RecruitingNot ApplicableNCT06090747

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

Efecto de Una intervención Multidisciplinaria de Estilo de Vida Sobre el Exposoma de Pacientes premenopáusicas Con cáncer de Mama Estadios I-III.


Sponsor

Instituto Nacional de Cancerologia de Mexico

Enrollment

146 participants

Start Date

Mar 9, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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

Sex: FEMALEMin Age: 18 YearsMax Age: 40 Years

Inclusion Criteria4

  • 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.

Exclusion Criteria8

  • 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
  • Have cardiovascular, respiratory, or musculoskeletal diseases that impede physical activity
  • Pregnant or breastfeeding
  • Have psychiatric conditions impeding active participation in this protocol
  • Do not understand Spanish

Interventions

BEHAVIORALHybrid lifestyle educational multidisciplinary intervention.

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.

BEHAVIORALHybrid lifestyle personalized multidisciplinary intervention.

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


Locations(1)

Dr. Marlid Cruz Ramos

México, Mexico

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NCT06090747


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