A Mixed-Methods Metabolomics Investigation of Lifestyle and Energy Balance During Breast Cancer Survivorship

Официальное название

The MILES Study: A Mixed-Methods Metabolomics Investigation of Lifestyle and Energy Balance During Breast Cancer Survivorship

Обзор

The MILES Study is a longitudinal, mixed-methods investigation of urinary biomarkers, energy balance, and lifestyle modifications in diverse women during early breast cancer treatment. The study's overarching goal is to assess dietary quality and physical activity changes over time using reliable, scalable tools suitable for clinical or population settings, supporting newly diagnosed patients in adopting and maintaining healthy behaviors through treatment and survivorship.

Подробное описание

Quantitative intervention: The study team will recruit adult women (age 18 years or older), who can read English or Spanish, have received a new diagnosis of breast cancer (stage 0-III) in the past 60 days, and have been scheduled to consult with a Penn surgeon.

Among a sample of 100 women with newly diagnosed breast cancer, the study team will collect novel lifestyle behavior data across three time points-at diagnosis, 1 month after surgery, and 6 months after surgery. Surveys will evaluate dietary quality, physical activity, tobacco use, demographic and socio-economic/occupation factors and perspectives about participation in biomedical/biospecimen research. The study team will also collect the first urine of the day from these volunteers on the same day that they complete the lifestyle questionnaires. The urine will be used for metabolomics testing via Nuclear Magnetic Resonance (NMR) spectroscopy and will be correlated with the survey data.

Qualitative intervention: Among a subset of 50 women, the study team will conduct semi-structured interviews at baseline and at follow-up to answer the following research questions:

1. What structural and interpersonal factors influence the adoption and maintenance of a healthy lifestyle after diagnosis and after each phase of treatment? 2. What is the role of financial hardship on lifestyle behaviors after diagnosis? 3. How do lifestyle behaviors change after surgery or systematic therapy? 4. What are the barriers/facilitators to participation in urine biospecimen donation? 5. Identify patient-identified strategies that would facilitate more effective translation and dissemination of lifestyle data for patients 6. Promote or increase usability and promote behavior change? 7. What modalities of metabolomics-based intervention delivery are best 8. What is the optimal timing for intervention?

Вмешательства

• Другое Survey completion
  Surveys will evaluate dietary quality, physical activity, tobacco use, demographic and socio-economic/occupation factors and perspectives about participation in biomedical/biospecimen research.
• Другое Urine specimen banking
  The study team will collect the first urine of the day from these volunteers on the same day that they complete the lifestyle questionnaires. The urine will be used for metabolomics testing via Nuclear Magnetic Resonance (NMR) spectroscopy and will be correlated with the survey data.
• Другое Qualitative interviews
  After the survey and urine specimen have been received, participants will be scheduled for online or in-person semi-structured interviews. Semi-structured interviews will be conducted at baseline (either before or after surgery, but not both for the same individual) and at follow up.

Первичные конечные точки

• Change in lifestyle behavior score based [Срок оценки: Baseline, 1 month, 6 months]

Вторичные конечные точки (4)

• Urinary-based Metabolites [Срок оценки: Baseline, 1 month, 6 months]
• Participation in biomedical research [Срок оценки: Baseline]
• Financial hardship [Срок оценки: Baseline, 1 month, 6 months]
• Satisfaction with novel dietary screener [Срок оценки: Baseline, 1 month, 6 months]

Критерии участия

Критерии включения

• Adult women (age 18 years or older)
• Able to read English or Spanish
• Newly diagnosed with primary stage 0, I, II, or III breast cancer
• Pathological diagnosis within the previous 60 days
• Scheduled to have surgery with a Penn Medicine surgeon

Критерии исключения

• Women age less than 18 years
• Women without a new primary breast cancer diagnosis
• Women who are pregnant

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Abamson Cancer Center of the University of Pennsylvania — Philadelphia

Идентификаторы

NCT: NCT07655934 · UPCC 11125 · 858572

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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