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Completed

NCT Number: NCT06257888

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

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.

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Key information

Conditions

Breast Neoplasm Malignant Primary Adenocarcinoma Breast Carcinoma In Situ Breast Diseases Breast Neoplasms Carcinoma Carcinoma in Situ Carcinoma, Intraductal, Noninfiltrating Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Glandular and Epithelial Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Hospital Central de Maputo

Maputo, Cidade de Maputo, 010103, Mozambique

About this study

-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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • female
  • 18 years and older
  • will undergo breast cancer treatment at HCM
  • consent to participate

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

Treatment and study plan

Patient Navigation

Other

two trained patient navigators will admit breast cancer patients to HCM, navigate them from admission to commencement of first treatment and will collect all pertinent epidemiological data and variables

Primary outcomes

  1. time interval between first symptom and first medical consultation

    Time frame: 12 months

    time interval (in days) between first symptom and first medical consultation (either at Maputo Central Hospital or any other medical service)

  2. time interval between first medical consultation and cancer diagnosis

    Time frame: 12 months

    time interval (in days) between first medical consultation (at Maputo Central Hospital) and cancer diagnosis (by any type of biopsy performed at Maputo Central Hospital)

  3. time interval between cancer diagnosis and first treatment

    Time frame: 12 months

    time interval (in days) between cancer diagnosis (by any type of biopsy performed at Maputo Central Hospital) and first treatment (surgery or neoadjuvant chemotherapy at Maputo Central Hospital)

  4. overall survival

    Time frame: 36 months after last patient recruited

    overall survival (in months) of navigated breast cancer patients

Sponsors and collaborators

Lead sponsor

Renato Cagnacci Neto

Other

Collaborators

  • AMERICAN SOCIETY FOR CLINICAL PATHOLOGY
  • Eduardo Mondlane University
  • Hospital Central de Maputo
  • M.D. Anderson Cancer Center

Registry information

Official study title

The Journey of Women With Breast Cancer in Mozambique: What is the Best Path? A Prospective Cohort With Patient Navigation as an Intervention to Reduce Treatment Disparities

Acronym: NAVIMOZ

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 14, 2024
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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