Breast NeoplasmNCT06090747
Improving Lifestyle Behavior by "Joven, Fuerte y Saludable" Multidisciplinary Program.
A study testing Hybrid lifestyle educational multidisciplinary intervention. and Hybrid lifestyle personalized multidisciplinary intervention. in people with Breast Neoplasm, run by Instituto Nacional de Cancerologia de Mexico at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Breast Neoplasm
- What is being tested?
- Hybrid lifestyle educational multidisciplinary intervention. and Hybrid lifestyle personalized multidisciplinary intervention.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteMexico
- Study dates
- 9 Mar 2023to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Dr. Marlid Cruz Ramos
México, 14370
Marlid Cruz Ramos, PhD, +525516900151, marlid.cruz@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Neoplasm
- Being tested
- Hybrid lifestyle educational multidisciplinary intervention., Hybrid lifestyle personalized multidisciplinary intervention.
- Keywords
- Multidisciplinary, Intervention, Lifestyle, Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid lifestyle educational multidisciplinary intervention.Behavioural
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.
Hybrid lifestyle personalized multidisciplinary intervention.Behavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Evaluate the effect of hybrid educational intervention in Lifestyle behavior. | Active comparator | Group 1: hybrid educational intervention Receives: Behavioral: Hybrid lifestyle educational multidisciplinary intervention. |
| Evaluate the effect of hybrid personalized intervention in Lifestyle behavior | Experimental | Group 2: hybrid personalized lifestyle intervention delivered by a multidisciplinary team of specialists in oncology, nutrition, psychology, rehabilitation and mindfulness. Receives: Behavioral: Hybrid lifestyle personalized multidisciplinary intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adoption of healthy lifestyle
The patient lifestyle compliance measured by the scores of World Cancer Research Fund (WCRF) / American Institute for Cancer Research (AICR) questionnaire, SCORE ≥ 5
Measured: Baseline evaluation and final evaluation (18 months).
Changes on 24-hour reminder
Evaluate the changes on daily nutritional intake (total energy, carbohydrate, protein and, lipids grams)
Measured: Baseline, 3, 6, 12 and 18 months.
Education and Motivational effectiveness of digital tools.
To evaluate the motivational and educational effect of a personalized follow-up by phone, Zoom, WhatsApp, or social networks (number of views in videos, number of Zoom sessions, number o WA calls).
Measured: 3, 6, 12 and 18 months.
Physical Activity changes
Evaluate the changes on physical activitiy by International Physical Activity Questionnaire (IPAQ) score (high: 1500 to 3000 METS per/week; moderate: 600 MET per/week.
Measured: Baseline, 3, 6,12 and 18 months.
Quality of sleep changes
Evaluate the quality of sleep changes by Pittsburgh Sleep Quality Index (PSQI). Total Score 0 to 21. Score 0 (No sleep difficulty); Score 1 to7 (mild sleep difficulty); Score 8-14 (moderate sleep dificulty); 15-21 (severe sleep difficulty).
Measured: Baseline, 3, 6,12 and 18 months.
Depression risk evaluation
Patient Health Questionnaire (PHQ-9) 1-4 Minimal depression 5-9 Mild depression 10-14 Moderate depression 15-19 Moderately severe depression 20-27 Severe depression
Measured: Baseline, 3, 6,12 and 18 months.
Anxiety risk evaluation
Generalized Anxiety Disorder Assessment (GAD-7) 0-4: minimal anxiety 5-9: mild anxiety 10-14: moderate anxiety 15-21: severe anxiety
Measured: Baseline, 3, 6,12 and 18 months.
Minfulness evaluation - How having a concentrated mind affects on daily life
Five Facet Mindfulness Questionnaire (FFMQ) 1-2: Lack of concentrated mind 3: Intermediate attention awareness 4-5: Advance attention awareness
Measured: Baseline, 3, 6,12 and 18 months.
Body composition - Body fat
To evaluate the Effect of lifestyle intervention on:
Body fat percentage (acceptable fat percentage <31%)
Measured: Baseline, 3, 6,12 and 18 months.
Biochemical parameters - Inflammatory cytokines
To evaluate the effect of lifestyle intervention on biochemical parameters:
Cytokines level
Measured: Baseline, 3, 6,12 and 18 months.
Anthropometric measurements - Body weight
Changes in:
Body weight (kg)
Measured: Baseline, 3, 6,12 and 18 months.
