Efecto de Una intervención Multidisciplinaria de Estilo de Vida Sobre el Exposoma de Pacientes premenopáusicas Con cáncer de Mama Estadios I-III.
Phase: NA
Conditions: Breast Neoplasm
Sponsor: Instituto Nacional de Cancerologia de Mexico

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ClinicalTrials.gov  
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Protocol Registration and Results System (PRS)  
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ClinicalTrials.gov ID: [Not yet assigned]  
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Last review date: October 13th, 2023.  
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Study Identification Unique Protocol ID: 023-005-OMI(CEI-05022)  
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Brief Title: Improving Lifestyle Behavior by "Joven, Fuerte y Saludable" 
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Multidisciplinary Program. Official Title: Efecto de Una intervención Multidisciplinaria 
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de Estilo de Vida Sobre el Exposoma de Pacientes premenopáusicas Con cáncer 
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de Mama Estadios I-III. 
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Title: Improving Lifestyle Behavior by "Joven, Fuerte y Saludable" Multidisciplinary 
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Program. Official Title: Efecto de Una intervención Multidisciplinaria de Estilo de Vida 
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Sobre el Exposoma de Pacientes premenopáusicas Con cáncer de Mama Estadios 
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I-III. 
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Abstract 
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Background. Breast cancer (BC) is the leading cause of cancer-related death and 
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disability in young women. Patients with BC experience physical symptoms and 
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psychosocial distress that adversely affect their quality of life (QoL), physical 
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functioning, and psychological well-being. “Joven & Fuerte'' is a navigation program 
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for young women with BC at the National Cancer Institute in Mexico City. The 
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program proposes an hybrid model (face-to-face and virtual) to support patients on 
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aspects such as oncology, nutrition literacy, and psychology with mindfulness. 
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Methods. The study was initially planned as a randomized controlled trial to ensure 
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accurate results. However, during the pilot study, it was adapted to meet the specific 
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needs of patients such as oncology consultations and in consideration of living 
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arrangements. Two groups will be compared: one receives hybrid education and the 
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other, a hybrid education and personalized intervention. Patients who agreed for the 
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face-to-face sessions were assigned to the personalized interventions group, and 
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others, to the hybrid education group. The intervention group receives an in-person 
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consultation to evaluate their physical measurements and an interdisciplinary 
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assessment by experts. Patients can ask for virtual assistance through Zoom and 
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WhatsApp in case of any issues during the intervention. In addition, educational 
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materials such as healthy lifestyle guides and videos can be accessed through 
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Facebook and YouTube groups upon request. To ensure the comprehension of the 
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material, follow-up sessions are conducted through phone calls, video calls, or on-
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site visits. Validated questionnaires will assess lifestyle habits, QoL status, and 
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levels of distress, anxiety, and depression. 
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What is already known on this topic 
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● Breast cancer and its treatment impacts the lifestyle and quality of life of 
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patients. 
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● Improvement in nutrition, lifestyle, and psychological wellbeing positively 
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impacts the prognosis of breast cancer and quality of life or survivors.  
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What this study adds 
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● Provides interventions for patients living far from a hospital. 
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● Evaluates the health advantages of educational and personalized 
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interventions.  
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● Examines how lifestyle changes affect the quality of life, mental health, and 
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physical functioning of patients with breast cancer receiving cancer treatment. 
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How this study might affect research, practice, or policy 
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● This hybrid approach is both viable and economical for public institutions.  
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● The findings of this study will reveal the effects of these interventions and their 
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potential benefits to patients. 
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INTRODUCTION 
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Breast cancer (BC) is a leading cause of death in women worldwide, especially in 
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Latin America, where patients often present with advanced stages of aggressive 
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subtypes of BC at a younger age (1). The risk of BC depends on various factors, 
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including hormone replacement therapy history, reproductive history, alcohol or 
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tobacco consumption, physical activity, and dietary habits, that are collectively called 
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exposome (2). Exposome refers to the exposure to environmental influences and 
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biological responses throughout a person's life from the prenatal stage. It can be 
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influenced by the environment, diet, behavior, and endogenous processes (3).  
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External exposome refers to environmental factors such as mental stress, climate, 
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and lifestyle. In contrast, internal exposome are changes within an organism such 
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as increased stress hormones, inflammatory cytokines, and oxidative stress (4). 
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Constant exposure to environmental factors, such as an unhealthy lifestyle, can 
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cause cellular damage and contribute to the growth and evolution of tumors. Once 
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cellular damage occurs, internal exposome promotes changes that create a harmful 
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environment, favoring cancer cells to acquire mechanisms to cope with stress and 
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drugs, leading to a resistance to oncological treatments (5). 
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Obesity is part of the personal exposome and can impact the internal exposome, 
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potentially affecting BC patients. A significant percentage of patients diagnosed with 
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BC (70.9%) are overweight or obese at the time of diagnosis (6). This weight gain 
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usually occurs during systemic treatment, with 25% of patients gaining weight within 
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six months, 32% between 6-12 months, and 20% between 12-18 months after 
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diagnosis (7). Young women with breast cancer (YWBC) also experience and 
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increase in weight since the initiation of oncological treatment and up to the second 
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year of diagnosis (from 39% at baseline to 46% in two years), highlighting the 
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importance of evaluating the implications of weight gain and whether early 
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intervention would help control the risk factors mentioned earlier (8). Obesity may 
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also be associated with worse disease-free and overall survival (9). 
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Weight gain in patients with BC is often associated with several factors, including 
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systemic treatment, diagnosis at a young age, and lifestyle changes resulting from 
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the disease or treatment. However, the primary mechanism underlying weight gain 
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is reduced physical activity (10). The combination of chemotherapy and endocrine 
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therapy is linked to higher weight gain, especially in patients who are premenopausal 
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(a gain of up to 24 kg). In contrast, those who are postmenopausal tend to lose 
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weight (11). 
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BC patients have reported experiencing physical symptoms and psychological 
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distress, which can negatively impact their quality of life (QoL). These symptoms can 
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affect their physical functioning, psychological well-being, and social support levels 
