NCT05321823

Improving Access to Breast Cancer Screening and Treatment in Nigeria: The Triple Mobile Assessment and Patient Navigation Model

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 4,100 (estimated)
• Sponsor: Obafemi Awolowo University · Academic / Other
• Sex: Female
• Age: 30 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The goal of this study is to establish a novel community-based breast cancer program to address delayed presentation and lack of access to diagnostic and treatment facilities in South-West Nigeria. It is aimed at evaluating the impact of a novel breast cancer early detection program using triple mobile assessment (innovative handheld iBreast Exam \[iBE\] device, mobile ultrasound, and mobile mammography) and patient navigation program in a Nigerian community.

Detailed description

This study aims to provide screening to asymptomatic women 40-70 years and to provide diagnostic evaluation to women 30-70 years presenting with breast symptoms in a community in South-West Nigeria. The project will use a cluster randomized design with 1 community serving as the intervention arm and another community serving as the control arm. Both communities will receive breast cancer awareness and education but only the intervention community will receive screening, mobile imaging and navigation. Screening with targeted clinical history, Clinical Breast Exam (CBE), and iBE will be performed by trained Community Health Nurses in the intervention community. Women with positive CBE or iBE findings will undergo breast imaging with mobile mammography and portable ultrasound, as well as biopsy when indicated by the Radiologist who visits the community once a month, and receive navigation by the nurses to the point of care. The control population will receive breast cancer awareness without an organized screening, imaging or navigation program. Women presenting to the Primary Health Care Centers in the control community will be referred to the Teaching Hospital as per current standard of care. Record of all breast cancer cases seen in the 2 communities during the study period will be obtained.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	iBreast device	The iBreast (iBE) device is an automated, battery powered, portable device designed to be used by community health nurses as a screening and triage tool. The iBE is designed to be used by a community health worker or lay person after appropriate training. In resource-limited settings, it potentially provides an easily accessible, low-cost method to assess the breast for findings that warrant further evaluation.
OTHER	Clinical Breast Examination	The standard clinical breast examination (CBE) will be performed by the community health nurses in the selected primary health care centers where patients will present for screening or diagnostic workup in the intervention community
DIAGNOSTIC_TEST	Breast ultrasound	Women in the intervention community who have positive iBE and/or CBE findings will be navigated by the community health nurses to have ultrasound with or without ultrasound-guided breast biopsy if indicated by the radiologist using portable ultrasound tablets that will be brought to the intervention community.
DIAGNOSTIC_TEST	Mammography	Women in the intervention community who have positive iBE and/or CBE findings will be navigated by the community health nurses to have mammography done using a mobile mammography van that will be brought to the intervention community.

Timeline

• Start date: 2021-12-08
• Primary completion: 2023-10-31
• Completion: 2023-10-31
• First posted: 2022-04-11
• Last updated: 2022-04-11

Locations

1 site across 1 country: Nigeria

Regulatory

• FDA-regulated device study