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Trial Title:
Online Patient Navigation Program for Patients with Breast Cancer
NCT ID:
NCT06597773
Condition:
Breast Cancer
Supportive Care in Cancer
Patient Navigation
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
breast cancer
supportive care
patient navigation
online patient navigation
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Single (Outcomes Assessor)
Masking description:
Given the nature of the intervention, the study will be open and participants will know
which group they were randomized to. However, the study will be blinded to the
statistician in order to reduce the risk of introducing bias when interpreting the data.
Intervention:
Intervention type:
Other
Intervention name:
Online patient navigation and supportive care referrals
Description:
In the online patient navigation program, a navigator will use validated instruments to
identify participants' need for nutrition, psychology, and sexology counseling,
and will refer them to the required services. Referrals will be made to web-based,
systematic supportive care resources consisting of pre-recorded videos led by specialists
and which will be available on a study-specific website, allowing each participant to
access the resources as soon as they receive a referral. Additionally, online support
groups will be held monthly to complement the supportive care programs.
Arm group label:
Online patient navigation and supportive care referrals
Intervention type:
Other
Intervention name:
In-person patient navigation and supportive care referrals
Description:
In the in-person patient navigation program, a navigator will use validated instruments
to identify participants' need for nutrition, psychology, and sexology
counseling, and will refer them to the required services. Referrals will be made to
supportive care services available at their healthcare institution.
Arm group label:
In-person patient navigation and supportive care referrals
Summary:
The goal of this prospective 1:1 randomized controlled trial is to evaluate if an online
patient navigation program, designed to identify targeted supportive care needs and to
facilitate referrals and web-based interventions to address these needs, can increase
patients' access to supportive care services, compared to traditional in-person patient
navigation providing referrals to in-person supportive care services
The main questions it aims to answer are:
- Does online patient navigation increase access to supportive care services by ≥30%
among patients with breast cancer?
- Which are the barriers that hinder patients' access to the supportive care
services they require?
- What is patients' level of satisfaction with online patient navigation?
Researchers will compare the online patient navigation program to traditional in-person
patient navigation providing referrals to in-person supportive care services to assess if
online patient navigation increases patients' access to supportive care services.
Participants will:
- Participate in an online or in-person patient navigation program for 4 weeks
- Answer the study surveys at baseline and 4 weeks of follow-up
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Female sex
- Age ≥18 years
- Diagnosis of non-metastatic breast cancer
- Internet access at home or in their mobile phone
- Availability to answer the study surveys
- Provision of signed informed consent
Exclusion Criteria:
- Disease recurrence
- Inability to read or write
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hospital Zambrano Hellion
Address:
City:
San Pedro Garza Garcia
Zip:
66260
Country:
Mexico
Contact:
Last name:
Cynthia Villarreal-Garza, MD, DSc
Phone:
+528110118074
Email:
cynthia.villarreal@tecsalud.mx
Contact backup:
Last name:
Fernanda Mesa-Chavez, MD, MSc
Start date:
July 1, 2025
Completion date:
February 2026
Lead sponsor:
Agency:
Medicos e Investigadores en la Lucha contra el Cancer de Mama
Agency class:
Other
Source:
Medicos e Investigadores en la Lucha contra el Cancer de Mama
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06597773