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(12). Particularly, YWBC is a vulnerable population with specific concerns such as 
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fertility, self-image, QoL, sexuality, and personal goals (13) and experience high 
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anxiety and depression (14). Maintaining a healthy lifestyle can improve QoL and 
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lead to better prognoses and lower mortality rates (15). For example, exercise can 
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reduce breast cancer-related death risk by 30% and all-cause death risk by 41% 
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(16). Patients undergoing oncology treatment face various nutritional challenges that 
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differ based on the type and stage of cancer, and the treatments may worsen these 
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challenges. Early nutritional screening and interventions are crucial in the cancer 
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population, as emphasized in the clinical guidelines (ASPEN/ESPEN) (17). 
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The Instituto Nacional de Cancerología (INCAN) in Mexico City offers a program 
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called "Joven & Fuerte" for young women diagnosed with BC. However, the attention 
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was not systematic and it was difficult to measure the benefits of the intervention. So 
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the present study proposes a psychological intervention, side effect management, 
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physical activity, sleep hygiene, and psychological strategies, with onsite and remote 
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interventions to improve patient adherence and ensure timely attention. The study 
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aims to evaluate the impact of early intervention on metabolic control in newly 
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diagnosed BC patients, their QoL, and clinical outcomes. 
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METHODS 
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A controlled trial design was adopted in which patients were assigned to two 
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intervention groups according to the nutritional, psychological, or rehabilitation risk 
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at baseline or according to their geographical localization. The first group will receive 
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a hybrid multidisciplinary lifestyle education intervention, whereas the second group 
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will receive an individualized hybrid multidisciplinary lifestyle intervention. 
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For sample size estimation, we used internal statistics from the Mammary Tumor 
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Department at the INCAN, which has an annual average of 109 women diagnosed 
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and treated based on the selection criteria. Considering the effect on metabolic and 
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inflammatory parameters, a study by Dieli-Conwright et al. (18) was followed to 
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identify the difference in the decrease in insulin parameters by 14%. A confidence 
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level of 95% and power of 80% were considered with a control: intervention ratio of 
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1:1. Thus, a sample size of 132 patients was obtained. Considering a probable loss 
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of 10%, 146 patients were invited to participate in the study, with 73 patients per 
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group. 
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Inclusion criteria 
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● Women aged ≥18 and <40 years who were diagnosed with stage I-III BC, 
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confirmed by pathology and image at the INCAN 
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● Candidates 
for 
multidisciplinary 
treatment, 
including 
surgery, 
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chemotherapy, and/or hormonal treatments. 
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● Signed the informed consent form 
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● Have access to a mobile phone or any electronic device with an active 
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internet connection to receive the program information. 
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 Exclusion criteria 
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● Patients with inflammatory cancer 
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● Those with cardiomyopathy or ventricular dysfunction (NYHA >II), 
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arrhythmia secondary to left ventricular ejection alterations that require 
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medication, previous myocardial infarction, or angina pectoris in the last 
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six months 
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● Receiving treatment for cardiovascular or cerebrovascular disease, 
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inflammatory bowel disease, malabsorption syndrome, rheumatoid 
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arthritis, lupus, thyroid diseases, or Cushing syndrome 
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● Unable to walk for at least 1 km 
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● Have cardiovascular, respiratory, or musculoskeletal diseases that 
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impede physical activity 
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● Pregnant or breastfeeding 
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● Have psychiatric conditions impeding active participation in this protocol 
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● Do not understand Spanish 
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Selection and group assignment of the patients 
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Patients will be recruited through an active program at the INCAN, where potential 
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candidates will be identified and invited by the navigator at the program “Joven & 
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Fuerte.” After they sign the informed consent form (ICF), patients will be assigned 
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into one of the two groups: 
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Group 1: Hybrid multidisciplinary lifestyle education intervention. 
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Group 2: Individualized hybrid multidisciplinary lifestyle interventions. 
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The initial proposal was randomized assignment to each group; however, the pilot 
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study revealed challenges for patients who lived far from the hospital, in other states, 
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or had personal obligations such as family or work. Therefore, the randomization 
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process was adapted to meet the patients’ needs. The intervention aims to facilitate 
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patients' adherence and follow-up with healthcare providers. Additionally, patient 
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preferences were considered when assigning them to a group. 
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Intervention 
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The individualized hybrid multidisciplinary lifestyle intervention consists of four 
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phases. During the initial phase, (1st month), patients undergo psychological, 
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nutritional, and physical evaluations using validated questionnaires. Weekly follow-
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ups are scheduled to answer any questions and provide educational materials. 
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Psychological intervention for the management of stress, anxiety, or other sleep 
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disorders begins during this phase. Changes in diet and physical activity levels are 
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prepared based on baseline questionnaires and adjusted to their needs and 
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preferences to facilitate adherence to the intervention. Basic nutritional orientation is 
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provided covering topics such as identification of food groups using guides such as 
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"My Plate" (19) from the American Association of Diabetes, how to read nutrition 
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facts labels, and explanation on following a healthy diet, with available food groups 
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in the country. 
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In the consolidation phase, from second to sixth month, patients undergo follow-
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ups every two weeks on-site or remotely, depending on the patient's preference. 
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Follow-up was to monitor patients’ symptoms and adjust their diet and exercise 
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routines accordingly. Psychological intervention will be tailored to individual needs if 
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a patient experiences symptoms such as nausea, vomiting, diarrhea, or fatigue. This 
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phase aims to help patients become independent and manage their activities without 
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professional help. A personalized diet and exercise plan will be created for each 
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patient, considering their socioeconomic status. The local food groups available to 
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each patient are prescribed. The Avena Health application will monitor water 
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consumption, physical activity, and nutritional adherence if the patient has access.  
