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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06257888
Acronym
NAVIMOZ
Enrollment
90
Registered
2024-02-14
Start date
2024-03-01
Completion date
2025-05-01
Last updated
2025-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasm Malignant Primary

Keywords

breast cancer, malignant neoplasm of the breast, patient navigation, Carcinoma, Intraductal, Noninfiltrating

Brief 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.

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.

Interventions

OTHERpatient 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

Sponsors

AMERICAN SOCIETY FOR CLINICAL PATHOLOGY
CollaboratorUNKNOWN
Hospital Central de Maputo
CollaboratorUNKNOWN
Eduardo Mondlane University
CollaboratorOTHER
M.D. Anderson Cancer Center
CollaboratorOTHER
Renato Cagnacci Neto
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
time interval between first symptom and first medical consultation12 monthstime interval (in days) between first symptom and first medical consultation (either at Maputo Central Hospital or any other medical service)
time interval between first medical consultation and cancer diagnosis12 monthstime interval (in days) between first medical consultation (at Maputo Central Hospital) and cancer diagnosis (by any type of biopsy performed at Maputo Central Hospital)
time interval between cancer diagnosis and first treatment12 monthstime 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)
overall survival36 months after last patient recruitedoverall survival (in months) of navigated breast cancer patients

Countries

Mozambique

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026