About this trial
Breast cancer is the leading cause of mortality in women worldwide. Latin-American women are diagnosed at younger ages, in advanced stages, and with aggressive molecular subtypes. Lifestyle seems related to these aggressive conditions and worse outcomes. The present study seeks to evaluate the effect of a hybrid multidisciplinary intervention for implementing a healthy lifestyle to modify the personal and internal exposome of young women with breast cancer. This randomized controlled experimental study with two groups:
Group 1: Hybrid multidisciplinary lifestyle education intervention. Group 2: Individualized hybrid multidisciplinary lifestyle interventions. The multidisciplinary lifestyle intervention program includes oncology, nutrition, physiotherapy, and psychology interventions.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women diagnosed with stage I-III BC, confirmed by pathology and image at the INCAN
Candidates for multidisciplinary treatment including surgery, chemotherapy, and/or hormonal treatments.
Signed the informed consent form
Have access to a mobile phone or any electronic device with an active internet connection to receive the program information.
Disqualifiers
Patients with inflammatory cancer
Those with cardiomyopathy or ventricular dysfunction (NYHA >II), arrythmia secondary to left ventricular ejection alterations that requires medication, previous myocardial infarction, or angina pectoris in the last six months
Receiving treatment for cardiovascular or cerebrovascular disease, inflammatory bowel disease, malabsorption syndrome, rheumatoid arthritis, lupus, thyroid diseases, or Cushing syndrome
Unable to walk for at least 1 km
Trial design
Parallel
Treatments tested in this trial
Hybrid lifestyle educational multidisciplinary intervention.
BehavioralParticipants will receive a standardized educational healthy lifestyle intervention. The information will be shared via digital tools such as mail, WhatsApp, zoom workshops, educational videos, "Joven, Fuerte y Saludable" webpage, "Joven, Fuerte y Saludable" mobile app, and face-to-face educational sessions.
Hybrid lifestyle personalized multidisciplinary intervention.
BehavioralParticipants will receive a standardized educational healthy lifestyle intervention and personalized lifestyle intervention based on their clinical evaluation. Based on clinical records participants will be sent to nutritional, psychological, rehabilitation, and Mindfulness intervention. Educational and motivational strategies include digital tools such as mail, WhatsApp, zoom workshops, educational videos, the "Joven, Fuerte y Saludable" webpage, and the "Joven, Fuerte y Saludable" mobile app. And individualized follow-up through Mobile apps such as AVENA
Treatment groups
Trial outcomes
Primary outcomes
Adoption of healthy lifestyle
The patient lifestyle compliance measured by the scores of World Cancer Research Fund (WCRF) / American Institute for Cancer Research (AICR) questionnaire, SCORE ≥ 5
Changes on 24-hour reminder
Evaluate the changes on daily nutritional intake (total energy, carbohydrate, protein and, lipids grams)
Education and Motivational effectiveness of digital tools.
To evaluate the motivational and educational effect of a personalized follow-up by phone, Zoom, WhatsApp, or social networks (number of views in videos, number of Zoom sessions, number o WA calls).
Physical Activity changes
Evaluate the changes on physical activitiy by International Physical Activity Questionnaire (IPAQ) score (high: 1500 to 3000 METS per/week; moderate: 600 MET per/week.
Secondary outcomes
Improvement of quality of life parameters with lifestyle intervention- QLQ-C30
Effect of lifestyle intervention on quality of life measured by European Organization of Research and Treatment of Cancer Quality of Life Questionnarie (QLQ-C30)
Barriers and challenges to implement the lifestyle intervention - CFIR
To identify the barriers and challenges for the implementation of the healthy lifestyle intervention. CFIR (Consolidated Framework for Implementation Research) - qualitative evaluation
Barriers and challenges to implement the lifestyle intervention - RE-AIM
To identify the barriers and challenges for the implementation of the healthy lifestyle intervention. RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance)
Improvement of quality of life parameters with lifestyle intervention- QLQ-BR23
Effect of lifestyle intervention on quality of life measured by Quality of Life Questionnarie Breast Cancer (QLQ-BR23) - Sympton scale score.
Sponsors and contacts
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Instituto Nacional de Cancerologia de Mexico
Lead sponsor
Anahuac University
Collaborator
Tecnologico de Monterrey
Collaborator
Instituto Nacional de Rehabilitacion
Collaborator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Collaborator
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Collaborator