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

NCT07023198 | Active Not Recruiting DMC

• 3 other identifiers: SPH 034/24/SPH, MLU 2025-123(BMFTR) 01KA2220BDel-22-008
• Study Type: interventional
• Target: 8,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Cancer

Keywords

breast cancer screening; Patient navigation; implementation research; Ethiopia

Outcome Measures

Primary Outcomes (2)

• 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

  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

  12 month

Secondary Outcomes (2)

• proportion of early stage diagnosis among suspecious breast lesions

  12 month

• Time to treatment initiation

  12 month

Study Arms (1)

Clinical breast examination and navigation

EXPERIMENTAL

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

Interventions

Clinical breast examination and Navigation OTHER

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

Clinical breast examination and navigation

Eligibility Criteria

• Age: 30 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Addis Ababa University: lead
• Martin-Luther-Universität Halle-Wittenberg: collaborator
• University of the Witwatersrand, South Africa: collaborator
• Kilimanjaro Clinical Research Institute: collaborator
• Institute of Human Virology, Nigeria: collaborator

Study Sites (1)

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.

Addis Ababa, Addis Ababa, 9086, Ethiopia

Location

Related Publications (16)

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MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: An implementation mapping based pilot study will be conducted which is a process framework that provides a systematic, five-step approach to select and evaluate implementation strategies to bring an evidence-based intervention. This design includes: 1) conducting a needs assessment, (2) identify adoption and implementation outcomes, performance objectives, performance determinants, and change objectives), (3) select \& design implementation strategies, (4) produce implementation protocols and materials and (5) evaluate implementation outcomes (1). The RE-AIM framework will also be used to evaluate the implementation process and outcome. It is a comprehensive model designed to evaluate and enhance the impact of health interventions, by considering individual and organizational factors that influence the success of health interventions

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 15, 2025
• Study Start: March 24, 2025
• Primary Completion: March 24, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.

Locations

ET (1)