Improving Access to Breast Cancer Screening and Treatment in Nigeria: The Triple Mobile Assessment and Patient Navigation Model
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Obafemi Awolowo University
- Enrollment
- 4100
- Locations
- 1
- Primary Endpoint
- Timeline from presentation to treatment
- Last Updated
- 4 years ago
Overview
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.
Investigators
Adeleye Omisore
Dr.
Obafemi Awolowo University
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Timeline from presentation to treatment
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: After year 1 of the 2-year study period
Number of histologically diagnosed cases of breast cancer per 1,000 screened populations.
Stage at presentation
Time Frame: 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
Time Frame: 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.