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The maintenance phase, from seventh to 12th  month, the patients will be followed 
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up every two months. Anthropometric measures, blood tests, and questionnaires will 
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be used to assess their progress. The objective of this phase is to reinforce the 
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recommendations of previous phases. 
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The patients undergo check-ins every three months during the follow-up phase, 
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which begins after 12 months. In the medium term, anthropometric measures and 
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questionnaires will be used to evaluate patient adherence to multidisciplinary 
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interventions. Any questions or concerns will be addressed during the checks. See 
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Figure 1. 
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Figure 1. Joven, Fuerte y Saludable, Protocol Design. 
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Components of the Multidisciplinary Individualized Intervention 
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Nutritional Intervention 
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Patients will undergo a comprehensive nutritional assessment and receive guidance 
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on maintaining a healthy diet balanced with macronutrients. Assessment of 
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symptoms that affect nutritional or metabolic status; anthropometric indicators such 
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as weight, height, waist circumference, arm circumference, waist-to-hip ratio, and 
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body composition determined by bioelectrical impedance analysis (BIA) will be 
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collected at baseline and follow-up; and biochemical parameters such as blood 
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glucose, insulin, HbA1c, total, low-density lipoprotein-cholesterol, high-density 
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lipoprotein-cholesterol, triglycerides, and c-reactive protein (CRP) will be assessed. 
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Recommendations will be tailored to the individual's needs and budget and any 
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adverse effects related to their cancer treatment, focusing on a healthy, moderately 
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hypocaloric diet (for those who are overweight, obese, or at metabolic risk) or an 
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isocaloric diet for those who are underweight, considering the individualized 
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requirements of energy, protein, carbohydrate, lipids, vitamins, and minerals. 
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Dietetic assessment measures adherence to the diet prescription through a typical 
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feeding model or 24-hour recall. Participants will meet the program nutritionist 
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according to the visit frequency described for each phase. 
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A webpage will be available with weekly modules on nutrition, and patients will be 
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invited to workshops to resolve any obstacles they encounter while implementing 
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recommendations. A virtual class would be offered if someone could not attend the 
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workshop. A workbook with educational information and a diary section will also be 
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provided, allowing patients to share their thoughts on the intervention, challenges 
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they face, and questions. 
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Physical activity intervention 
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Patients will be prescribed a customized regimen of dynamic aerobic exercise to 
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improve their physical capacity. A stress test determines maximum effort capacity 
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and identifies contraindications. The rehabilitation team will evaluate the 
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performance status of patients using the Karnofsky Index (a functional scale) and 
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Eastern Cooperative Oncology Group (ECOG). Patients receive personalized 
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treatment based on their diagnoses. In addition, they will receive a digital or physical 
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guide of exercises appropriate for their disease stage. They should perform these 
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exercises 3-5 times weekly for at least 150 minutes, including resistance training and 
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moderate-intensity aerobics. Patients with special needs, such as those with 
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lymphedema, post-surgery, or active treatment, can also undergo various exercises. 
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A healthcare professional trained in oncological rehabilitation will supervise all the 
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exercise sessions. 
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Psychological intervention 
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During the diagnosis and treatment of BC, workshops will be held in collaboration 
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with a psychology team to assess the emotional symptoms. Patients will receive 
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videos of relaxation techniques and their anxiety levels will be monitored using a 
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thermometer anxiety tool. _Patients who score more than four will complete 
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depressive and anxiety symptom questionnaires (the Patient Health Questionnaire, 
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PHQ-9 and Generalized Anxiety Disorder, GAD-7, respectively) and will be referred 
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for group or individual therapy. The number of therapy sessions will be limited to 
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eight for individual interventions and two for each multidisciplinary intervention 
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phase. The questionnaires will be administered at the beginning and at three, six, 
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nine, and 12 months. 
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Psychological interventions will involve cognitive-behavioral therapy, which will focus 
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on changing cognition and behaviors to reduce symptoms of stress, anxiety, and 
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depression. Treatment will also address the emotional discomfort caused by the 
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diagnosis and treatment and its impact on family and couple dynamics, social and 
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work life, body image, sexuality, and fertility etc. During the sessions, a clinical 
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history will be taken, with which a Clinical Map of Pathogenesis and Goal Scope Map 
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will be generated according to the Nezú and Nezú model (4). This assessment 
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allows the development of a therapy focused on the patient's needs and, to identify 
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intervention strategies for achieving specific goals, such as psychoeducation, 
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relaxation training, cognitive restructuring, problem-solving therapy, behavioral 
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activation, and assertive communication training. Patients can choose between 
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hybrid formats such as Zoom and WhatsApp and onsite sessions with specialists. 
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Mindfulness + oncologic rehabilitation intervention 
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The oncological rehabilitation and mindfulness program consists of four modalities: 
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● Group face-to-face, 
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● Individuals face-to-face 
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● Group online, and 
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● Individual online 
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 The program can be applied at different time points during patient treatment: before, 
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after, and after surgery with chemotherapy and/or radiotherapy. 
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Physical exercises include different activity levels for patients to improve their 
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flexibility, range of motion, strength, and recovery capacity; exercises included in the 
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program are aimed at working different parts of the body, combined into different 
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techniques divided into static, moving, breathing, and meditation techniques, and 
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Thai-Chi and Qi Gong, as part of the mindfulness program. The contents of the 
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program are presented in Table 1. 
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Table 1. Mindfulness and oncologic rehabilitation content 
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PROGRAM 
ADMISSION 
ONCOLOGIC 
REHABILITATION 
EXERCISES 
MOVEMENT 
TECHNIQUES 
STATIC 
TECHNIQUES 
BREATHING 
TECHNIQUES 
MEDITATION 
TECHNIQUES 
EDUCATIONAL 
MATERIAL 
Interview (E) 
Flexibility (RFi) 
Neck (C) 
Expansion 
and 
contraction 
(ECS) 
Body scan (on 
the floor) (EA) 
Conscious 
breathing 
(RCS) 
Static 
meditation 
(ME) 
Welcome to the 
program! (BVP) 
Initial 
evaluation 
(EI) 
Range of movement 
(RRM.ii) 
Upper limbs 
(MS) 
Expansion 
and 
contraction on 
the wall (ECP) 
Body scan 
(seated) (ES) 
Conscious 
breathing (5 
words) 
(RCS5) 
Static 
meditation 
(seated) 
(MES) 
Benefits of 
oncologic 
rehabilitation 
(BFRO) 

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Questionnaire 
application 
(AC) 
Strength (Rfza. III) 
Lower limbs 
(MI) 
21 movements 
(21M) 
Internal 
circulation 
channel (CIC) 
Breathing 
awareness 
(chest, costal, 
abdominal) 
(RAWS) 
Lay down 
meditation 
(MA) 
Benefits of 
mindfulness 
(BFAP) 
Postural 
hygiene (HP) 
Recovery (RR.IV) 
Legs (P) 
Tai Chi’s 13 
movements 
(13M) 
  
Abdominal 
breathing (RA) 
Walking 
meditation 
(MC) 
Stress 
consequences 
(CSCE) 
Integration of 
the program 
(IP) 
  
Thorax (T) 
5 animals (Qi 
Gong) (5A) 
  
Breath count 
(CR) 
Moving 
meditation 
(MCM) 
 Cortisol (CZ) 
Psychological 
intervention 
(IPS) 
  
Hip (H) 
  
  
  
  
Sixth sense (SS) 
  
  
  
  
  
  
  
Nutrition (NT) 
*Codes used in this intervention are marked in bold and in parentheses. 
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Finally, sessions will be completed by ensuring that the patients are aware of the 
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importance of how stress impacts health, reminding them that specific at-home 
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exercise techniques could improve their physical condition. 
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Educative intervention 
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Psychologic and mindfulness educative intervention 
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Virtual educational intervention was adjusted to STREAM intervention for BC after 
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adapting it for our population (20). Based on our experience with the Joven & Fuerte 
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program this intervention with continue for 10 weeks, from the beginning of the 
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diagnosis, which, is when the patient requires understanding and assimilating their 
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diagnosis and the life changes that cancer treatments will represent, as well as adapt 
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to the institution. This intervention intends to manage the emotional stress of this 
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phase in collaboration with the psychology and mindfulness team. 
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Questionnaires will be administered to evaluate QoL (QLQ-C30 and QLQ-BR23) at 
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the baseline and at three, six, 12, and 18 months, and healthy lifestyle (WCFR/AICR) 
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at the beginning and end of the intervention in both groups. 
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While these activities are performed, patients will participate in a mindfulness 
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workshop for 10 weeks, which includes breathing counting techniques (Zazen), 
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guided meditations (five words of self-composure), meditation exercises with static 
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movement (BaDuanJin), conscious walking (Kinjun), body scan, energy 
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concentration work and physical movement (five healing animals), moving 
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meditation (TaiChi), and yoga. All of these techniques are intended to be tools for 
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the patient to deal with the stress she faces during her BC diagnosis. 
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Healthy lifestyle educative intervention 
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The healthy lifestyle education intervention was adapted from the Diabetes 
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Prevention Program (DPP)(21) funded by the National Institute of Diabetes and 
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Digestive and Kidney Diseases (NIDDK) and has been used in BC studies, such as 
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SUCCESS (22), MEDEA (23), and PASAPAS (24). This educational material is 
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planned to be given to all intervention groups. Every week, in a hybrid format, 
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patients will receive a WhatsApp or, through the Facebook group, the written 
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information, video, and/or audio of the subjects included in the program. Additionally, 
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patients will receive a manual with a weekly description of the topic to be discussed 
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and the activities they must carry out that week in a way that the patient will have 
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the whole week to carry out her activities; on Friday, a session will be opened both 
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on Zoom or WhatsApp, or in the case of patients who can physically go to the 
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institute in person. The expert will also be available so that the patient can share her 
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doubts and difficulties faced during the week. 
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On Table 2, educational subjects reviewed on every intervention phase are 
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described. 
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Intervention phase 
Follow-up 
Week 
Title 
Content 
Intensive phase: weekly 
follow-up 
1 
1 
Welcome to the program 
Introduction 
2 
2 
Caloric balance 
Caloric restriction 
3 
3 
Type of fatty acids 
Caloric restriction 
4 
4 
Reducing calories, 
controlling portions 
Caloric restriction 

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5 
5 
Muscular movement 
Physical activity 
6 
6 
Working with your 
surroundings 
Behavioral support 
7 
7 
Problem-solving 
Behavioral support 
8 
8 
Being active: a way of living 
Physical activity 
9 
9 
Healthy eating 
Caloric restriction 
10 
10 
Healthy eating and breast 
cancer 
Breast cancer and 
nutrition 
11 
11 
Preparing a better breakfast, 
lunch, and dinner 
Caloric restriction and 
behavioral support 
12 
12 
Progress review 
Recap and evaluation 
Consolidation phase: 
two-week follow-up 
13 
14 
Answering negative thoughts 
Behavioral support 
14 
16 
The slope in changing to a 
healthy lifestyle 
Behavioral support 
15 
18 
Intensifying physical activity 
Physical activity 
16 
20 
10 ways to control hunger 
Behavioral support 
17 
22 
What to eat on holidays 
Behavioral support 
18 
24 
Making balance and 
celebrating success 
Recap and evaluation 
19 
28 
How to stay motivated 
Behavioral support 

13 
 
Maintenance phase: 
monthly follow-up 
20 
32 
Recovering from excess 
eating 
Behavioral support 
21 
36 
Weight loss review 
Caloric restriction 
22 
40 
How to adapt to long-lasting 
success 
Behavioral support 
23 
44 
Preparing for what’s yet to 
come 
Recap and evaluation 
24 
48 
Congratulations! You 
finished the program! 
Recap and evaluation 
Table 2. Intervention phases adapted from the diabetes education program (DPP) 
314 
Barriers and facilitators for the multidisciplinary program implementation 
315 
As this program is being implemented for the first time and with the aim of enhancing 
316 
patient care, the assessment of barriers will be  carried out through questionnaires 
317 
administered to both program staff and enrolled patients. The purpose is to identify 
318 
the barriers faced by each party, thereby enabling the provision of solutions 
319 
alongside the interventions. The questionnaire design was based on the CFIR/RE-
320 
AIM framework, a tool used to assess the success of program implementation (25, 
321 
26).  
322 
Data analysis 
323 
Descriptive statistics will be performed for the clinical and demographic data. 
324 
Inferential comparisons will be made by calculating the relative risk with 95% 
325 
confidence intervals. To compare the effect between groups, a statistical comparison 
326 
with the Kolmogorov-Smirnov test will be performed, and depending on the 
327 
distribution of data, parametric (normal distribution) or non-parametric (non-normal 
328 
distribution) tests will be applied. To evaluate the differences between groups, 
329 
Student’s T test for related groups or the Mann-Whitney test will be used, while for 
330 
the analysis of repeated samples, analysis of variance (ANOVA) will be used for 
331 
three or more variables, depending on the nature of the data. 
332 
Chi-square and Fisher’s tests will be used to compare categorical variables, and the 
333 
alpha value will be set to 0.05. Bivariate analysis will be performed to identify 
334 
differences between groups and associations with survival concerning the measured 
335 