Minfulness evaluation - Disposition to attention awareness
Mindful Attention Awareness Scale (MAAS) 1-2: Lack of attention awareness 3: Intermediate attention awareness 4-5: Advance attention awareness 6: Overvalued (questionnaire was notanswered honestly)
Measured: Baseline, 3, 6,12 and 18 months.
Minfulness evaluation - Disposition to mindfulness
Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) 1-2: Lack of disposition 3: Intermediate disposition 4: Advance into mindfulness
Measured: Baseline, 3, 6,12 and 18 months.
Body composition - Muscle
To evaluate the Effect of lifestyle intervention on:
Muscle (muscle mass in kg and muscle mass index ≤6.42 kg/m2)
Measured: Baseline, 3, 6,12 and 18 months.
Biochemical parameters - Glucose
To evaluate the effect of lifestyle intervention on biochemical parameters:
Blood glucose <135mg/dL
Measured: Baseline, 3, 6,12 and 18 months.
Biochemical parameters - Lipid profile
To evaluate the effect of lifestyle intervention on biochemical parameters:
LDL<100mg/dL, HDL >40mg/dL and triglycerides <150mg/dL)
Measured: Baseline, 3, 6,12 and 18 months.
Anthropometric measurements - Waist circumference
Changes in:
Waist circumference (cm)
Measured: Baseline, 3, 6,12 and 18 months.
Anthropometric measurements - Waist to hip ratio
Changes in:
Waist to hip ratio (<0.8)
Measured: Baseline, 3, 6,12 and 18 months.
Secondary outcomes (4)
Improvement of quality of life parameters with lifestyle intervention- QLQ-C30
Effect of lifestyle intervention on quality of life measured by European Organization of Research and Treatment of Cancer Quality of Life Questionnarie (QLQ-C30)
Measured: Baseline, 3, 6 ,12 and 18 months.
Barriers and challenges to implement the lifestyle intervention - CFIR
To identify the barriers and challenges for the implementation of the healthy lifestyle intervention.
CFIR (Consolidated Framework for Implementation Research) - qualitative evaluation
Measured: 3, 6, 12 and 18 months.
Barriers and challenges to implement the lifestyle intervention - RE-AIM
To identify the barriers and challenges for the implementation of the healthy lifestyle intervention.
RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance)
Measured: 3, 6, 12 and 18 months.
Improvement of quality of life parameters with lifestyle intervention- QLQ-BR23
Effect of lifestyle intervention on quality of life measured by Quality of Life Questionnarie Breast Cancer (QLQ-BR23) - Sympton scale score.
Measured: Baseline, 3, 6 ,12 and 18 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start9 Mar 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (40)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- None (open label)
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cancerologia de Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- Anahuac University, Tecnologico de Monterrey, Instituto Nacional de Rehabilitacion, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Responsible party
- Principal investigator, Marlid Cruz Ramos, Instituto Nacional de Cancerologia de Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06090747
- Sponsor's protocol ID
- 023-005-OMI(CEI-05022)
- Status last verified
- Oct 2023
- First submitted
- 7 Sep 2023
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Amadou A, Torres-Mejia G, Hainaut P, Romieu I. Breast cancer in Latin America: global burden, patterns, and risk factors. Salud Publica Mex. 2014 Sep-Oct;56(5):547-54. doi: 10.21149/spm.v56i5.7379.
PubMed 25604300Bessonneau V, Rudel RA. Mapping the Human Exposome to Uncover the Causes of Breast Cancer. Int J Environ Res Public Health. 2019 Dec 27;17(1):189. doi: 10.3390/ijerph17010189.
PubMed 31892107Fang M, Hu L, Chen D, Guo Y, Liu J, Lan C, Gong J, Wang B. Exposome in human health: Utopia or wonderland? Innovation (Camb). 2021 Oct 6;2(4):100172. doi: 10.1016/j.xinn.2021.100172. eCollection 2021 Nov 28.
PubMed 34746906Daiber A, Kroller-Schon S, Frenis K, Oelze M, Kalinovic S, Vujacic-Mirski K, Kuntic M, Bayo Jimenez MT, Helmstadter J, Steven S, Korac B, Munzel T. Environmental noise induces the release of stress hormones and inflammatory signaling molecules leading to oxidative stress and vascular dysfunction-Signatures of the internal exposome. Biofactors. 2019 Jul;45(4):495-506. doi: 10.1002/biof.1506. Epub 2019 Apr 2.
