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NCT Number: NCT07655934

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Abamson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location status: Recruiting

Location contact

John Plastaras, MD, PhD

CONTACT

[email protected]

855-216-0098

Margaret Pichardo, MD

PRINCIPAL_INVESTIGATOR

About this study

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:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Survey Completion

Other

Surveys will evaluate dietary quality, physical activity, tobacco use, demographic and socio-economic/occupation factors and perspectives about participation in biomedical/biospecimen research.

Urine specimen banking

Other

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.

Qualitative Interviews

Other

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.

Primary outcomes

  1. Change in lifestyle behavior score based

    Time frame: 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.

Secondary outcomes

  1. Urinary-based Metabolites

    Time frame: Baseline, 1 month, 6 months

    Urinary-based metabolites will be quantified using H NMR and LCMS technologies (targeted and untargeted).

  2. Participation in biomedical research

    Time frame: 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.

  3. Financial hardship

    Time frame: 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.

  4. Satisfaction with novel dietary screener

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Julia Lewandowski

CONTACT

[email protected]

215-913-2031

Margaret Pichardo

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Collaborators

  • Penn State University

Registry information

Official study title

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

Acronym: MILES

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 18, 2026
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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