Clinical trial · Interventional
Clinical Breast Examination and Patient Navigation Intervention in Sub-Saharan Africa
Provider-Initiated Screening Clinical Breast Examination and Patient Navigation in Sub-Saharan Africa
- 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)
Brief summery Prolonged presentation, along with diagnostic and treatment delays, remain significant problems for breast cancer care in sub-Saharan Africa , primarily due to low health-seeking behaviour, lack of access, long waiting times, and weak referral systems. Despite these challenges, evidence-based interventions like structured breast screening and patient navigation services are limited. To address these issues, the investigators aimed to implement a provider-initiated clinical breast examination and patient navigation intervention using an implementation mapping approach. This is just a pragmatic implementation pilot study in the four sub-Saharan African countries that make up the Network for Oncology Research in Africa (NORA) consortium: Ethiopia, South Africa, Nigeria, and Tanzania after identifying contextual barriers and implementation determinants using a baseline assessment. The main aim of the study is to improve timely diagnosis and initiation of breast cancer treatment by implementing provider-initiated clinical breast examination and patient navigation interventions. The study has the following key outcomes: Proportion of CBE uptake, time to diagnosis, proportion of early-stage disease, time to treatment initiation, barriers to implementation, adoption by providers and implementation fidelity The study will strictly follow the steps of implementation mapping design to select and evaluate implementation strategies to bring an evidence-based intervention. In addition, the study will apply established frameworks such as the CFIR and RE-AIM, which can strengthen the study's ability to identify, measure, and interpret multiple implementation outcomes. This study aligns with the Ministry of Health priorities of each individual countries aimed at scaling up breast cancer early detection in primary and secondary level health care settings. Therefore, it will provide evidence-based strategies that can be incorporated into the routine health care practice to address multiple points of delay in the care pathway, mainly in the early detection and referral phases at each level of the health care system. The findings will offer a promising strategy to address critical delays in the breast cancer care continuum for low \& middle income settings facing similar challenges. Moreover, the findings will contribute to national and global efforts to improve breast cancer care equity and outcomes through implementation science.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clinical breast examination and Navigation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Clinical breast examination and navigation
- description
- Nurses will be trained on clinical breast examination techniques and navigation to routinely offer CBE to eligible women and to support women with suspicious findings until compilation of diagnosis and Initiation of breast cancer treatment
- interventionNames
- Other: Clinical breast examination and Navigation
Primary outcomes (2)
- measure
- Time to diagnosis of a suspicious breast lesion
- timeFrame
- 12 month
- description
- Time from first presentation to confirmed diagnosis of suspicious breast lesion. If \< 60 days, it is considered a short interval and if ≥ 60 days, it is considered as long interval
- measure
- Proportion of clinical breast examination (CBE) uptake
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
Show eligibility criteria text
Inclusion Criteria: * women who are within the age range recommended for breast cancer screening according to national guidelines in the participating countries and presenting to the study facilities, including attendants, women presenting for various health services, such as outpatient care, maternal and child health services, or other health needs * Women presented to the facilities with any breast abnormalities * Women with suspicious breast lesions who will be referred to the study facilities - women who are willing to undergo CBE following informed consent Exclusion Criteria: * Women screened for breast cancer in the past year * Women who have been treated for breast cancer in the past year and males will be excluded
References
Publications (16)
- BACKGROUNDPace LE, Dusengimana JV, Keating NL, Hategekimana V, Rugema V, Bigirimana JB, Costas-Chavarri A, Umwizera A, Park PH, Shulman LN, Mpunga T. Impact of Breast Cancer Early Detection Training on Rwandan Health Workers' Knowledge and Skills. J Glob Oncol. 2018 Sep;4:1-10. doi: 10.1200/JGO.17.00098. PMID 30241228
- BACKGROUNDHoffman HJ, LaVerda NL, Young HA, Levine PH, Alexander LM, Brem R, Caicedo L, Eng-Wong J, Frederick W, Funderburk W, Huerta E, Swain S, Patierno SR. Patient navigation significantly reduces delays in breast cancer diagnosis in the District of Columbia. Cancer Epidemiol Biomarkers Prev. 2012 Oct;21(10):1655-63. doi: 10.1158/1055-9965.EPI-12-0479. PMID 23045540
- BACKGROUNDRabe F, Getachew S, Stroetmann CY, Mezger NCS, Gebremariam TY, Berhane B, Mremi A, Mmbaga BT, Boucheron P, McCormack V, Santos P, Addissie A, Kantelhardt EJ. Time to pathologic diagnosis of suspicious breast lesions: An institution-based study in five Ethiopian hospitals. Int J Cancer. 2025 Sep 1;157(5):876-889. doi: 10.1002/ijc.35436. Epub 2025 Apr 10. PMID 40207740
- BACKGROUNDRohsig V, Silva P, Teixeira R, Lorenzini E, Maestri R, Saraiva T, Souza A. Nurse Navigation Program: Outcomes From a Breast Cancer Center in Brazil. Clin J Oncol Nurs. 2019 Feb 1;23(1):E25-E31. doi: 10.1188/19.CJON.E25-E31. PMID 30682003
- BACKGROUNDKhanna AS, Brickman B, Cronin M, Bergeron NQ, Scheel JR, Hibdon J, Calhoun EA, Watson KS, Strayhorn SM, Molina Y. Patient Navigation Can Improve Breast Cancer Outcomes among African American Women in Chicago: Insights from a Modeling Study. J Urban Health. 2022 Oct;99(5):813-828. doi: 10.1007/s11524-022-00669-9. Epub 2022 Aug 8. PMID 35941401
- BACKGROUNDSankaranarayanan R, Ramadas K, Thara S, Muwonge R, Prabhakar J, Augustine P, Venugopal M, Anju G, Mathew BS. Clinical breast examination: preliminary results from a cluster randomized controlled trial in India. J Natl Cancer Inst. 2011 Oct 5;103(19):1476-80. doi: 10.1093/jnci/djr304. Epub 2011 Aug 23.