PubMed 30937979Kalita-de Croft P, Sharma S, Sobrevia L, Salomon C. Extracellular vesicle interactions with the external and internal exposome in mediating carcinogenesis. Mol Aspects Med. 2022 Oct;87:101039. doi: 10.1016/j.mam.2021.101039. Epub 2021 Oct 8.
PubMed 34629184Barquera S, Hernandez-Barrera L, Trejo-Valdivia B, Shamah T, Campos-Nonato I, Rivera-Dommarco J. [Obesity in Mexico, prevalence andtrends in adults. Ensanut 2018-19.]. Salud Publica Mex. 2020 Nov-Dec;62(6):682-692. doi: 10.21149/11630. Spanish.
PubMed 33620965Reynoso-Noveron N, Villarreal-Garza C, Soto-Perez-de-Celis E, Arce-Salinas C, Matus-Santos J, Ramirez-Ugalde MT, Alvarado-Miranda A, Cabrera-Galeana P, Meneses-Garcia A, Lara-Medina F, Bargallo-Rocha E, Mohar A. Clinical and Epidemiological Profile of Breast Cancer in Mexico: Results of the Seguro Popular. J Glob Oncol. 2017 Dec;3(6):757-764. doi: 10.1200/JGO.2016.007377. Epub 2017 Feb 8.
PubMed 29244990Villarreal-Garza C, Platas A, Miaja M, Fonseca A, Mesa-Chavez F, Garcia-Garcia M, Chapman JA, Lopez-Martinez EA, Pineda C, Mohar A, Galvez-Hernandez CL, Castro-Sanchez A, Martinez-Cannon BA, Barragan-Carrillo R, Munoz-Lozano JF, Goss P, Bargallo-Rocha JE, Aguilar D, Cardona S, Canavati M. Young Women With Breast Cancer in Mexico: Results of the Pilot Phase of the Joven & Fuerte Prospective Cohort. JCO Glob Oncol. 2020 Mar;6:395-406. doi: 10.1200/JGO.19.00264.
PubMed 32142405Shaikh H, Bradhurst P, Ma LX, Tan SYC, Egger SJ, Vardy JL. Body weight management in overweight and obese breast cancer survivors. Cochrane Database Syst Rev. 2020 Dec 11;12(12):CD012110. doi: 10.1002/14651858.CD012110.pub2.
PubMed 33305350Bustamante-Marin XM, Merlino JL, Devericks E, Carson MS, Hursting SD, Stewart DA. Mechanistic Targets and Nutritionally Relevant Intervention Strategies to Break Obesity-Breast Cancer Links. Front Endocrinol (Lausanne). 2021 Mar 17;12:632284. doi: 10.3389/fendo.2021.632284. eCollection 2021.
PubMed 33815289Villarreal-Garza C, Platas A, Miaja M, Mesa-Chavez F, Garcia-Garcia M, Fonseca A, Pineda C, de la Rosa-Pacheco S, Galvez-Hernandez CL, Bargallo-Rocha E, Castro J, Rodriguez-Gomez D, Cruz-Ramos M, Mohar A. Patients' satisfaction with a supportive care program for young breast cancer patients in Mexico: Joven & Fuerte supports patients' needs and eases their illness process. Support Care Cancer. 2020 Oct;28(10):4943-4951. doi: 10.1007/s00520-020-05334-y. Epub 2020 Feb 4.
PubMed 32020358Perry S, Kowalski TL, Chang CH. Quality of life assessment in women with breast cancer: benefits, acceptability and utilization. Health Qual Life Outcomes. 2007 May 2;5:24. doi: 10.1186/1477-7525-5-24.
PubMed 17474993Montagnese C, Porciello G, Vitale S, Palumbo E, Crispo A, Grimaldi M, Calabrese I, Pica R, Prete M, Falzone L, Libra M, Cubisino S, Poletto L, Martinuzzo V, Coluccia S, Esindi N, Nocerino F, Minopoli A, Grilli B, Fiorillo PC, Cuomo M, Cavalcanti E, Thomas G, Cianniello D, Pinto M, De Laurentiis M, Pacilio C, Rinaldo M, D'Aiuto M, Serraino D, Massarut S, Caggiari L, Evangelista C, Steffan A, Catalano F, Banna GL, Scandurra G, Ferrau F, Rossello R, Antonelli G, Guerra G, Farina A, Messina F, Riccardi G, Gatti D, Jenkins DJA, Celentano E, Botti G, Augustin LSA. Quality of Life in Women Diagnosed with Breast Cancer after a 12-Month Treatment of Lifestyle Modifications. Nutrients. 2020 Dec 31;13(1):136. doi: 10.3390/nu13010136.
