Improving Lifestyle Behavior by "Joven, Fuerte y Saludable" Multidisciplinary Program.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorInstituto Nacional de Cancerologia de Mexico

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Hybrid lifestyle educational multidisciplinary intervention.

    Behavioral

    Participants 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.

    Behavioral

    Participants 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

146 Participants
are divided into 2 treatment groups
Group A: Evaluate the effect of hybrid educational intervention in Lifestyle behavior.Active comparator 1 intervention
Group B: Evaluate the effect of hybrid personalized intervention in Lifestyle behaviorExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Baseline evaluation and final evaluation (18 months).
2

Changes on 24-hour reminder

Evaluate the changes on daily nutritional intake (total energy, carbohydrate, protein and, lipids grams)

Time frame
Baseline, 3, 6, 12 and 18 months.
3

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).

Time frame
3, 6, 12 and 18 months.
4

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.

Time frame
Baseline, 3, 6,12 and 18 months.

Secondary outcomes

1

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)

Time frame
Baseline, 3, 6 ,12 and 18 months.
2

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

Time frame
3, 6, 12 and 18 months.
3

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)

Time frame
3, 6, 12 and 18 months.
4

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.

Time frame
Baseline, 3, 6 ,12 and 18 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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