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

October 13, 2023 updated by: Marlid Cruz Ramos, Instituto Nacional de Cancerologia de Mexico

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Breast cancer (BC) is a leading cause of death in women worldwide, especially in Latin America, where patients often present with advanced stages of aggressive subtypes of BC at a younger age. The risk of BC depends on various factors, including hormone replacement therapy history, reproductive history, alcohol or tobacco consumption, physical activity, and dietary habits, collectively called exposome. Exposome refers to the exposure to environmental influences and biological responses throughout a person's life from the prenatal stage. It can be influenced by the environment, diet, behavior, and endogenous processes.

External exposome refers to environmental factors such as mental stress, climate, and lifestyle. In contrast, internal exposome are changes within an organism, such as increased stress hormones, inflammatory cytokines, and oxidative stress. Constant exposure to environmental factors, such as an unhealthy lifestyle, can cause cellular damage and contribute to the growth and evolution of tumors. Once cellular damage occurs, internal exposome promotes changes that create a harmful environment, favoring cancer cells to acquire coping mechanisms for stress and drugs, leading to resistance to oncological treatments.

Obesity is part of the personal exposome and can impact the internal exposome, potentially affecting BC patients. A significant percentage of patients diagnosed with BC (70.9%) are overweight or obese at the time of diagnosis. This weight gain usually occurs during systemic treatment, with 25% of patients gaining weight within six months, 32% between 6-12 months, and 20% between 12-18 months after diagnosis. Young women with breast cancer (YWBC) also experience an increase in weight since the initiation of oncological treatment and up to the second year of diagnosis (from 39% at baseline to 46% in two years), highlighting the importance of evaluating the implications of weight gain and whether early intervention would help control the risk factors mentioned earlier. Obesity may also be associated with worse disease-free and overall survival.

Weight gain in patients with BC is often associated with several factors, including systemic treatment, diagnosis at a young age, and lifestyle changes resulting from the disease or treatment. However, reduced physical activity is the primary mechanism underlying weight gain. The combination of chemotherapy and endocrine therapy is linked to higher weight gain, especially in patients who are premenopausal (an increase of up to 24 kg). In contrast, postmenopausal women tend to lose weight.

BC patients have reported experiencing physical symptoms and psychological distress, which can negatively impact their quality of life (QoL). These symptoms can affect their physical functioning, psychological well-being, and social support levels. YWBC is a vulnerable population with specific concerns such as fertility, self-image, QoL, sexuality, and personal goals and experience high anxiety and depression. Maintaining a healthy lifestyle can improve QoL and lead to better prognoses and lower mortality rates. For example, exercise can reduce breast cancer-related death risk by 30% and all-cause death risk by 41%. Patients undergoing oncology treatment face various nutritional challenges that differ based on the type and stage of cancer, and the treatments may worsen these challenges. Early nutritional screening and interventions are crucial in the cancer population, as emphasized in the clinical guidelines (ASPEN/ESPEN).

The Instituto Nacional de Cancerología (INCAN) in Mexico City offers a program called "Joven & Fuerte" for young women diagnosed with BC. However, the attention was not systematic, and it was difficult to measure the benefits of the intervention. So, the present study proposes a psychological intervention, side effect management, physical activity, sleep hygiene, and psychological strategies, with onsite and remote interventions to improve patient adherence and ensure timely attention. The study aims to evaluate the impact of early intervention on metabolic control in newly diagnosed BC patients, their QoL, and clinical outcomes.

METHODS 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, whereas the second group will receive an individualized hybrid multidisciplinary lifestyle intervention.

Patients will be recruited through an active program at the INCAN, where potential candidates will be identified and invited by the navigator at the program "Joven & Fuerte." After they sign the informed consent form (ICF), patients will be assigned into one of the two groups:

Group 1: Hybrid multidisciplinary lifestyle education intervention. Group 2: Individualized hybrid multidisciplinary lifestyle interventions. The initial proposal was a randomized assignment to each group; however, the pilot study revealed challenges for patients who lived far from the hospital, in other states or had personal obligations such as family or work. Therefore, the randomization process was adapted to meet the patient's needs. The intervention aims to facilitate patients' adherence and follow-up with healthcare providers. Additionally, patient preferences were considered when assigning them to a group.

Objectives.

To assess the ability of a personalized lifestyle intervention to support breast cancer patients undergoing active treatment to maintain or obtain a healthy lifestyle.

To evaluate adopting a healthy lifestyle, validated questionnaires will be applied to assess lifestyle components such as level of physical activity, sleep hygiene, and emotional distress (baseline, during, and after treatment).

To evaluate changes in internal exposome parameters such as body composition, biochemical, inflammatory, and metabolomic indicators will be measured.

To evaluate the effectiveness of a virtual educational program to support breast cancer patients in active treatment to maintain or obtain a healthy personal exposome and its usefulness in patients who live in remote locations or cannot attend a face-to-face consultation.

To evaluate the motivational and educational effect of a personalized follow-up by phone, Zoom, WhatsApp, or social networks.

