A Prospective Cohort With Patient Navigation as an Intervention for Breast Cancer Patients

Last updated: September 5, 2025
Sponsor: Renato Cagnacci Neto
Overall Status: Completed

Phase

N/A

Condition

Neoplasms

Treatment

patient navigation

Clinical Study ID

NCT06257888
CIBS FM&HCM/054/2023
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study Summary

The objective of this observational study is to introduce a patient navigation system within the breast cancer unit at Hospital Central de Maputo (MOZ) and gather data to assess the efficacy of patient navigation in enhancing oncological outcomes among this patient cohort. The primary inquiries it seeks to address are as follows:

  • Can patient navigation reduce the duration (in days) between patient admission and the commencement of treatment?

  • Does patient navigation influence overall survival rates when juxtaposed with historical cohorts from the local setting? Participants will receive continuous support from a patient navigator starting from admission until the initiation of any oncological treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • female

  • 18 years and older

  • will undergo breast cancer treatment at HCM

  • consent to participate

Exclusion

Exclusion Criteria:

  • male

  • less than18 years of age

  • history of other previous malignancies (including breast cancer)

  • history of breast cancer treatment initiated elsewhere

  • lack of consent to participate

Study Design

Total Participants: 90
Treatment Group(s): 1
Primary Treatment: patient navigation
Phase:
Study Start date:
March 01, 2024
Estimated Completion Date:
May 01, 2025

Study Description

-General Objective: To implement an oncological navigation platform for breast cancer patients receiving treatment at Maputo Central Hospital (HCM) over a proposed period of 12 months after project approval by the local IRB.

-Specific Objectives:

  • Develop an oncological patient navigation system for breast cancer patients treated at HCM.

  • Establish a prospective cohort of navigated breast cancer patients (with invasive or ductal carcinoma in situ) treated at HCM in 2024-25 (recruitment period of twelve months).

  • Collect diverse epidemiological data from navigated patients during the proposed study period.

  • Describe the following variables: time from first symptom until first medical consultation (in days), time from first medical consultation to cancer diagnosis (in days) and time from diagnosis to first treatment (either surgery or neoadjuvant treatment) in days.

  • Compare time from first symptom to diagnosis (in days) and time from diagnosis to first treatment (in days) to a historical cohort published by Brandão M. et al (The Oncologist, 2021).

  • Collect overall survival data in this cohort for thirty six months after last patient recruited for future publication.

Connect with a study center

  • Hospital Central de Maputo

    Maputo 1040652, Cidade de Maputo 1105845 010103
    Mozambique

    Site Not Available

  • Hospital Central de Maputo

    Maputo, 010103
    Mozambique

    Site Not Available

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