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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Device: iBreast device; Other: Clinical Breast Examination; Diagnostic test: Breast ultrasound; Diagnostic test: Mammography

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.

• Study Type: Interventional
• Enrollment (Anticipated): 4100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adeleye D Omisore, MBBS, M.Sc, FWACS, FMCR; Phone Number: +234803538004; Email: leyeomisore@oauife.edu.ng

Study Locations

• Nigeria
  • Osun
    • Ile Ife, Osun, Nigeria, 220213
      • Recruiting
      • Obafemi Awolowo University Teaching Hospitals Complex
      • Contact: Adeleye D Omisore, MBBS, M.Sc, FWACS, FMCR; Phone Number: +2348031538004; Email: leyeomisore@oauife.edu.ng
      • Principal Investigator: Adeleye D Omisore, MBBS, M.Sc, FWACS, FMCR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Asymptomatic women 40 - 70 years
• Symptomatic women (with breast-related symptoms) 30 - 70 years

Exclusion Criteria:

• Male subjects
• Women living outside the study locations (Ife East and Ife North districts)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Two districts in Ife East Local County with an estimated screening population of 4,500 will be randomly selected to serve as the control community. The control arm will not receive iBE screening and clinical breast examinations by the community health nurses and nor get navigated to have ultrasound, mammography, biopsy and referral for treatment to the tertiary hospital if indicated within their community. All women for screening and diagnostic workup in the control community will be directed to the tertiary hospital to receive breast care.
Experimental: Intervention; Three districts in Ife North Local County with an estimated screening population (women 40-70 years) of 5,800 will be randomly selected to serve as the intervention community. Women in the intervention community will receive iBreast and clinical breast examinations by the community health nurses and get navigated to have ultrasound, mammography, biopsy and referral for treatment to the tertiary hospital if indicated within their community.	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 Names: UE Life Sciences Inc.; 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; Other Names: CBE; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participation rate	Percentage of women screened of the total number of eligible women in each community.	After year 1 of the 2-year study period
Abnormal call rate	Number of women with abnormalities detected on iBE and/or CBE requiring further evaluation either by imaging or biopsy out of the total number of women screened.	After year 1 of the 2-year study period
Breast cancer detection rate	Number of histologically diagnosed cases of breast cancer per 1,000 screened populations.	After year 1 of the 2-year study period
Stage at presentation	The tumour, node and metastasis (TNM) stage among those with histologically confirmed breast cancer.	After year 1 of the 2-year study period
Timeline from presentation to treatment	Time interval between presentation for screening in the community and treatment in the tertiary hospital	After year 1 of the 2-year study period
Retention rate	Number of women who return for repeat annual screening of the total initial number of women screened.	After year 2 of the 2-year study period

Collaborators and Investigators

• Sponsor: Obafemi Awolowo University
• Collaborators: Pfizer
• Investigators: Principal Investigator: Adeleye D Omisore, MBBS, M.Sc, FWACS, FMCR, Obafemi Awolowo University

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2021
• Primary Completion (Anticipated): October 31, 2023
• Study Completion (Anticipated): October 31, 2023

Study Registration Dates

• First Submitted: March 24, 2022
• First Submitted That Met QC Criteria: April 4, 2022
• First Posted (Actual): April 11, 2022

Study Record Updates

• Last Update Posted (Actual): April 11, 2022
• Last Update Submitted That Met QC Criteria: April 4, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Treatment; Screening; Navigation; Triple Mobile assessment
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: ERC/2020/10/11 (26/10/2020); #60303257 (Other Grant/Funding Number: Pfizer Inc.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study protocol, statistical analysis plan, and informed consent form will be made available on clinicaltrials.gov if and when required. With study data being uploaded to redcap hosted by the sponsor organization (Obafemi Awolowo University), de-identified individual participant data can be made available under the terms of a data use agreement 12 moths after publication of study results.
• IPD Sharing Time Frame: The data can be available beginning 12 months after publication of the study results up to to 36 months post publication.
• IPD Sharing Access Criteria: Researchers with approved proposals
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes