Online Patient Navigation Program for Patients With Breast Cancer

NCT ID: NCT06597773

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-21
• Study Completion Date: 2025-09-23

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Online patient navigation and supportive care referrals

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

In-person patient navigation and supportive care referrals

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Medicos e Investigadores en la Lucha contra el Cancer de Mama

OTHER

Sponsor Role: lead

Responsible Party

Fernanda Mesa-Chavez

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Zambrano Hellion

San Pedro Garza García, Nuevo León, Mexico

Countries

Mexico

Other Identifiers

ECA-Navegacion

Identifier Type: -

Identifier Source: org_study_id