Clinical trial · Interventional
Improving Lifestyle Behavior by "Joven, Fuerte y Saludable" Multidisciplinary Program.
Efecto de Una intervención Multidisciplinaria de Estilo de Vida Sobre el Exposoma de Pacientes premenopáusicas Con cáncer de Mama Estadios I-III.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Breast cancer is the leading cause of mortality in women worldwide. Latin-American women are diagnosed at younger ages, in advanced stages, and with aggressive molecular subtypes. Lifestyle seems related to these aggressive conditions and worse outcomes. The present study seeks to evaluate the effect of a hybrid multidisciplinary intervention for implementing a healthy lifestyle to modify the personal and internal exposome of young women with breast cancer. This randomized controlled experimental study with two groups: Group 1: Hybrid multidisciplinary lifestyle education intervention. Group 2: Individualized hybrid multidisciplinary lifestyle interventions. The multidisciplinary lifestyle intervention program includes oncology, nutrition, physiotherapy, and psychology interventions.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasm | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hybrid lifestyle educational multidisciplinary intervention. | Behavioral | — | UNRESOLVED |
| Hybrid lifestyle personalized multidisciplinary intervention. | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Evaluate the effect of hybrid educational intervention in Lifestyle behavior.
- description
- Group 1: hybrid educational intervention
- interventionNames
- Behavioral: Hybrid lifestyle educational multidisciplinary intervention.
- type
- EXPERIMENTAL
- label
- Evaluate the effect of hybrid personalized intervention in Lifestyle behavior
- description
- Group 2: hybrid personalized lifestyle intervention delivered by a multidisciplinary team of specialists in oncology, nutrition, psychology, rehabilitation and mindfulness.
- interventionNames
- Behavioral: Hybrid lifestyle personalized multidisciplinary intervention.
Primary outcomes (18)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Women diagnosed with stage I-III BC, confirmed by pathology and image at the INCAN * Candidates for multidisciplinary treatment including surgery, chemotherapy, and/or hormonal treatments. * Signed the informed consent form * Have access to a mobile phone or any electronic device with an active internet connection to receive the program information. Exclusion Criteria: * Patients with inflammatory cancer * Those with cardiomyopathy or ventricular dysfunction (NYHA \>II), arrythmia secondary to left ventricular ejection alterations that requires medication, previous myocardial infarction, or angina pectoris in the last six months * Receiving treatment for cardiovascular or cerebrovascular disease, inflammatory bowel disease, malabsorption syndrome, rheumatoid arthritis, lupus, thyroid diseases, or Cushing syndrome * Unable to walk for at least 1 km * Have cardiovascular, respiratory, or musculoskeletal diseases that impede physical activity * Pregnant or breastfeeding * Have psychiatric conditions impeding active participation in this protocol * Do not understand Spanish
References
Publications (40)
- BACKGROUNDAmadou 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. PMID 25604300
- BACKGROUNDBessonneau 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. PMID 31892107
- BACKGROUNDFang 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. PMID 34746906
- BACKGROUNDDaiber 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. PMID 30937979
- BACKGROUNDKalita-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. PMID 34629184
- BACKGROUNDBarquera 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. PMID 33620965
- BACKGROUNDReynoso-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.