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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05321823
• Other study ID #: ERC/2020/10/11 (26/10/2020)
• Secondary ID: #60303257
• Status: Recruiting
• Phase: N/A
• Start date: December 8, 2021
• Est. completion date: October 31, 2023

Study information

• Verified date: April 2022
• Source: Obafemi Awolowo University
• Contact: Adeleye D Omisore, MBBS, M.Sc, FWACS, FMCR
• Phone: +234803538004
• Email: leyeomisore[@]oauife.edu.ng
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4100
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
Nigeria	Obafemi Awolowo University Teaching Hospitals Complex	Ile Ife	Osun

Sponsors (2)

Lead Sponsor	Collaborator
Obafemi Awolowo University	Pfizer

Country where clinical trial is conducted

Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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