Clinical trial NCT06257888: A Prospective Cohort With Patient Navigation as an Intervention for Breast Cancer Patients
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Neoplasm Malignant Primary
Keywords: breast cancer
malignant neoplasm of the breast
patient navigation
Carcinoma, Intraductal, Noninfiltrating
Lead sponsor: AC Camargo Cancer Center
Sponsor class: OTHER
Collaborators: name: AMERICAN SOCIETY FOR CLINICAL PATHOLOGY
name: Hospital Central de Maputo
name: Eduardo Mondlane University
name: M.D. Anderson Cancer Center
First posted: 2024-02-14
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility 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

Primary outcomes:
measure: time interval between first symptom and first medical consultation
timeFrame: 12 months
measure: time interval between first medical consultation and cancer diagnosis
timeFrame: 12 months
measure: time interval between cancer diagnosis and first treatment
timeFrame: 12 months
measure: overall survival
timeFrame: 36 months after last patient recruited
Secondary outcomes:
Other outcomes:
Locations:
city: Maputo
country: Mozambique
facility: Hospital Central de Maputo
Study officials:
affiliation: AC Camargo Cancer Center
name: renato cagnacci neto, MD, MSc
role: PRINCIPAL_INVESTIGATOR
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