PubMed 33396551Ruiz-Vozmediano J, Lohnchen S, Jurado L, Recio R, Rodriguez-Carrillo A, Lopez M, Mustieles V, Exposito M, Arroyo-Morales M, Fernandez MF. Influence of a Multidisciplinary Program of Diet, Exercise, and Mindfulness on the Quality of Life of Stage IIA-IIB Breast Cancer Survivors. Integr Cancer Ther. 2020 Jan-Dec;19:1534735420924757. doi: 10.1177/1534735420924757.
PubMed 32462950Ee C, Cave A, Vaddiparthi V, Naidoo D, Boyages J. Factors associated with weight gain after breast cancer: Results from a community-based survey of Australian women. Breast. 2023 Jun;69:491-498. doi: 10.1016/j.breast.2023.01.012. Epub 2023 Jan 25.
PubMed 36710237
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efecto de Una intervención Multidisciplinaria de Estilo de Vida Sobre el Exposoma de Pacientes premenopáusicas Con cáncer de Mama Estadios I-III.
- ClinicalTrials.gov ID
- NCT06090747
- Acronym / sponsor ID
- 023-005-OMI(CEI-05022)
- Conditions
- Breast Neoplasm
- Keywords
- Multidisciplinary, Intervention, Lifestyle, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Instituto Nacional de Cancerologia de MexicoUniversity, hospital or other
- Collaborators
- Anahuac University, Tecnologico de Monterrey, Instituto Nacional de Rehabilitacion, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Study start
- 9 Mar 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 19 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Evaluate the effect of hybrid educational intervention in Lifestyle behavior. | Active comparator | Behavioral: Hybrid lifestyle educational multidisciplinary intervention.Group 1: hybrid educational intervention |
| Evaluate the effect of hybrid personalized intervention in Lifestyle behavior | Experimental | Behavioral: Hybrid lifestyle personalized multidisciplinary intervention.Group 2: hybrid personalized lifestyle intervention delivered by a multidisciplinary team of specialists in oncology, nutrition, psychology, rehabilitation and mindfulness. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Evaluate the effect of hybrid educational intervention in Lifestyle behavior. |
| 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 | Behavioural | Evaluate the effect of hybrid personalized intervention in Lifestyle behavior |
Primary outcome
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
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)
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).
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.
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).
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
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
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
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%)
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
Anthropometric measurements - Body weight
Time frame: Baseline, 3, 6,12 and 18 months.
Changes in: Body weight (kg)
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)
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
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)
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
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)
Anthropometric measurements - Waist circumference
Time frame: Baseline, 3, 6,12 and 18 months.
Changes in: Waist circumference (cm)
Anthropometric measurements - Waist to hip ratio
Time frame: Baseline, 3, 6,12 and 18 months.
Changes in: Waist to hip ratio (<0.8)
4 secondary outcomes
Improvement of quality of life parameters with lifestyle intervention- QLQ-C30
Time frame: Baseline, 3, 6 ,12 and 18 months.
Barriers and challenges to implement the lifestyle intervention - CFIR
Time frame: 3, 6, 12 and 18 months.
Barriers and challenges to implement the lifestyle intervention - RE-AIM
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Background: PubMed 25604300Amadou A, Torres-Mejia G, Hainaut P, Romieu I. Breast cancer in Latin America: global burden, patterns, and risk factors. Salud Publica Mex. 2014 Sep-Oct;56(5):547-54. doi: 10.21149/spm.v56i5.7379.
- Background: PubMed 31892107Bessonneau V, Rudel RA. Mapping the Human Exposome to Uncover the Causes of Breast Cancer. Int J Environ Res Public Health. 2019 Dec 27;17(1):189. doi: 10.3390/ijerph17010189.
- Background: PubMed 34746906Fang M, Hu L, Chen D, Guo Y, Liu J, Lan C, Gong J, Wang B. Exposome in human health: Utopia or wonderland? Innovation (Camb). 2021 Oct 6;2(4):100172. doi: 10.1016/j.xinn.2021.100172. eCollection 2021 Nov 28.
