Actively Recruiting

Phase Not Applicable
Age: 18Years - 40Years
FEMALE
ID06090747

Effect of a Multidisciplinary Lifestyle Intervention on the Exposome of Premenopausal Women with Stage I-III Breast Cancer

Led by Instituto Nacional de Cancerologia de Mexico · Updated on 2023-10-19

146

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

Sponsors

I

Instituto Nacional de Cancerologia de Mexico

Lead Sponsor

A

Anahuac University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Breast cancer is a leading cause of death among women worldwide, especially in Latin America, where younger women are often diagnosed at advanced stages with aggressive tumor types. Lifestyle factors, including diet, physical activity, and psychological stress, influence the internal and external exposome, which impacts breast cancer development and treatment outcomes. This study evaluates how a multidisciplinary lifestyle intervention might affect the personal exposome and health of young women with breast cancer. The trial compares two groups: one receives a hybrid multidisciplinary lifestyle education program delivered through digital tools and face-to-face sessions, while the other receives a personalized hybrid multidisciplinary intervention tailored to clinical evaluations and includes nutritional, psychological, rehabilitation, and mindfulness support. Both groups use digital platforms like apps, workshops, and videos for education and motivational support, with follow-up through various communication methods. Participants will be involved for 18 months, undergoing assessments at baseline and at multiple intervals to measure lifestyle adoption, physical activity, sleep quality, anxiety, depression, mindfulness, body composition, and biochemical markers. Researchers will track adherence through attendance and questionnaires, evaluating quality of life and barriers to lifestyle changes. This comprehensive approach aims to understand how early intervention may improve metabolic control, clinical outcomes, and overall well-being in young breast cancer patients.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 40Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women diagnosed with stage I-III breast cancer confirmed by pathology and imaging at INCAN
  • Candidates for multidisciplinary treatment including surgery, chemotherapy, and/or hormonal therapies
  • Signed informed consent form
  • Have access to a mobile phone or electronic device with active internet connection to receive program information
Not Eligible

You will not qualify if you...

  • Patients with inflammatory breast cancer
  • Cardiomyopathy or ventricular dysfunction (NYHA > II), arrhythmia requiring medication, recent myocardial infarction or angina in past 6 months
  • Receiving treatment for cardiovascular or cerebrovascular disease, inflammatory bowel disease, malabsorption syndrome, rheumatoid arthritis, lupus, thyroid diseases, or Cushing syndrome
  • Unable to walk at least 1 km
  • Cardiovascular, respiratory, or musculoskeletal diseases impeding physical activity
  • Pregnant or breastfeeding
  • Psychiatric conditions preventing active participation
  • Do not understand Spanish

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Participants will be identified and invited by the program navigator at INCAN, then consented.

Treatment

Duration - Up to 18 months

Participants receive a hybrid lifestyle intervention consisting of standardized educational sessions and personalized multidisciplinary support including nutrition, psychology, rehabilitation, and mindfulness through face-to-face and remote digital tools.

Regular assessments at baseline, 3, 6, 12, and 18 months; interventions delivered via face-to-face sessions, phone, Zoom, WhatsApp, and digital platforms.

Trial Site Locations

Total: 1 location

1

Dr. Marlid Cruz Ramos

México, Mexico, 14370

Actively Recruiting

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Research Team

M

Marlid Cruz Ramos, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Environmental noise induces the release of stress hormones and inflammatory signaling molecules leading to oxidative stress and vascular dysfunction-Signatures of the internal exposome.

Andreas Daiber, Swenja Kröller-Schön, Katie Frenis...

https://pubmed.ncbi.nlm.nih.gov/30937979

Extracellular vesicle interactions with the external and internal exposome in mediating carcinogenesis.

Priyakshi Kalita-de Croft, Shayna Sharma, Luis Sobrevia...

https://pubmed.ncbi.nlm.nih.gov/34629184

Clinical and Epidemiological Profile of Breast Cancer in Mexico: Results of the Seguro Popular.

Nancy Reynoso-Noverón, Cynthia Villarreal-Garza, Enrique Soto-Perez-de-Celis...

https://pubmed.ncbi.nlm.nih.gov/29244990

Young Women With Breast Cancer in Mexico: Results of the Pilot Phase of the Joven & Fuerte Prospective Cohort.

Cynthia Villarreal-Garza, Alejandra Platas, Melina Miaja...

https://pubmed.ncbi.nlm.nih.gov/32142405

Mechanistic Targets and Nutritionally Relevant Intervention Strategies to Break Obesity-Breast Cancer Links.

Ximena M Bustamante-Marin, Jenna L Merlino, Emily Devericks...

https://pubmed.ncbi.nlm.nih.gov/33815289