Clinical trial NCT05321823: Improving Access to Breast Cancer Screening and Treatment in Nigeria: The Triple Mobile Assessment and Patient Navigation Model
Official title: Improving Access to Breast Cancer Screening and Treatment in Nigeria: The Triple Mobile Assessment and Patient Navigation Model
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: Screening
Treatment
Navigation
Triple Mobile assessment
Lead sponsor: Obafemi Awolowo University
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2022-04-11
Enrollment: 4100
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will be carried out in 2 local counties (Local Government Areas) in Osun State, South-West, Nigeria, Ife North Local County and Ife East Local County. 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, while 2 districts in Ife East Local County with an estimated screening population of 4,500 will be randomly selected to serve as the control community. Both communities will receive awareness and education, but only the intervention community will receive screening and navigation.
Primary purpose: SCREENING

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.

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)

Primary outcomes:
measure: Participation rate
timeFrame: After year 1 of the 2-year study period
measure: Abnormal call rate
timeFrame: After year 1 of the 2-year study period
measure: Breast cancer detection rate
timeFrame: After year 1 of the 2-year study period
measure: Stage at presentation
timeFrame: After year 1 of the 2-year study period
measure: Timeline from presentation to treatment
timeFrame: After year 1 of the 2-year study period
measure: Retention rate
timeFrame: After year 2 of the 2-year study period
Secondary outcomes:
Other outcomes:
Locations:
city: Ile Ife
country: Nigeria
facility: Obafemi Awolowo University Teaching Hospitals Complex
state: Osun
Study officials:
affiliation: Obafemi Awolowo University
name: Adeleye D Omisore, MBBS, M.Sc, FWACS, FMCR
role: PRINCIPAL_INVESTIGATOR
References: