1170 – Randomized clinical trial: breast cancer screening based on physical examination performed by community health workers – ReBEC (RBR-39vm2nd)

Resumo

Introduction: The Itaberaí Project is an intervention based on training community health workers, grounded in evidencebased breast cancer screening through clinical breast examination.
Objective: To evaluate the effectiveness of screening actions based on clinical breast examination performed by community health workers in reducing the incidence of advanced-stage tumors (stage III and IV) and breast cancer mortality.
Methods: This was a prospective, open-label, phase III cluster-randomized clinical trial. The target population consists of
women aged 40 years or older receiving care within the Primary Health Care Network. Clusters were defined as Primary
Healthcare Units (PHU) and their respective Family Health Teams (FHT). The sample size was calculated to detect reductions in advanced-stage cases and mortality (10% and 20%, respectively). In the municipality of Itaberaí, 10 PHU comprised the study clusters and were allocated in a 1:1 ratio (5 PHU in the intervention group [IG] and 5 in the control group
[CG]). The CG receives training according to the Brazilian Ministry of Health recommendations for breast cancer screening, whereas the IG receives the same training plus additional instruction in clinical breast examination. The estimated
sample size is 4,208 participants, with 2,104 in each group.
Results: Of the expected 4,208 participants, 4,036 (96%) have been randomized to date: 2,056 (98%) in the CG and 1,980
(94%) in the IG. A total of 17 breast cancer cases (4 per 1,000 women) have been diagnosed, with 2 per 1,000 in the CG and
6 per 1,000 in the IG. Regarding clinical staging, 60% of cases in the CG were stage III and IV, compared to 25% in the IG.
Conclusion: Preliminary findings suggest that appropriately trained community health workers may effectively improve
breast cancer screening. These results may support the development of new public health policy strategies in Brazil.
Ethics: Research Ethics Committee Approval (CAAE 56916522.8.0000.5078).
Registry: Brazilian Registry of Clinical Trials (ReBEC): RBR-39vm2nd.
Funding: Natura/Avon Institute and Libbs Pharmaceuticals.
Previous Publication: https://doi.org/10.29289/259453942024V34S1005