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

September 5, 2025 updated by: Renato Cagnacci Neto

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mozambique
    • Cidade de Maputo
      • Maputo, Cidade de Maputo, Mozambique, 010103
        • Hospital Central De Maputo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

we will recruit all female primary breast cancer patients (invasive or in situ) admitted for treatment at HCM during a 12 month period

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
breast cancer patients under navigation
breast cancer patients, intervention = patient navigation
Other: patient navigation
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
12 months
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)
12 months
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)
12 months
overall survival
Time Frame: 36 months after last patient recruited
overall survival (in months) of navigated breast cancer patients
36 months after last patient recruited

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Renato Cagnacci Neto

Collaborators

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

Investigators

  • Principal Investigator: renato cagnacci neto, MD, MSc, AC Camargo Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Actual)

April 1, 2025

Study Completion (Actual)

May 1, 2025

Study Registration Dates

First Submitted

February 6, 2024

First Submitted That Met QC Criteria

February 6, 2024

First Posted (Actual)

February 14, 2024

Study Record Updates

Last Update Posted (Estimated)

September 11, 2025

Last Update Submitted That Met QC Criteria

September 5, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIBS FM&HCM/054/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

we will share all collected IPD with any researchers that contact the PI

IPD Sharing Time Frame

available after publication for one year

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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