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clinical variables and biomarkers. To analyze the existing correlation with the clinical 
336 
variables, Pearson or Spearman regression with a 95% confidence interval will be 
337 
used, depending on the nature of the data distribution. To determine the associations 
338 
between independent variables, multivariate logistic regression models were used, 
339 
adjusting for the remaining clinical variables. 
340 
Discussion 
341 
Although various interventions provide nutritional and physical activity counseling, 
342 
most of them are focused on patients who have survived cancer and do not include 
343 
those who have been diagnosed recently. Emotional support is also not taken into 
344 
account. A recent meta-analysis published by Cochrane reviewed 20 studies and 
345 
involved 2028 patients with breast cancer who received interventions for weight loss. 
346 
The results showed that these interventions for survivors of breast cancer with 
347 
obesity resulted in moderate weight reduction, improved body mass index and waist 
348 
circumference, and enhanced quality of life through diet and exercise interventions 
349 
(7). It appears that a multidisciplinary approach could lead to even better results, and 
350 
probably it has to be since the diagnosis to start a mentality switch since the 
351 
beginning of the disease. 
352 
Nutritional interventions in patients with cancer ensure adequate intake of energy 
353 
and nutrients during oncological treatment, which results in an improved response 
354 
and reduced toxicity of pharmacological anti-cancer therapies. These health 
355 
changes reduce the long-term side effects of treatment and promote long-term 
356 
overall health (27). The Women’s Intervention Nutrition Study (WINS) demonstrated 
357 
the impact of nutritional intervention on the prognosis and survival of BC, with a low-
358 
fat diet promoting modest weight loss, improving metabolic biomarkers, and 
359 
positively affecting disease-free survival (28). According to lifestyle guidelines 
360 
recommended by the World Cancer Research Fund (WCRF)/American Institute for 
361 
Cancer Research (AICR), a fiber- and soy-rich diet and limited consumption of fatty 
362 
acids (especially saturated fatty acids) can improve survival after BC diagnosis (27). 
363 
According to research by Demark-Wahnefried et al., women undergoing 
364 
chemotherapy may experience a decrease in energy expenditure due to reduced 
365 
activity despite same calorie intake (29). The Health, Eating, Activity, and Lifestyle 
366 
(HEAL) study also found that patients who engaged in less exercise and physical 
367 
activity had a higher risk of weight gain. Patients who underwent chemotherapy 
368 
experienced a more significant decrease in exercise time (3.6 hours per week) than 
369 
those who underwent surgery (1.6 hours per week). Furthermore, a study showed 
370 
that all patients who underwent chemotherapy experienced amenorrhea; therefore, 
371 
changes in hormones and menopause could impact metabolism, affecting body 
372 

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composition and the waist-to-hip ratio. This can result in increased estrogen and 
373 
insulin levels (30). 
374 
Oncological rehabilitation (OR) and mindfulness stimulate specific neurovascular 
375 
terminals that activate ATP, improve bloodstream flow, and stimulate the 
376 
parasympathetic nervous system (PNS), thereby generating serotonin and 
377 
endorphins, relaxing muscles, improving digestion, and reducing insomnia. It also 
378 
prevents sarcopenia and stimulates immunoglobulins and the osteomioarticular 
379 
system (OMAS). Mindfulness provides a profound knowledge of the mind and its 
380 
discriminative processes, allowing free radicals to be dosed. Through extensive 
381 
practice, the patient learns how to regulate their attention and manages to focus on 
382 
the present, which enhances the experience itself and the exercises at hand (31). 
383 
Psychological treatments for patients with BC indicated that cognitive behavioral and 
384 
psycho-educational therapies have a significant positive impact. These therapies 
385 
improved QoL, reduced anxiety and depression, and improved mood. The study 
386 
found that treatment lasting between six and twelve weeks achieved better 
387 
psychological results than shorter or longer interventions (32). Relaxation 
388 
techniques are commonly used in mindfulness programs and psychological 
389 
interventions to alleviate symptoms of depression, anxiety, stress, and fear of 
390 
recurrence. Survivors of BC have reported improved sleep quality after practicing 
391 
these techniques. (33). Cognitive-behavioral approaches have successfully 
392 
overcome fatigue and improved sleep quality. (34). A randomized trial conducted by 
393 
Rogers et al. revealed that physical activity positively impacted overall sleep quality 
394 
compared to usual care in BC patients. (35). 
395 
Patients with BC have benefitted from virtual psychological interventions. One study 
396 
called the Web-Based Stress Management for Newly Diagnosed Patients with 
397 
Cancer (STREAM) developed an online stress management program that 
398 
significantly improved the QoL for patients in the intervention group (73.2%) 
399 
compared to the control group (59%). The Hospital Anxiety and Depression scale 
400 
(HADS) score decreased, mainly due to reduced levels of distress (20). Another 
401 
study used a web-based psychological intervention called Web-Based Self-
402 
Management for Psychological Adjustment After Primary Breast Cancer (BREATH), 
403 
which resulted in lower levels of distress (84%) and clinical deterioration (16%) for 
404 
the intervention group (36). 
405 
Conclusion 
406 
Although there have been several studies on interventions for breast cancer patients, 
407 
such as those related to nutrition, physical activity, mindfulness, or psychological 
408 
support, these interventions have typically been conducted separately and focused 
409 

16 
 
primarily on survivors. This highlights the necessity for multidisciplinary 
410 
interventions, as proposed in this study. 
411 
Acknowledgments 
412 
The authors thank the CAAI (Centro de Apoyo para la Atención Integral) of the 
413 
Instituto Nacional de Cancerología for the facilities and spaces for the 
414 
implementation of workshops for the described intervention. 
415 
Contributors  
416 
Cruz-Ramos: protocol design, principal researcher, and draft preparation. Fajardo-
417 
Espinoza: Protocol design, draft preparation, nutritional intervention design, and 
418 
implementation. Martinez-Palacios: Draft preparation and hybrid educational 
419 
intervention 
design. 
Pérez-Camargo: 
Nutritonal 
intervention 
design 
and 
420 
implementation. Cedillo-Compeán: Oncological rehabilitation intervention design 
421 
and implementation. Rodríguez-Fonseca: Mindfulness specialist, hybrid educational 
422 
intervention design and implementation. Blandón-Hernández and Labra-Alvarado: 
423 
Psychological and Mindfulness Intervention Implementation. Gálvez-Hernández and 
424 
Bejarano-Colina: Psychological intervention design and implementation. Villarreal-
425 
Garza: Reviewer and protocol design. Cabrera-Nieto, Barranco-Cortés, González-
426 
Pérez, Madariaga-Cobos: Nutritional intervention implementation. Bargalló-Rocha, 
427 
Matus-Santos, Espinosa-Fernández and Cabrera-Galeana oncological follow-up 
428 
protocol and patient reference to the program. Mohar-Betancourt: Reviewer and 
429 
protocol design. 
430 
Conflict of interest 
431 
The authors declare no conflicts of interest.  
432 
Patient consent for publication. Not required 
433 
Ethics approval 
434 
The authors declare that this study was conducted according to the Declaration of 
435 
Helsinki, and all procedures were performed with adequate understanding and 
436 
written consent from the individuals. The study protocol was approved by the Ethics 
437 
Committee of Instituto Nacional de Cancerología (023-005-OMI, CEI-025022). 
438 
Funding 
439 
None. At the time of publication, the project had not received any specific grant from 
440 
public, commercial, or not-for-profit funding agencies or laboratories. 
441 

