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Trial Title:
A Prospective Cohort With Patient Navigation as an Intervention for Breast Cancer Patients
NCT ID:
NCT06257888
Condition:
Breast Neoplasm Malignant Primary
Conditions: Official terms:
Breast Neoplasms
Neoplasms
Conditions: Keywords:
breast cancer
malignant neoplasm of the breast
patient navigation
Carcinoma, Intraductal, Noninfiltrating
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
patient navigation
Description:
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
Arm group label:
breast cancer patients under navigation
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.
- Collect diverse epidemiological data from navigated patients during the proposed
study period.
- Compare the time interval (in days) between admission to HCM and initiation of
cancer treatment (surgery or systemic treatment) among patients in this cohort
versus patients already treated in the service with available data in the National
Cancer Registry (NCR).
- Compare overall survival between patients in this cohort and a locally published
historical cohort from 2020.
Criteria for eligibility:
Study pop:
we will recruit all female primary breast cancer patients (invasive or in situ) admitted
for treatment at HCM during a 12 month period
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Hospital Central de Maputo
Address:
City:
Maputo
Zip:
010103
Country:
Mozambique
Status:
Recruiting
Contact:
Last name:
cesaltina lorenzoni, MD, PhD
Phone:
+258873822831
Email:
ferreira.cesaltina@gmail.com
Contact backup:
Last name:
leonildo soares, MD
Phone:
+258823872257
Email:
gnildo@yahoo.com.br
Investigator:
Last name:
leonildo soares, MD
Email:
Sub-Investigator
Investigator:
Last name:
cesaltina lorenzoni, MD, PhD
Email:
Principal Investigator
Start date:
March 1, 2024
Completion date:
May 2025
Lead sponsor:
Agency:
Renato Cagnacci Neto
Agency class:
Other
Collaborator:
Agency:
AMERICAN SOCIETY FOR CLINICAL PATHOLOGY
Agency class:
Other
Collaborator:
Agency:
Hospital Central de Maputo
Agency class:
Other
Collaborator:
Agency:
Eduardo Mondlane University
Agency class:
Other
Collaborator:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Source:
AC Camargo Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06257888
