Clinical trial · Interventional
Improving Access to Breast Cancer Screening and Treatment in Nigeria: The Triple Mobile Assessment and Patient Navigation Model
NCT05321823CI-TRIAL-00057715unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breast ultrasound | Diagnostic Test | — | UNRESOLVED |
| Clinical Breast Examination | Other | — | UNRESOLVED |
| iBreast device | Device | — | UNRESOLVED |
| Mammography | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control
- description
- Two 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.
- type
- EXPERIMENTAL
- label
- Intervention
- description
- 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.
- interventionNames
- Device: iBreast device
- Other: Clinical Breast Examination
- Diagnostic Test: Breast ultrasound
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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)
References
Publications (1)
- DERIVEDOmisore 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 37310983