- Background: PubMed 30937979Daiber A, Kroller-Schon S, Frenis K, Oelze M, Kalinovic S, Vujacic-Mirski K, Kuntic M, Bayo Jimenez MT, Helmstadter J, Steven S, Korac B, Munzel T. Environmental noise induces the release of stress hormones and inflammatory signaling molecules leading to oxidative stress and vascular dysfunction-Signatures of the internal exposome. Biofactors. 2019 Jul;45(4):495-506. doi: 10.1002/biof.1506. Epub 2019 Apr 2.
- Background: PubMed 34629184Kalita-de Croft P, Sharma S, Sobrevia L, Salomon C. Extracellular vesicle interactions with the external and internal exposome in mediating carcinogenesis. Mol Aspects Med. 2022 Oct;87:101039. doi: 10.1016/j.mam.2021.101039. Epub 2021 Oct 8.
- Background: PubMed 33620965Barquera S, Hernandez-Barrera L, Trejo-Valdivia B, Shamah T, Campos-Nonato I, Rivera-Dommarco J. [Obesity in Mexico, prevalence andtrends in adults. Ensanut 2018-19.]. Salud Publica Mex. 2020 Nov-Dec;62(6):682-692. doi: 10.21149/11630. Spanish.
- Background: PubMed 29244990Reynoso-Noveron N, Villarreal-Garza C, Soto-Perez-de-Celis E, Arce-Salinas C, Matus-Santos J, Ramirez-Ugalde MT, Alvarado-Miranda A, Cabrera-Galeana P, Meneses-Garcia A, Lara-Medina F, Bargallo-Rocha E, Mohar A. Clinical and Epidemiological Profile of Breast Cancer in Mexico: Results of the Seguro Popular. J Glob Oncol. 2017 Dec;3(6):757-764. doi: 10.1200/JGO.2016.007377. Epub 2017 Feb 8.
- Background: PubMed 32142405Villarreal-Garza C, Platas A, Miaja M, Fonseca A, Mesa-Chavez F, Garcia-Garcia M, Chapman JA, Lopez-Martinez EA, Pineda C, Mohar A, Galvez-Hernandez CL, Castro-Sanchez A, Martinez-Cannon BA, Barragan-Carrillo R, Munoz-Lozano JF, Goss P, Bargallo-Rocha JE, Aguilar D, Cardona S, Canavati M. Young Women With Breast Cancer in Mexico: Results of the Pilot Phase of the Joven & Fuerte Prospective Cohort. JCO Glob Oncol. 2020 Mar;6:395-406. doi: 10.1200/JGO.19.00264.
- Background: PubMed 33305350Shaikh H, Bradhurst P, Ma LX, Tan SYC, Egger SJ, Vardy JL. Body weight management in overweight and obese breast cancer survivors. Cochrane Database Syst Rev. 2020 Dec 11;12(12):CD012110. doi: 10.1002/14651858.CD012110.pub2.
- Background: PubMed 33815289Bustamante-Marin XM, Merlino JL, Devericks E, Carson MS, Hursting SD, Stewart DA. Mechanistic Targets and Nutritionally Relevant Intervention Strategies to Break Obesity-Breast Cancer Links. Front Endocrinol (Lausanne). 2021 Mar 17;12:632284. doi: 10.3389/fendo.2021.632284. eCollection 2021.
- Background: PubMed 32020358Villarreal-Garza C, Platas A, Miaja M, Mesa-Chavez F, Garcia-Garcia M, Fonseca A, Pineda C, de la Rosa-Pacheco S, Galvez-Hernandez CL, Bargallo-Rocha E, Castro J, Rodriguez-Gomez D, Cruz-Ramos M, Mohar A. Patients' satisfaction with a supportive care program for young breast cancer patients in Mexico: Joven & Fuerte supports patients' needs and eases their illness process. Support Care Cancer. 2020 Oct;28(10):4943-4951. doi: 10.1007/s00520-020-05334-y. Epub 2020 Feb 4.
- Background: PubMed 17474993Perry S, Kowalski TL, Chang CH. Quality of life assessment in women with breast cancer: benefits, acceptability and utilization. Health Qual Life Outcomes. 2007 May 2;5:24. doi: 10.1186/1477-7525-5-24.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid lifestyle educational multidisciplinary intervention. and Hybrid lifestyle personalized multidisciplinary intervention. in people with Breast Neoplasm, run by Instituto Nacional de Cancerologia de Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marlid Cruz Ramos, PhD (+525556280400 ext. 41051, marlid.cruz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adoption of healthy lifestyle (time frame: Baseline evaluation and final evaluation (18 months).). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06090747, which also lists 40 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2023.