Department of Radiology, Obafemi Awolowo University, Ile Ife, Osun State, Nigeria.
African Research Group for Oncology, Obafemi Awolowo University Teaching Hospitals Complex, Ile Ife, Osun State, Nigeria.
PLoS One. 2023 Jun 13;18(6):e0284341. doi: 10.1371/journal.pone.0284341. eCollection 2023.
In Nigeria, breast cancer incidence is rising, late presentation is common, and outcomes are poor. Patient-related factors such as lack of awareness and misperceptions in addition to health system deficiencies such as lack of a clearly defined framework for breast cancer screening and referral are some of the major drivers of this poor outlook. Guidelines for breast cancer screening in high-income countries have limited applicability in low-middle-income countries, hence the need for innovative, resource-compatible strategies to combat the negative trend. This manuscript presents our study protocol which aims to evaluate the impact of a novel breast cancer early detection program developed to address delayed presentation and lack of access to diagnostic and treatment facilities in South-West Nigeria. This entails the use of mobile technology (innovative handheld iBreast Exam [iBE] device, mobile breast ultrasound, and mobile mammography) and patient navigation as interventions at the community level.
The study (ClinicalTrials.gov identifier: NCT05321823) will adopt a randomized two group clinical trial design with one local government area (LGA) serving as an intervention arm and another serving as the control. Both LGAs will receive breast cancer awareness education but only one will receive the interventions. In the intervention arm, asymptomatic (40-70 years) and symptomatic (30-70 years) women will be invited for breast evaluation which will be performed by trained Community Health Nurses using Clinical Breast Exam (CBE), and iBE. Those with positive findings will proceed to imaging using mobile mammography and ultrasound brought to the LGA every month. Symptomatic women with negative findings on CBE and iBE will be scheduled for repeat clinical evaluation on a short-term basis (one month). The Radiologist will obtain core needle biopsies as indicated and transfer them for prompt pathological assessment. Women presenting to the Primary Healthcare Centers in the control LGA will be referred directly to Obafemi Awolowo University Teaching Hospitals Complex as per the current standard of care. Records of all breast cancer cases seen in the two LGAs during the study period will be obtained. The program metrics will include screening participation rate, cancer detection rate, stage at diagnosis, and timeline from detection to initiation of treatment. The stage at diagnosis and timeline from detection to treatment compared between the two LGAs will be used to assess the impact of the intervention. The study is proposed for 2 years; however, a descriptive analysis will be carried out at 1.5 years to evaluate the retention of the study participants.
It is anticipated that this study will provide vital data to support wider breast cancer screening efforts in Nigeria.
在尼日利亚，乳腺癌的发病率正在上升，就诊时间较晚且预后较差。除了卫生系统缺乏明确的乳腺癌筛查和转诊框架等因素外，患者相关因素，如缺乏意识和误解，也是导致这种不良预后的主要原因之一。高收入国家的乳腺癌筛查指南在中低收入国家的适用性有限，因此需要创新、资源兼容的策略来应对这一负面趋势。本文介绍了我们的研究方案，旨在评估一种新的乳腺癌早期检测计划的效果，该计划旨在解决南非西南部地区就诊时间晚和缺乏诊断及治疗设施的问题。这需要在社区层面使用移动技术（创新的手持式 iBreastExam[iBE]设备、移动乳腺超声和移动乳腺 X 光摄影）和患者导航作为干预措施。
本研究（临床试验.gov 标识符：NCT05321823）将采用随机两组临床试验设计，一个地方政府区（LGA）作为干预组，另一个作为对照组。两个 LGA 都将接受乳腺癌意识教育，但只有一个 LGA 将接受干预措施。在干预组中，将邀请无症状（40-70 岁）和有症状（30-70 岁）的女性进行乳房评估，由经过培训的社区卫生护士使用临床乳房检查（CBE）和 iBE 进行。有阳性发现的患者将使用每月带到 LGA 的移动乳房 X 光摄影和超声进行影像学检查。对 CBE 和 iBE 检查结果阴性的有症状女性将在短期内（一个月）重新进行临床评估。放射科医生将根据需要进行核心针活检，并将其转移以进行快速病理评估。在对照组 LGA 就诊的初级保健中心的所有乳腺癌病例将按照现行的护理标准直接转介到奥巴费米·阿沃洛沃大学教学医院综合医院。研究期间两个 LGA 中所有乳腺癌病例的记录将被获取。该方案的指标将包括筛查参与率、癌症检出率、诊断时的分期以及从检出到开始治疗的时间线。将使用两个 LGA 之间的诊断分期和从检出到治疗的时间线比较来评估干预的效果。该研究计划进行 2 年，但将在 1.5 年进行描述性分析，以评估研究参与者的保留率。
预计这项研究将提供重要数据，以支持尼日利亚更广泛的乳腺癌筛查工作。
