Improving Access to Breast Cancer Screening and Treatment in Nigeria: The Triple Mobile Assessment and Patient Navigation Model
- Conditions
- Breast Cancer
- Interventions
- Device: iBreast deviceOther: Clinical Breast ExaminationDiagnostic Test: Breast ultrasoundDiagnostic Test: Mammography
- Registration Number
- NCT05321823
- Lead Sponsor
- Obafemi Awolowo University
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 4100
- Asymptomatic women 40 - 70 years
- Symptomatic women (with breast-related symptoms) 30 - 70 years
- Male subjects
- Women living outside the study locations (Ife East and Ife North districts)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Mammography 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. Intervention Clinical Breast Examination 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. Intervention Breast ultrasound 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. Intervention iBreast device 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.
- Primary Outcome Measures
Name Time Method Stage at presentation After year 1 of the 2-year study period The tumour, node and metastasis (TNM) stage among those with histologically confirmed breast cancer.
Retention rate After year 2 of the 2-year study period Number of women who return for repeat annual screening of the total initial number of women screened.
Timeline from presentation to treatment After year 1 of the 2-year study period Time interval between presentation for screening in the community and treatment in the tertiary hospital
Participation rate After year 1 of the 2-year study period Percentage of women screened of the total number of eligible women in each community.
Abnormal call rate After year 1 of the 2-year study period 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.
Breast cancer detection rate After year 1 of the 2-year study period Number of histologically diagnosed cases of breast cancer per 1,000 screened populations.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Obafemi Awolowo University Teaching Hospitals Complex
🇳🇬Ile Ife, Osun, Nigeria