Trial Title:
Improving Lifestyle Behavior by "Joven, Fuerte y Saludable" Multidisciplinary Program.
NCT ID:
NCT06090747
Condition:
Breast Neoplasm
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Multidisciplinary
Intervention
Lifestyle
Breast Cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
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).
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Hybrid lifestyle educational multidisciplinary intervention.
Description:
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.
Arm group label:
Evaluate the effect of hybrid educational intervention in Lifestyle behavior.
Intervention type:
Behavioral
Intervention name:
Hybrid lifestyle personalized multidisciplinary intervention.
Description:
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
Arm group label:
Evaluate the effect of hybrid personalized intervention in Lifestyle behavior
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.
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.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
40 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Dr. Marlid Cruz Ramos
Address:
City:
México
Zip:
14370
Country:
Mexico
Status:
Recruiting
Contact:
Last name:
Marlid Cruz Ramos, PhD
Phone:
+525516900151
Email:
marlid.cruz@gmail.com
Start date:
March 9, 2023
Completion date:
December 31, 2028
Lead sponsor:
Agency:
Instituto Nacional de Cancerologia de Mexico
Agency class:
Other
Collaborator:
Agency:
Anahuac University
Agency class:
Other
Collaborator:
Agency:
Tecnologico de Monterrey
Agency class:
Other
Collaborator:
Agency:
Instituto Nacional de Rehabilitacion
Agency class:
Other
Collaborator:
Agency:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Agency class:
Other
Collaborator:
Agency:
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Agency class:
Other
Source:
Instituto Nacional de Cancerologia de Mexico
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06090747
