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

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.

Conditions

• Breast Cancer

Interventions

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.

Sponsors & Collaborators

• Pfizer

  collaborator INDUSTRY

• Obafemi Awolowo University

  lead OTHER

Principal Investigators

• Adeleye D Omisore, MBBS, M.Sc, FWACS, FMCR · Obafemi Awolowo University

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

70 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-12-08

Primary Completion

2023-10-31

Completion

2023-10-31

FDA Device

Yes

Countries

• Nigeria

Study Locations