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

22 de junio de 2026 actualizado por: Oluwadamilola Fayanju, MD, MA, MPHS, FACS, Abramson Cancer Center at Penn Medicine

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

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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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?

Tipo de estudio

Intervencionista

Inscripción (Estimado)

100

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Estados Unidos
    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19104
        • Reclutamiento
        • Abamson Cancer Center of the University of Pennsylvania
        • Contacto:
        • Investigador principal:
          • Margaret Pichardo, MD

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Otro: Newly diagnosed women with breast cancer
Among a sample of 100 women with newly diagnosed breast cancer, the study aims to 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 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.
Otro: 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.
Otro: 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.
Otro: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in lifestyle behavior score based
Periodo de tiempo: Baseline, 1 month, 6 months
A composite score for lifestyle behavior change consistent with the 2020 American Cancer Society (ACS) nutrition and physical activity guidelines for cancer survivors. Individual guideline components are measured as follows: Diet and alcohol intake are measured with the ASA24 dietary recall screener (a gold standard instrument) and a novel dietary screener (English/Spanish versions) instruments. Physical activity is evaluated using the Modified Global Physical Activity Questionnaire (GPAQ). Obesity is evaluated using self-reported height and weight and derived from clinical records. The composite lifestyle score will range from 0 to 8, with higher scores indicated greater adherence to the ACS lifestyle guidelines for cancer prevention.
Baseline, 1 month, 6 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Participation in biomedical research
Periodo de tiempo: Baseline
A set of questions developed by Barrett et al 2020 will be used to captures participant's Willingness to participate in future research that involves specimen donation and bio banking. This is a non-standardized tool developed from qualitative interviews. Descriptive statistics capturing the % of participants reporting yes, no or don't know will be reported.
Baseline
Financial hardship
Periodo de tiempo: Baseline, 1 month, 6 months
Financial hardship is evaluated using a set of questions developed by Nielsen et al. (Surgical Oncology, 2023). The proportion of participants reporting financial hardship will be reported.
Baseline, 1 month, 6 months
Satisfaction with novel dietary screener
Periodo de tiempo: Baseline, 1 month, 6 months
Satisfaction with novel dietary screener. This is a non-standardized instrument to evaluate satisfaction with English/Spanish dietary screeners tools. The proportion of participants reporting satisfaction with the screeners will be reported.
Baseline, 1 month, 6 months
Urinary-based Metabolites
Periodo de tiempo: Baseline, 1 month, 6 months
Urinary-based metabolites will be quantified using H NMR and LCMS technologies (targeted and untargeted).
Baseline, 1 month, 6 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Abramson Cancer Center at Penn Medicine

Colaboradores

Penn State University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

20 de enero de 2026

Finalización primaria (Estimado)

1 de diciembre de 2028

Finalización del estudio (Estimado)

1 de diciembre de 2028

Fechas de registro del estudio

Enviado por primera vez

19 de febrero de 2026

Primero enviado que cumplió con los criterios de control de calidad

16 de junio de 2026

Publicado por primera vez (Actual)

18 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

24 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

22 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • UPCC 11125
  • 858572 (Otro identificador: University of Pennsylvania IRB)

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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