Breast Cancer, Patient Navigation, Supportive Care in Cancer
Conditions
Keywords
breast cancer, supportive care, patient navigation, online patient navigation
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
Interventions
OTHEROnline 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.
OTHERIn-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.
Sponsors
Medicos e Investigadores en la Lucha contra el Cancer de Mama
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Access to supportive care services | 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. |
Countries
Mexico
Outcome results
None listed