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Clinical Trials/NCT06257888
NCT06257888
Completed
N/A

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

Renato Cagnacci Neto1 site in 1 country90 target enrollmentMarch 1, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Breast Neoplasm Malignant Primary
Sponsor
Renato Cagnacci Neto
Enrollment
90
Locations
1
Primary Endpoint
time interval between first symptom and first medical consultation
Status
Completed
Last Updated
7 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2024
End Date
May 1, 2025
Last Updated
7 months ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Renato Cagnacci Neto
Responsible Party
Sponsor Investigator
Principal Investigator

Renato Cagnacci Neto

Principal Investigator

AC Camargo Cancer Center

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

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)

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)

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)

overall survival

Time Frame: 36 months after last patient recruited

overall survival (in months) of navigated breast cancer patients

Study Sites (1)

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