To evaluate the implementation's effect on participants' quality of life. To evaluate the barriers and challenges to implementing the healthy life intervention.

The proposed indicators will make it possible to measure the effect of the proposed intervention on the exposome of the patients, as well as adherence to the intervention, through attendance at consultations and changes in lifestyle using validated questionnaires. Among the interventions, an individualized hybrid format is proposed, both with face-to-face consultations, as well as remote follow-up through telephone calls, video calls, or material sent through digital platforms, which will benefit patients who are far from the institute or who they have difficulties to attend due to travel times, work schedules; which translates into greater adherence to the intervention and positive changes in the lifestyle of patients. Finally, it is proposed to produce an educational manual and other printed or video support materials for patients, allowing the program to be replicated in other centers with similar needs in Mexico and Latin America. Additionally, the present study intends to use the variables obtained: the clinical, anthropometric, biochemical, inflammatory profile, and metabolites identified as possible biomarkers to develop a predictor algorithm for the deterioration of quality of life in patients.

Study Type

Interventional

Enrollment (Estimated)

146

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Mexico
      • México, Mexico, 14370
        • Recruiting
        • Dr. Marlid Cruz Ramos
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Evaluate the effect of hybrid educational intervention in Lifestyle behavior.
Group 1: hybrid educational intervention
Behavioral: Hybrid 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.
Experimental: Evaluate the effect of hybrid personalized intervention in Lifestyle behavior
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adoption of healthy lifestyle
Time Frame: Baseline evaluation and final evaluation (18 months).
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
Time Frame: Baseline, 3, 6, 12 and 18 months.
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.
Time Frame: 3, 6, 12 and 18 months.
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
Time Frame: Baseline, 3, 6,12 and 18 months.
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
Time Frame: Baseline, 3, 6,12 and 18 months.
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
Time Frame: Baseline, 3, 6,12 and 18 months.
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
Time Frame: Baseline, 3, 6,12 and 18 months.
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
Time Frame: Baseline, 3, 6,12 and 18 months.
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
Time Frame: Baseline, 3, 6,12 and 18 months.

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
Time Frame: Baseline, 3, 6,12 and 18 months.

To evaluate the effect of lifestyle intervention on biochemical parameters:

Cytokines level
Baseline, 3, 6,12 and 18 months.
Anthropometric measurements - Body weight
Time Frame: Baseline, 3, 6,12 and 18 months.

Changes in:

Body weight (kg)
Baseline, 3, 6,12 and 18 months.
Minfulness evaluation - Disposition to attention awareness
Time Frame: Baseline, 3, 6,12 and 18 months.
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
Time Frame: Baseline, 3, 6,12 and 18 months.
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
Time Frame: Baseline, 3, 6,12 and 18 months.

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
Time Frame: Baseline, 3, 6,12 and 18 months.

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
Time Frame: Baseline, 3, 6,12 and 18 months.

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
Time Frame: Baseline, 3, 6,12 and 18 months.

Changes in:

Waist circumference (cm)
Baseline, 3, 6,12 and 18 months.
Anthropometric measurements - Waist to hip ratio
Time Frame: Baseline, 3, 6,12 and 18 months.

Changes in:

Waist to hip ratio (<0.8)
Baseline, 3, 6,12 and 18 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of quality of life parameters with lifestyle intervention- QLQ-C30
Time Frame: Baseline, 3, 6 ,12 and 18 months.
Effect of lifestyle intervention on quality of life measured by European Organization of Research and Treatment of Cancer Quality of Life Questionnarie (QLQ-C30)
Baseline, 3, 6 ,12 and 18 months.
Barriers and challenges to implement the lifestyle intervention - CFIR
Time Frame: 3, 6, 12 and 18 months.

To identify the barriers and challenges for the implementation of the healthy lifestyle intervention.

CFIR (Consolidated Framework for Implementation Research) - qualitative evaluation
3, 6, 12 and 18 months.
Barriers and challenges to implement the lifestyle intervention - RE-AIM
Time Frame: 3, 6, 12 and 18 months.

To identify the barriers and challenges for the implementation of the healthy lifestyle intervention.

RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance)
3, 6, 12 and 18 months.
Improvement of quality of life parameters with lifestyle intervention- QLQ-BR23
Time Frame: Baseline, 3, 6 ,12 and 18 months.
Effect of lifestyle intervention on quality of life measured by Quality of Life Questionnarie Breast Cancer (QLQ-BR23) - Sympton scale score.
Baseline, 3, 6 ,12 and 18 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Cancerologia de Mexico

Collaborators

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Anahuac University
Instituto Nacional de Rehabilitacion
Tecnologico de Monterrey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

September 7, 2023

First Submitted That Met QC Criteria

October 13, 2023

First Posted (Actual)

October 19, 2023

Study Record Updates

Last Update Posted (Actual)

October 19, 2023

Last Update Submitted That Met QC Criteria

October 13, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 023-005-OMI(CEI-05022)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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