Provider-Initiated Screening Clinical Breast Examination and Patient Navigation in Sub-Saharan Africa
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 8,000
- 试验地点
- 1
- 主要终点
- Time to diagnosis of a suspicious breast lesion
研究概览
简要总结
Brief summery Prolonged presentation, along with diagnostic and treatment delays, remain significant problems for breast cancer care in sub-Saharan Africa , primarily due to low health-seeking behaviour, lack of access, long waiting times, and weak referral systems. Despite these challenges, evidence-based interventions like structured breast screening and patient navigation services are limited. To address these issues, the investigators aimed to implement a provider-initiated clinical breast examination and patient navigation intervention using an implementation mapping approach.
This is just a pragmatic implementation pilot study in the four sub-Saharan African countries that make up the Network for Oncology Research in Africa (NORA) consortium: Ethiopia, South Africa, Nigeria, and Tanzania after identifying contextual barriers and implementation determinants using a baseline assessment. The main aim of the study is to improve timely diagnosis and initiation of breast cancer treatment by implementing provider-initiated clinical breast examination and patient navigation interventions.
The study has the following key outcomes: Proportion of CBE uptake, time to diagnosis, proportion of early-stage disease, time to treatment initiation, barriers to implementation, adoption by providers and implementation fidelity The study will strictly follow the steps of implementation mapping design to select and evaluate implementation strategies to bring an evidence-based intervention. In addition, the study will apply established frameworks such as the CFIR and RE-AIM, which can strengthen the study's ability to identify, measure, and interpret multiple implementation outcomes. This study aligns with the Ministry of Health priorities of each individual countries aimed at scaling up breast cancer early detection in primary and secondary level health care settings. Therefore, it will provide evidence-based strategies that can be incorporated into the routine health care practice to address multiple points of delay in the care pathway, mainly in the early detection and referral phases at each level of the health care system. The findings will offer a promising strategy to address critical delays in the breast cancer care continuum for low & middle income settings facing similar challenges. Moreover, the findings will contribute to national and global efforts to improve breast cancer care equity and outcomes through implementation science.
详细描述
The majority of breast cancer patients experienced long delays from their initial presentation to final diagnosis and treatment initiation in sub-Saharan Africa , primarily due to low health-seeking behavior, lack of access, long waiting times for diagnostic workups, and weak referral systems. Despite these challenges, evidence-based interventions like structured breast screening using clinical breast exams and PN services are limited. CBE is offered only for those presenting with breast complaints. Standard screening tools such as mammography are very limited in the settings. This urges an urgent need for context-specific implementation strategies that are evidence-based and feasible within the constraints of the health care facilities in the countries, where patients suffer long diagnostic and treatment delays.
The investigators hypothesized that implementing provider-initiated (CBE) and PN would improve the screening uptake, timely diagnosis, and linkage to treatment for breast cancer in the region. The intervention will be implemented based on the national breast health guideline of each individual countries, which recommends using CBE and PN services with effective referral pathways. This combined approach aligns with the WHO's global breast cancer initiative (GBCI), aiming to reduce mortality through early detection and comprehensive care, and is particularly suited to low and middle income countries .
The investigators aimed to use the Implementation Mapping framework, a systematic, step-by-step methodology used to guide the development of implementation strategies that enhance the adoption, execution, and sustainability of evidence-based interventions by engaging stakeholders within local settings. This study will address a critical gap in breast cancer care by facilitating early detection, timely diagnosis, and care. Moreover, the findings will generate practical insights and scalable approaches that can inform policymakers and be expanded nationally by integrating them into the conventional healthcare system and tailoring them for other low-resource settings facing comparable issues.
Implementation process Our implementation will follow the following five steps of implementation mapping design Step 1: Conduct a needs assessment The first step is conducting a thorough assessment using the CFIR framework to gather general information on the health care infrastructure and workforce, opportunities, and challenges from the perspectives of stakeholders by conducting initial health facility surveys, IDIs, and FGDs.
Step 2: Identify adoption and implementation outcomes, performance objectives, performance determinants, and change objectives In this step, the investigators will identify the potential adoption and implementation outcomes, performance objectives, performance determinants, and change objectives based on our formative assessment findings Step 3: Select and Design Implementation Strategies
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women who are within the age range recommended for breast cancer screening according to national guidelines in the participating countries and presenting to the study facilities, including attendants, women presenting for various health services, such as outpatient care, maternal and child health services, or other health needs
- •Women presented to the facilities with any breast abnormalities
- •Women with suspicious breast lesions who will be referred to the study facilities - women who are willing to undergo CBE following informed consent
排除标准
- •Women screened for breast cancer in the past year
- •Women who have been treated for breast cancer in the past year and males will be excluded
结局指标
主要结局
Time to diagnosis of a suspicious breast lesion
时间窗: 12 month
Time from first presentation to confirmed diagnosis of suspicious breast lesion. If \< 60 days, it is considered a short interval and if ≥ 60 days, it is considered as long interval
Proportion of clinical breast examination (CBE) uptake
时间窗: 12 month
This the percentage of women who undergo CBE from the total eligible women who come to the study hospitals each working day
次要结局
- proportion of early stage diagnosis among suspecious breast lesions(12 month)
- Time to treatment initiation(12 month)
研究者
Aragaw Tesfaw
Assistant professor
Addis Ababa University