17 
 
Data availability statement.  
442 
Study results are not available yet. 
443 
 
444 
1.      
Amadou A, Torres-Mejía G, Hainaut P, Romieu I. Breast cancer in 
445 
Latin America: global burden, patterns, and risk factors. 
446 
2.      
Bessonneau V, Rudel RA. Mapping the human exposome to uncover 
447 
the causes of breast cancer. Int J Environ Res Public Health. 2020 Jan 1;17(1). 
448 
3.      
Fang M, Hu L, Chen D, Guo Y, Liu J, Lan C, et al. Exposome in human 
449 
health: Utopia or wonderland? Vol. 2, The Innovation. Cell Press; 2021. 
450 
4.      
Daiber A, Kröller-Schön S, Frenis K, Oelze M, Kalinovic S, Vujacic-
451 
Mirski K, et al. Environmental noise induces the release of stress hormones 
452 
and inflammatory signaling molecules leading to oxidative stress and vascular 
453 
dysfunction—Signatures of the internal exposome. Vol. 45, BioFactors. 
454 
Blackwell Publishing Inc.; 2019. p. 495–506. 
455 
5.      
Kalita-de Croft P, Sharma S, Sobrevia L, Salomon C. Extracellular 
456 
vesicle interactions with the external and internal exposome in mediating 
457 
carcinogenesis. Vol. 87, Molecular Aspects of Medicine. Elsevier Ltd; 2022. 
458 
6.      
Reynoso Noverón N, Villarreal Garza C, Soto Pérez de Celis E, Arce 
459 
Salinas C, Matus Santos J, Ramírez Ugalde MT, et al. Clinical and 
460 
Epidemiological Profile of Breast Cancer in Mexico: Results of the Seguro 
461 
Popular. 2017. 
462 
7.      
Shaikh H, Bradhurst P, Ma LX, Tan SY, Egger SJ, Vardy JL. Body 
463 
weight management in overweight and obese breast cancer survivors. Vol. 
464 
2020, Cochrane Database of Systematic Reviews. John Wiley and Sons Ltd; 
465 
2020. 
466 
8.      
Villarreal-Garza C, Platas A, Miaja M, Mesa-Chavez F, Garcia-Garcia 
467 
M, Fonseca A, et al. Patients’ satisfaction with a supportive care program for 
468 
young breast cancer patients in Mexico: Joven & Fuerte supports patients’ 
469 
needs and eases their illness process. Supportive Care in Cancer. 2020 Oct 
470 
1;28(10):4943–51. 
471 
9.      
Bustamante-Marin XM, Merlino JL, Devericks E, Carson MS, Hursting 
472 
SD, Stewart DA. Mechanistic Targets and Nutritionally Relevant Intervention 
473 

18 
 
Strategies to Break Obesity–Breast Cancer Links. Vol. 12, Frontiers in 
474 
Endocrinology. Frontiers Media S.A.; 2021. 
475 
10.    
Ee C, Cave A, Vaddiparthi V, Naidoo D, Boyages J. Factors associated 
476 
with weight gain after breast cancer: Results from a community-based survey 
477 
of Australian women. Breast. 2023 Jun 1;69:491–8. 
478 
11.    
Nyrop KA, Deal AM, Shachar SS, Park J, Choi SK, Lee JT, et al. 
479 
Weight trajectories in women receiving systemic adjuvant therapy for breast 
480 
cancer. Breast Cancer Res Treat. 2020 Feb 1;179(3):709–20. 
481 
12.    
Perry S, Kowalski TL, Chang CH. Quality of life assessment in women 
482 
with breast cancer: Benefits, acceptability and utilization. Vol. 5, Health and 
483 
Quality of Life Outcomes. 2007. 
484 
13.    
Villarreal-Garza C, Águila C, Platas A, Lara-Guerra H. Cáncer de 
485 
mama en mujeres jóvenes en México: necesidades y retos clínicos. Revista 
486 
de Investigación Clínica. 2014;66(6):547–88. 
487 
14.    
Campbell-Enns H, Woodgate R. The psychosocial experiences of 
488 
women with breast cancer across the lifespan: a systematic review protocol. 
489 
JBI Database System Rev Implement Rep. 2015 Jan 1;13(1):112–21. 
490 
15.    
Montagnese C, Porciello G, Vitale S, Palumbo E, Crispo A, Grimaldi 
491 
M, et al. Quality of life in women diagnosed with breast cancer after a 12-month 
492 
treatment of lifestyle modifications. Nutrients. 2021 Jan 1;13(1):1–15. 
493 
16.    
Ruiz-Vozmediano J, Löhnchen S, Jurado L, Recio R, Rodríguez-
494 
Carrillo A, López M, et al. Influence of a Multidisciplinary Program of Diet, 
495 
Exercise, and Mindfulness on the Quality of Life of Stage IIA-IIB Breast Cancer 
496 
Survivors. Integr Cancer Ther. 2020;19. 
497 
17.    
Richards J, Arensberg MB, Thomas S, Kerr KW, Hegazi R, Bastasch 
498 
M. Impact of early incorporation of nutrition interventions as a component of 
499 
cancer therapy in adults: A review. Vol. 12, Nutrients. MDPI AG; 2020. p. 1–
500 
19. 
501 
18.    
Dieli-Conwright CM, Wong L, Waliany S, Bernstein L, Salehian B, 
502 
Mortimer JE. An observational study to examine changes in metabolic 
503 
syndrome components in patients with breast cancer receiving neoadjuvant or 
504 
adjuvant chemotherapy. Cancer. 2016 Sep 1;122(17):2646–53. 
505 

