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.
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
Women age less than 18 years
Women without a new primary breast cancer diagnosis
Women who are pregnant
Single group
Survey completion
Other interventionSurveys 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 interventionThe 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 interventionAfter 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.
Change in lifestyle behavior score based
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.
Urinary-based Metabolites
Urinary-based metabolites will be quantified using H NMR and LCMS technologies (targeted and untargeted).
Participation in biomedical research
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.
Financial hardship
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.
Satisfaction with novel dietary screener
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.
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Abramson Cancer Center at Penn Medicine
Lead sponsor
Penn State University
Collaborator
