An interventional study of Clinical breast examination and Navigation in Breast Cancer, sponsored by Addis Ababa University. Enrolling by invitation at 1 site in Ethiopia. Open to female participants aged 30 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Addis Ababa University · Not applicable, Interventional, and Screening
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.
The majority of breast cancer patients experienced long delays from their initial presentation to final diagnosis and treatment initiation in sub-Saharan Africa , primarily due to low health-seeking behavior, lack of access, long waiting times for diagnostic workups, and weak referral systems. Despite these challenges, evidence-based interventions like structured breast screening using clinical breast exams and PN services are limited. CBE is offered only for those presenting with breast complaints. Standard screening tools such as mammography are very limited in the settings. This urges an urgent need for context-specific implementation strategies that are evidence-based and feasible within the constraints of the health care facilities in the countries, where patients suffer long diagnostic and treatment delays.
The investigators hypothesized that implementing provider-initiated (CBE) and PN would improve the screening uptake, timely diagnosis, and linkage to treatment for breast cancer in the region. The intervention will be implemented based on the national breast health guideline of each individual countries, which recommends using CBE and PN services with effective referral pathways. This combined approach aligns with the WHO's global breast cancer initiative (GBCI), aiming to reduce mortality through early detection and comprehensive care, and is particularly suited to low and middle income countries .
The investigators aimed to use the Implementation Mapping framework, a systematic, step-by-step methodology used to guide the development of implementation strategies that enhance the adoption, execution, and sustainability of evidence-based interventions by engaging stakeholders within local settings. This study will address a critical gap in breast cancer care by facilitating early detection, timely diagnosis, and care. Moreover, the findings will generate practical insights and scalable approaches that can inform policymakers and be expanded nationally by integrating them into the conventional healthcare system and tailoring them for other low-resource settings facing comparable issues.
Implementation process Our implementation will follow the following five steps of implementation mapping design Step 1: Conduct a needs assessment The first step is conducting a thorough assessment using the CFIR framework to gather general information on the health care infrastructure and workforce, opportunities, and challenges from the perspectives of stakeholders by conducting initial health facility surveys, IDIs, and FGDs.
Step 2: Identify adoption and implementation outcomes, performance objectives, performance determinants, and change objectives In this step, the investigators will identify the potential adoption and implementation outcomes, performance objectives, performance determinants, and change objectives based on our formative assessment findings Step 3: Select and Design Implementation Strategies
In the third step, the investigators identified the following key implementation strategies that address the specific needs of receivers and implementers within the local context:
Step 4: Produce Implementation Protocols and Materials. In this step, a set of necessary protocols \& materials will be developed. This includes health education materials (audio visuals, posters, brochures), follow-up data collection tools, registration log books, screening tickets, HCP training manuals, CBE and PN SOPs, consent forms, patient navigation tracking forms, referral logbooks, post-intervention assessment tools, observation checklists, monitoring and evaluation tools.
Step 5: Evaluation of implementation outcomes In this step, a RE-AIM framework will be used to evaluate the impact of the intervention on improving each of the adoption and implementation outcomes. Surveys and interviews will be conducted with HCPs and patients to understand their perceptions and experiences with the intervention using each domain of the RE-AIM framework.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 8,000 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Addis Ababa University is the lead sponsor of 19 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Women screened for breast cancer in the past year
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Other: Clinical breast examination and Navigation
trained nurses on clinical breast examination and navigation will provide screening for all eligible women and they will follow those women who will have suspicious breast lesions until they have completed their final diagnosis of breast cancer and initiation of breast cancer treatment
Time to diagnosis of a suspicious breast lesion
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
Time frame: 12 month
Proportion of clinical breast examination (CBE) uptake
This the percentage of women who undergo CBE from the total eligible women who come to the study hospitals each working day
Time frame: 12 month
proportion of early stage diagnosis among suspecious breast lesions
This is the proportion of early-stage disease among total suspicious breast lesions identified. Tumors will be categorized according to the American Joint Committee on Cancer staging manual, 7th edition. All clinical, investigative, and intraoperative findings will be used to stage the disease. Stage 1 (T1N0); stage 2 (IIA=T0N1, T1N1 \&T2N0, IIB= T2N1\& T3N0,) and stage 3 (IIIA=T0N2, T1N2, T2N2, T3N1\&T3N2, IIIB=T4N0, T4N1, T4N2, IIIC= Any T N3) and stage 4 (any T any N and M1). Stage III and IV disease will be defined as 'late stages', and stage I and II disease will be defined as 'early stage' disease
Time frame: 12 month
Time to treatment initiation
The time from pathological diagnosis to initiation of the first breast cancer treatment if \< 30 days, it is considered as short interval and if ≥30 days, it is considered as long interval
Time frame: 12 month
Plan to share: Yes — The data for this study will be shared based on a reasonable request to the principal investigator of the study
Supporting information: Study protocol, Statistical analysis plan
Time frame: From March 21, 2026 to March 22, 2027
Access criteria: The data in this study are available from the principal investigator upon reasonable request.
Ran from Mar 2025 to primary completion in Mar 2026, 12 months.
Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's 12 months is below that.
Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Addis Ababa University