19 
 
19.    
Snetselaar LG, de Jesus JM, DeSilva DM, Stoody EE. Dietary 
506 
Guidelines for Americans, 2020-2025: Understanding the Scientific Process, 
507 
Guidelines, 
and 
Key 
Recommendations. 
Nutr 
Today. 
2021 
Nov-
508 
Dec;56(6):287-295.   
509 
20.    
Urech C, Grossert A, Alder J, Scherer S, Handschin B, Kasenda B, et 
510 
al. Web-Based Stress Management for Newly Diagnosed Patients With 
511 
Cancer (STREAM): A Randomized, Wait-List Controlled Intervention Study. J 
512 
Clin 
Oncol 
[Internet]. 
2018;36:780–8. 
Available 
from: 
513 
https://doi.org/10.1200/JCO.2017. 
514 
21.    
Fowler S. Diabetes Prevention Program (V8) [Dataset]. NIDDK Central 
515 
Repository. 2023; 
516 
22.    
Hauner D, Rack B, Friedl T, Hepp P, Janni W, Hauner H. Rationale 
517 
and description of a lifestyle intervention programme to achieve moderate 
518 
weight loss in women with non-metastatic breast cancer: The lifestyle 
519 
intervention part of the SUCCESS C Study. BMJ Nutr Prev Health. 2020 Dec 
520 
1;3(2):213–9. 
521 
23.    
Di Meglio A, Martin E, Crane TE, Charles C, Barbier A, Raynard B, et 
522 
al. A phase III randomized trial of weight loss to reduce cancer-related fatigue 
523 
among overweight and obese breast cancer patients: MEDEA Study design. 
524 
Trials. 2022 Dec 1;23(1). 
525 
24.    
Febvey-Combes O, Jobard E, Rossary A, Pialoux V, Foucaut AM, 
526 
Morelle M, et al. Effects of an Exercise and Nutritional Intervention on 
527 
Circulating Biomarkers and Metabolomic Profiling During Adjuvant Treatment 
528 
for Localized Breast Cancer: Results From the PASAPAS Feasibility 
529 
Randomized Controlled Trial. Integr Cancer Ther. 2021;20. 
530 
1. 
Amadou A, Torres-Mejía G, Hainaut P, Romieu I. Breast cancer in 
531 
Latin America: global burden, patterns, and risk factors.  
532 
2. 
Bessonneau V, Rudel RA. Mapping the human exposome to uncover 
533 
the causes of breast cancer. Int J Environ Res Public Health. 2020 Jan 1;17(1).  
534 
3. 
Fang M, Hu L, Chen D, Guo Y, Liu J, Lan C, et al. Exposome in human 
535 
health: Utopia or wonderland? Vol. 2, The Innovation. Cell Press; 2021.  
536 
4. 
Daiber A, Kröller-Schön S, Frenis K, Oelze M, Kalinovic S, Vujacic-
537 
Mirski K, et al. Environmental noise induces the release of stress hormones 
538 
and inflammatory signaling molecules leading to oxidative stress and vascular 
539 

20 
 
dysfunction—Signatures of the internal exposome. Vol. 45, BioFactors. 
540 
Blackwell Publishing Inc.; 2019. p. 495–506.  
541 
5. 
Kalita-de Croft P, Sharma S, Sobrevia L, Salomon C. Extracellular 
542 
vesicle interactions with the external and internal exposome in mediating 
543 
carcinogenesis. Vol. 87, Molecular Aspects of Medicine. Elsevier Ltd; 2022.  
544 
6. 
Reynoso Noverón N, Villarreal Garza C, Soto Pérez de Celis E, Arce 
545 
Salinas C, Matus Santos J, Ramírez Ugalde MT, et al. Clinical and 
546 
Epidemiological Profile of Breast Cancer in Mexico: Results of the Seguro 
547 
Popular. 2017.  
548 
7. 
Shaikh H, Bradhurst P, Ma LX, Tan SY, Egger SJ, Vardy JL. Body 
549 
weight management in overweight and obese breast cancer survivors. Vol. 
550 
2020, Cochrane Database of Systematic Reviews. John Wiley and Sons Ltd; 
551 
2020.  
552 
8. 
Villarreal-Garza C, Platas A, Miaja M, Mesa-Chavez F, Garcia-Garcia 
553 
M, Fonseca A, et al. Patients’ satisfaction with a supportive care program for 
554 
young breast cancer patients in Mexico: Joven & Fuerte supports patients’ 
555 
needs and eases their illness process. Supportive Care in Cancer. 2020 Oct 
556 
1;28(10):4943–51.  
557 
9. 
Bustamante-Marin XM, Merlino JL, Devericks E, Carson MS, Hursting 
558 
SD, Stewart DA. Mechanistic Targets and Nutritionally Relevant Intervention 
559 
Strategies to Break Obesity–Breast Cancer Links. Vol. 12, Frontiers in 
560 
Endocrinology. Frontiers Media S.A.; 2021.  
561 
10. 
Ee C, Cave A, Vaddiparthi V, Naidoo D, Boyages J. Factors associated 
562 
with weight gain after breast cancer: Results from a community-based survey 
563 
of Australian women. Breast. 2023 Jun 1;69:491–8.  
564 
11. 
Nyrop KA, Deal AM, Shachar SS, Park J, Choi SK, Lee JT, et al. 
565 
Weight trajectories in women receiving systemic adjuvant therapy for breast 
566 
cancer. Breast Cancer Res Treat. 2020 Feb 1;179(3):709–20.  
567 
12. 
Perry S, Kowalski TL, Chang CH. Quality of life assessment in women 
568 
with breast cancer: Benefits, acceptability and utilization. Vol. 5, Health and 
569 
Quality of Life Outcomes. 2007.  
570 
13. 
Villarreal-Garza C, Águila C, Platas A, Lara-Guerra H. Cáncer de 
571 
mama en mujeres jóvenes en México: necesidades y retos clínicos. Revista 
572 
de Investigación Clínica. 2014;66(6):547–88.  
573 

