Online Patient Navigation Program for Patients With Breast Cancer

NCT06597773 | Withdrawn

• 1 other identifier: ECA-Navegacion
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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 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

Conditions

Breast Cancer; Supportive Care in Cancer; Patient Navigation

Keywords

breast cancer; supportive care; patient navigation; online patient navigation

Outcome Measures

Primary Outcomes (1)

• Access to supportive care services

  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

Study Arms (2)

Online patient navigation and supportive care referrals

EXPERIMENTAL

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-person patient navigation and supportive care referrals

ACTIVE COMPARATOR

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

Interventions

Online patient navigation and supportive care referrals OTHER

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.

Online patient navigation and supportive care referrals

In-person patient navigation and supportive care referrals OTHER

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.

In-person patient navigation and supportive care referrals

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Disease recurrence
• Inability to read or write

Sponsors & Collaborators

• Medicos e Investigadores en la Lucha contra el Cancer de Mama: lead

Study Sites (1)

Hospital Zambrano Hellion

San Pedro Garza García, Nuevo León, 66260, Mexico

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: September 19, 2024
• Study Start: September 21, 2025
• Primary Completion: September 22, 2025
• Study Completion: September 23, 2025
• Last Updated: September 26, 2025

Record last verified: 2025-09

Locations

ME (1)