Improving Access to Breast Cancer Screening and Treatment in Nigeria: The Triple Mobile Assessment and Patient Navigation Model
2 other identifiers
interventional
4,100
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Dec 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 8, 2021
CompletedFirst Submitted
Initial submission to the registry
March 24, 2022
CompletedFirst Posted
Study publicly available on registry
April 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2023
CompletedApril 11, 2022
April 1, 2022
1.9 years
March 24, 2022
April 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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
Study Arms (2)
Control
NO INTERVENTIONTwo 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.
Intervention
EXPERIMENTALThree 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.
Interventions
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.
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
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.
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.
Eligibility Criteria
You may qualify if:
- Asymptomatic women 40 - 70 years
- Symptomatic women (with breast-related symptoms) 30 - 70 years
You may not qualify if:
- Male subjects
- Women living outside the study locations (Ife East and Ife North districts)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Obafemi Awolowo Universitylead
- Pfizercollaborator
Study Sites (1)
Obafemi Awolowo University Teaching Hospitals Complex
Ile-Ife, Osun State, 220213, Nigeria
Related Publications (1)
Omisore AD, Olasehinde O, Wuraola FO, Sutton EJ, Sevilimedu V, Omoyiola OZ, Romanoff A, Owoade IA, Olaitan AF, Kingham TP, Alatise OI, Mango VL. Improving access to breast cancer screening and treatment in Nigeria: The triple mobile assessment and patient navigation model (NCT05321823): A study protocol. PLoS One. 2023 Jun 13;18(6):e0284341. doi: 10.1371/journal.pone.0284341. eCollection 2023.
PMID: 37310983DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adeleye D Omisore, MBBS, M.Sc, FWACS, FMCR
Obafemi Awolowo University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
March 24, 2022
First Posted
April 11, 2022
Study Start
December 8, 2021
Primary Completion
October 31, 2023
Study Completion
October 31, 2023
Last Updated
April 11, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- The data can be available beginning 12 months after publication of the study results up to to 36 months post publication.
- Access Criteria
- Researchers with approved proposals
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.