Online Patient Navigation Program for Patients With Breast Cancer

September 22, 2025 updated by: Fernanda Mesa-Chavez, Medicos e Investigadores en la Lucha contra el Cancer de Mama

Online Patient Navigation Program for Timely Access to Supportive Care Services Among Patients With Breast Cancer

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 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?

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Nuevo León
      • San Pedro Garza García, Nuevo León, Mexico, 66260
        • Hospital Zambrano Hellion

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Online patient navigation and supportive care referrals

The intervention group will participate in an online patient navigation program designed to identify patients' nutrition, psychology, and sexology counseling needs, and to facilitate referrals and web-based systematic interventions to address these supportive care needs.

Participants in this group will complete the study surveys at baseline (T1) and 4 weeks (T2) of follow-up.
Other: Online patient navigation and supportive care referrals
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.
Active Comparator: In-person patient navigation and supportive care referrals

The control group will participate in an in-person patient navigation program designed to identify patients' nutrition, psychology, and sexology counseling needs, and to facilitate referrals to in-person supportive care services.

Participants in this group will complete the study surveys at baseline (T1) and 4 weeks (T2) of follow-up.
Other: In-person patient navigation and supportive care referrals
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Access to supportive care services
Time Frame: 4 weeks
Participants' rate of attendance to each of the supportive care services in study will be evaluated through a survey at 4 weeks of follow-up, which will assess each group's access to the recommended services, barriers encountered, and satisfaction with the navigation program.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medicos e Investigadores en la Lucha contra el Cancer de Mama

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2025

Primary Completion (Estimated)

September 22, 2025

Study Completion (Actual)

September 23, 2025

Study Registration Dates

First Submitted

September 12, 2024

First Submitted That Met QC Criteria

September 12, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

September 26, 2025

Last Update Submitted That Met QC Criteria

September 22, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECA-Navegacion

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on Online patient navigation and supportive care referrals

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Georgia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe