Clinical Breast Examination and Patient Navigation Intervention in Sub-Saharan Africa

March 27, 2026 updated by: Aragaw Tesfaw, Addis Ababa University

Provider-Initiated Screening Clinical Breast Examination and Patient Navigation in Sub-Saharan Africa

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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:

  1. Training healthcare providers in CBE and PN; the investigators will provide comprehensive training for HCPs on CBE and PN using practical demonstrations and role-playing scenarios to enhance their knowledge and skills.
  2. Integrating the initiative into routine clinical workflows: the clinical staff working in the hospitals will be oriented to link eligible women to navigators& those who present with breast complaints to the trained breast nurses for CBE & navigation service. We will make all the eligibility criteria and educational materials accessible to all clinical staff and ensure that the initiative becomes a routine part of care.
  3. Provider engagement and incentives; Incentive mechanisms that encourage participation in training and the adoption of CBE & PN practices will be developed. This includes recognition awards, professional development opportunities, and financial incentives based on performance metrics.
  4. Community engagement and awareness; the investigators will develop awareness creation programs within the hospitals (Morning health education in waiting areas) and community settings using posters, brochures, and social media to educate the public about the importance of breast cancer screening and early detection. Breast cancer survivors, community HEWs, and key informants will be involved to advocate for breast health and screening.
  5. Intervention delivery: The navigators will identify eligible women for CBE on each day among the facility attendants and invite them to undergo a CBE screening. Clinical staff will also identify eligible women from their daily contacts and advice, and link women to the trained nurse for CBE screening. The screening will be held every day at each site. A screening card will be given to the screened women with the date of last screening and the date when the next screening will be. The navigators will have direct communication with clinical staff daily. Navigators will contact referred patients by phone within 2 days of referral, collect baseline data, provide counselling on follow-up and undergoing further evaluation, give date for follow-up within 14 days of referral, send SMS reminder to patient 3 and 1 days before scheduled follow-up, follow-up on whether patient presented for first evaluation at diagnostic center, follow-up 45 days post-referral to check whether patient has completed all recommended testing, keep records of patients' progress until evaluation of breast (confirmed diagnosis) is complete. The navigator will have communications with the referral center to assist her until she finishes all the diagnoses. Local community HEWs will be used to trace women in case access by phone is difficult. The Redcap database will be used to track patient progress and to generate reports that support navigators' and screener's workflow.
  6. Monitoring and Feedback: A structured follow-up tool will be developed to track key performance indicators (KPIs) such as the number of CBEs performed, referrals made, and time to diagnosis recorded through the RedCap database. The supervisory team will hold weekly meetings with the providers and monthly onsite supervisions to monitor the progress and ensure adherence to the protocol. Daily feedback will be provided to providers on their performance to encourage continuous improvement.
  7. Collaboration with stakeholders; stakeholders at local and national levels, including the regional and MOH officials, local NGOs, hospital leaders, patients, HEWs, and research and academic institutions, will be involved.
  8. Addressing barriers to care; a dedicated healthcare professional (trained breast nurses) will be assigned to identify barriers and to guide patients through the healthcare system
  9. Sustainability planning; the intervention is being implemented according to the newly launched national breast health guideline recommendations. Ongoing training and support for providers will be planned for the long-term integration of the intervention into routine practice.

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.

Study Type

Interventional

Enrollment (Estimated)

8000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ethiopia
    • Addis Ababa
      • Addis Ababa, Addis Ababa, Ethiopia, 9086
        • Primary and secondary health care facilities from four sub-Saharan African countries that make up the Network for Oncology Research in Africa (NORA) consortium: Ethiopia, South Africa, Nigeria, and Tanzania.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Clinical breast examination and navigation
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to diagnosis of a suspicious breast lesion
Time Frame: 12 month
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
12 month
Proportion of clinical breast examination (CBE) uptake
Time Frame: 12 month
This the percentage of women who undergo CBE from the total eligible women who come to the study hospitals each working day
12 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
proportion of early stage diagnosis among suspecious breast lesions
Time Frame: 12 month
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
12 month
Time to treatment initiation
Time Frame: 12 month
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
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Addis Ababa University

Collaborators

Martin-Luther-Universität Halle-Wittenberg
University of the Witwatersrand, South Africa
Institute of Human Virology, Nigeria
Kilimanjaro Clinical Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 24, 2025

Primary Completion (Estimated)

March 24, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

June 5, 2025

First Submitted That Met QC Criteria

June 12, 2025

First Posted (Actual)

June 15, 2025

Study Record Updates

Last Update Posted (Actual)

April 1, 2026

Last Update Submitted That Met QC Criteria

March 27, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPH 034/24/SPH, MLU 2025-123
  • (BMFTR) 01KA2220B (Other Grant/Funding Number: the Network for Oncology Research in Africa (NORA))
  • Del-22-008 (Other Grant/Funding Number: the Science for Africa Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data for this study will be shared based on a reasonable request to the principal investigator of the study

IPD Sharing Time Frame

From March 21, 2026 to March 22, 2027

IPD Sharing Access Criteria

The data in this study are available from the principal investigator upon reasonable request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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