21 
 
14. 
Campbell-Enns H, Woodgate R. The psychosocial experiences of 
574 
women with breast cancer across the lifespan: a systematic review protocol. 
575 
JBI Database System Rev Implement Rep. 2015 Jan 1;13(1):112–21.  
576 
15. 
Montagnese C, Porciello G, Vitale S, Palumbo E, Crispo A, Grimaldi 
577 
M, et al. Quality of life in women diagnosed with breast cancer after a 12-month 
578 
treatment of lifestyle modifications. Nutrients. 2021 Jan 1;13(1):1–15.  
579 
16. 
Ruiz-Vozmediano J, Löhnchen S, Jurado L, Recio R, Rodríguez-
580 
Carrillo A, López M, et al. Influence of a Multidisciplinary Program of Diet, 
581 
Exercise, and Mindfulness on the Quality of Life of Stage IIA-IIB Breast Cancer 
582 
Survivors. Integr Cancer Ther. 2020;19.  
583 
17. 
Richards J, Arensberg MB, Thomas S, Kerr KW, Hegazi R, Bastasch 
584 
M. Impact of early incorporation of nutrition interventions as a component of 
585 
cancer therapy in adults: A review. Vol. 12, Nutrients. MDPI AG; 2020. p. 1–
586 
19.  
587 
18. 
Dieli-Conwright CM, Wong L, Waliany S, Bernstein L, Salehian B, 
588 
Mortimer JE. An observational study to examine changes in metabolic 
589 
syndrome components in patients with breast cancer receiving neoadjuvant or 
590 
adjuvant chemotherapy. Cancer. 2016 Sep 1;122(17):2646–53.  
591 
19. 
U.S. Department of Agriculture. https://www.myplate.gov/. My Plate.  
592 
20. 
Urech C, Grossert A, Alder J, Scherer S, Handschin B, Kasenda B, et 
593 
al. Web-Based Stress Management for Newly Diagnosed Patients With 
594 
Cancer (STREAM): A Randomized, Wait-List Controlled Intervention Study. J 
595 
Clin 
Oncol 
[Internet]. 
2018;36:780–8. 
Available 
from: 
596 
https://doi.org/10.1200/JCO.2017. 
597 
21. 
Fowler S. Diabetes Prevention Program (V8) [Dataset]. NIDDK Central 
598 
Repository. 2023;  
599 
22. 
Hauner D, Rack B, Friedl T, Hepp P, Janni W, Hauner H. Rationale 
600 
and description of a lifestyle intervention programme to achieve moderate 
601 
weight loss in women with non-metastatic breast cancer: The lifestyle 
602 
intervention part of the SUCCESS C Study. BMJ Nutr Prev Health. 2020 Dec 
603 
1;3(2):213–9.  
604 
23. 
Di Meglio A, Martin E, Crane TE, Charles C, Barbier A, Raynard B, et 
605 
al. A phase III randomized trial of weight loss to reduce cancer-related fatigue 
606 

22 
 
among overweight and obese breast cancer patients: MEDEA Study design. 
607 
Trials. 2022 Dec 1;23(1).  
608 
24. 
Febvey-Combes O, Jobard E, Rossary A, Pialoux V, Foucaut AM, 
609 
Morelle M, et al. Effects of an Exercise and Nutritional Intervention on 
610 
Circulating Biomarkers and Metabolomic Profiling During Adjuvant Treatment 
611 
for Localized Breast Cancer: Results From the PASAPAS Feasibility 
612 
Randomized Controlled Trial. Integr Cancer Ther. 2021;20.  
613 
25. 
Batsis JA, McClure AC, Weintraub AB, Sette D, Rotenberg S, Stevens 
614 
CJ, et al. Barriers and facilitators in implementing a pilot, pragmatic, 
615 
telemedicine-delivered healthy lifestyle program for obesity management in a 
616 
rural, academic obesity clinic. Implement Sci Commun. 2020 Dec 1;1(1).  
617 
26. 
King DK, Shoup JA, Raebel MA, Anderson CB, Wagner NM, Ritzwoller 
618 
DP, et al. Planning for Implementation Success Using RE-AIM and CFIR 
619 
Frameworks: A Qualitative Study. Front Public Health. 2020 Mar 3;8.  
620 
27. 
De Cicco P, Catani MV, Gasperi V, Sibilano M, Quaglietta M, Savini I. 
621 
Nutrition and breast cancer: A literature review on prevention, treatment and 
622 
recurrence. Vol. 11, Nutrients. MDPI AG; 2019.  
623 
28. 
Hoy MK, Winters BL, Chlebowski RT, Papoutsakis C, Shapiro A, Lubin 
624 
MP, et al. Implementing a Low-Fat Eating Plan in the Women’s Intervention 
625 
Nutrition Study. J Am Diet Assoc. 2009 Apr;109(4):688–96.  
626 
29. 
Demark-Wahnefried W. Reduced rates of metabolism and decreased 
627 
physical activity in breast cancer patients receiving adjuvant chemotherapy1 3 
628 
[Internet]. 
Vol. 
65. 
1997. 
Available 
from: 
629 
https://academic.oup.com/ajcn/article-abstract/65/5/1495/4655500 
630 
30. 
Makari-Judson G, Braun B, Joseph Jerry D, Mertens WC. Weight gain 
631 
following breast cancer diagnosis: Implication and proposed mechanisms. Vol. 
632 
5, World Journal of Clinical Oncology. Baishideng Publishing Group Co., 
633 
Limited; 2014. p. 272–82.  
634 
31. 
Kabat-Zinn J. Mindfulness-based interventions in context: Past, 
635 
present, and future. Vol. 10, Clinical Psychology: Science and Practice. 2003. 
636 
p. 144–56.  
637 
32. 
Guarino A, Polini C, Forte G, Favieri F, Boncompagni I, Casagrande 
638 
M. The effectiveness of psychological treatments in women with breast cancer: 
639 

23 
 
A systematic review and meta-analysis. Vol. 9, Journal of Clinical Medicine. 
640 
MDPI; 2020.  
641 
33. 
Lengacher CA, Reich RR, Paterson CL, Shelton M, Shivers S, 
642 
Ramesar S, et al. A Large Randomized Trial: Effects of Mindfulness-Based 
643 
Stress Reduction (MBSR) for Breast Cancer (BC) Survivors on Salivary 
644 
Cortisol and IL-6. Biol Res Nurs. 2019 Jan 1;21(1):39–49.  
645 
34. 
Widiasih R, Ermiati, Jayanti TN, Rais Y. Psychosocial Interventions for 
646 
Improving the Quality of Life in Breast Cancer Survivors: A Literature Review. 
647 
In: IOP Conference Series: Earth and Environmental Science. Institute of 
648 
Physics Publishing; 2019.  
649 
35. 
Rogers LQ, Courneya KS, Oster RA, Anton PM, Robbs RS, Forero A, 
650 
et al. Physical activity and sleep quality in breast cancer survivors: A 
651 
randomized trial. Med Sci Sports Exerc. 2017 Oct 1;49(10):2009–15.  
652 
36. 
Van Den Berg SW, Gielissen MFM, Custers JAE, Van Der Graaf WTA, 
653 
Ottevanger PB, Prins JB. BREATH: Web-based self-management for 
654 
psychological adjustment after primary breast cancer-results of a multicenter 
655 
randomized controlled trial. Journal of Clinical Oncology. 2015 Sep 
656 
1;33(25):2763–71. 
657