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

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

Interventions

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

Sponsors & Collaborators

• Martin-Luther-Universität Halle-Wittenberg

  collaborator OTHER

• University of the Witwatersrand, South Africa

  collaborator UNKNOWN

• Kilimanjaro Clinical Research Institute

  collaborator OTHER

• Institute of Human Virology, Nigeria

  collaborator OTHER

• Addis Ababa University

  lead OTHER

Study Design

Allocation

NA

Purpose

SCREENING

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

30 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-03-24

Primary Completion

2026-03-24

Completion

2027-03-31

Countries

• Ethiopia

Study Locations