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

NCT06090747 | Recruiting DMC

• 1 other identifier: 023-005-OMI(CEI-05022)
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Neoplasm

Keywords

Multidisciplinary; Intervention; Lifestyle; Breast Cancer

Outcome Measures

Primary Outcomes (18)

• 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

  Baseline evaluation and final evaluation (18 months).

• Changes on 24-hour reminder

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

  Baseline, 3, 6, 12 and 18 months.

• 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).

  3, 6, 12 and 18 months.

• 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.

  Baseline, 3, 6,12 and 18 months.

• Quality of sleep changes

  Evaluate the quality of sleep changes by Pittsburgh Sleep Quality Index (PSQI). Total Score 0 to 21. Score 0 (No sleep difficulty); Score 1 to7 (mild sleep difficulty); Score 8-14 (moderate sleep dificulty); 15-21 (severe sleep difficulty).

  Baseline, 3, 6,12 and 18 months.

• Depression risk evaluation

  Patient Health Questionnaire (PHQ-9) 1-4 Minimal depression 5-9 Mild depression 10-14 Moderate depression 15-19 Moderately severe depression 20-27 Severe depression

  Baseline, 3, 6,12 and 18 months.

• Anxiety risk evaluation

  Generalized Anxiety Disorder Assessment (GAD-7) 0-4: minimal anxiety 5-9: mild anxiety 10-14: moderate anxiety 15-21: severe anxiety

  Baseline, 3, 6,12 and 18 months.

• Minfulness evaluation - How having a concentrated mind affects on daily life

  Five Facet Mindfulness Questionnaire (FFMQ) 1-2: Lack of concentrated mind 3: Intermediate attention awareness 4-5: Advance attention awareness

  Baseline, 3, 6,12 and 18 months.

• Body composition - Body fat

  To evaluate the Effect of lifestyle intervention on: Body fat percentage (acceptable fat percentage \<31%)

  Baseline, 3, 6,12 and 18 months.

• Biochemical parameters - Inflammatory cytokines

  To evaluate the effect of lifestyle intervention on biochemical parameters: Cytokines level

  Baseline, 3, 6,12 and 18 months.

• Anthropometric measurements - Body weight

  Changes in: Body weight (kg)

  Baseline, 3, 6,12 and 18 months.

• Minfulness evaluation - Disposition to attention awareness

  Mindful Attention Awareness Scale (MAAS) 1-2: Lack of attention awareness 3: Intermediate attention awareness 4-5: Advance attention awareness 6: Overvalued (questionnaire was notanswered honestly)

  Baseline, 3, 6,12 and 18 months.

• Minfulness evaluation - Disposition to mindfulness

  Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) 1-2: Lack of disposition 3: Intermediate disposition 4: Advance into mindfulness

  Baseline, 3, 6,12 and 18 months.

• Body composition - Muscle

  To evaluate the Effect of lifestyle intervention on: Muscle (muscle mass in kg and muscle mass index ≤6.42 kg/m2)

  Baseline, 3, 6,12 and 18 months.

• Biochemical parameters - Glucose

  To evaluate the effect of lifestyle intervention on biochemical parameters: Blood glucose \<135mg/dL

  Baseline, 3, 6,12 and 18 months.

• Biochemical parameters - Lipid profile

  To evaluate the effect of lifestyle intervention on biochemical parameters: LDL\<100mg/dL, HDL \>40mg/dL and triglycerides \<150mg/dL)

  Baseline, 3, 6,12 and 18 months.

• Anthropometric measurements - Waist circumference

  Changes in: Waist circumference (cm)

  Baseline, 3, 6,12 and 18 months.

• Anthropometric measurements - Waist to hip ratio

  Changes in: Waist to hip ratio (\<0.8)

  Baseline, 3, 6,12 and 18 months.

Secondary Outcomes (4)

• Improvement of quality of life parameters with lifestyle intervention- QLQ-C30

  Baseline, 3, 6 ,12 and 18 months.

• Barriers and challenges to implement the lifestyle intervention - CFIR

  3, 6, 12 and 18 months.

• Barriers and challenges to implement the lifestyle intervention - RE-AIM

  3, 6, 12 and 18 months.

• Improvement of quality of life parameters with lifestyle intervention- QLQ-BR23

  Baseline, 3, 6 ,12 and 18 months.

Study Arms (2)

Evaluate the effect of hybrid educational intervention in Lifestyle behavior.

ACTIVE COMPARATOR

Group 1: hybrid educational intervention

Behavioral: Hybrid lifestyle educational multidisciplinary intervention.

Evaluate the effect of hybrid personalized intervention in Lifestyle behavior

EXPERIMENTAL

Group 2: hybrid personalized lifestyle intervention delivered by a multidisciplinary team of specialists in oncology, nutrition, psychology, rehabilitation and mindfulness.

Behavioral: Hybrid lifestyle personalized multidisciplinary intervention.

Interventions

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.

Evaluate the effect of hybrid educational intervention in Lifestyle behavior.

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

Evaluate the effect of hybrid personalized intervention in Lifestyle behavior

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Nacional de Cancerologia de Mexico: lead
• 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

Study Sites (1)

Dr. Marlid Cruz Ramos

México, 14370, Mexico

RECRUITING

Related Publications (40)

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MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Marlid Cruz Ramos, PhD

CONTACT

+525556280400; marlid.cruz@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: A controlled trial design was adopted in which patients were assigned to two intervention groups according to the nutritional, psychological, or rehabilitation risk at baseline or according to their geographical localization. The first group will receive a hybrid multidisciplinary lifestyle education intervention (control), whereas the second group will receive an individualized hybrid multidisciplinary lifestyle intervention. The study aims to evaluate the effect of both interventions on the internal exposome of young patients with breast cancer and their effect on quality of life. To do this, changes over time in biochemical, inflammatory, and metabolomic indicators will be measured, and validated questionnaires will be applied to assess lifestyle components such as level of physical activity, sleep hygiene, emotional distress, and quality of life (so baseline, during and after treatment).

Study Record Dates

• First Submitted: September 7, 2023
• First Posted: October 19, 2023
• Study Start: March 9, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: October 19, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)