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

Renato Cagnacci Neto

Status: Completed

Conditions: Breast Neoplasm Malignant Primary

Treatments: Other: patient navigation

Study type: Observational

Funder types: Other

Identifiers

NCT06257888

CIBS FM&HCM/054/2023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

90 participants in 1 patient group

breast cancer patients under navigation

Description:

breast cancer patients, intervention = patient navigation

Treatment:

Other: patient navigation