
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.
干预措施: Patient Navigation - C Components (Behavioral)
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.
干预措施: Patient Navigation - B components (Behavioral)
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.
干预措施: Survey Administration - Ancillary studies (Other)
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.
干预措施: Best Practice (Other)
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.
干预措施: Interview - Ancillary studies (Other)
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.
干预措施: Patient Navigation - A components (Behavioral)
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.
干预措施: Survey Administration - Ancillary studies (Other)
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.
干预措施: Best Practice (Other)
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.
干预措施: Interview - Ancillary studies (Other)
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.
干预措施: Patient Navigation - C Components (Behavioral)
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.
干预措施: Patient Navigation - A components (Behavioral)
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.
干预措施: Survey Administration - Ancillary studies (Other)
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.
干预措施: Best Practice (Other)
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.
干预措施: Interview - Ancillary studies (Other)
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.
干预措施: Patient Navigation - B components (Behavioral)
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.
干预措施: Patient Navigation - A components (Behavioral)
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.
干预措施: Patient Navigation - A components (Behavioral)
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.
干预措施: Survey Administration - Ancillary studies (Other)
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.
干预措施: Best Practice (Other)
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.
干预措施: Interview - Ancillary studies (Other)
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.
干预措施: Patient Navigation - C Components (Behavioral)
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.
干预措施: Patient Navigation - B components (Behavioral)
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.
干预措施: Survey Administration - Ancillary studies (Other)
结局指标
主要结局
Adapted evidence-based intervention (EBI) delivery strategies (Aim 1)
时间窗: 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.
Health system resources, training, and requirements for EBI implementation (Aim 2)
时间窗: 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.
Access to screening mammography (MMG) for eligible asymptomatic women (Aim 3)
时间窗: 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).
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)
时间窗: 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).
次要结局
- Time to MMG screening (Aim 3)(Up to 2 years)
- Time to diagnostic MMG (Aim 3)(Up to 2 years)
- Time to breast ultrasound (Aim 3)(Up to 2 years)
- Time to breast biopsy (if required) (Aim 3)(Up to 2 years)
- Time to participant receipt of screening MMG result (Aim 3)(Up to 2 years)
- Time to receipt of ultrasound and/or biopsy result (Aim 3)(Up to 2 years)
- Proportion of participants who receive access to the entire (or partial) screening and diagnosis care pathway (Aim 3)(Up to 2 years)
研究者
研究点 (1)
标识符
- NCT 编号
- NCT07764796
- 其他研究编号
- STUDY00008713, NCI-2025-05473, STUDY00008713, EU6635-25, P30CA138292, U54CA284036
日期
- 首次提交
- (上个月)
- 首次发布
- (上个月)
- 主要完成日期
- (明年)
- 研究完成日期
- (2年后)
- 最近核实
- (2个月前)
- 最近更新
- (上个月)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 是否有结果
- 否