A Mixed-Methods Metabolomics Investigation of Lifestyle and Energy Balance During Breast Cancer Survivorship
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Survey completion, Urine specimen banking, Qualitative interviews.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The MILES Study: A Mixed-Methods Metabolomics Investigation of Lifestyle and Energy Balance During Breast Cancer Survivorship
Overview
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.
Detailed description
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?
Interventions
- Other 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. - Other 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. - Other 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.
Primary outcome measures
- Change in lifestyle behavior score based [Time frame: Baseline, 1 month, 6 months]
Secondary outcome measures (4)
- Urinary-based Metabolites [Time frame: Baseline, 1 month, 6 months]
- Participation in biomedical research [Time frame: Baseline]
- Financial hardship [Time frame: Baseline, 1 month, 6 months]
- Satisfaction with novel dietary screener [Time frame: Baseline, 1 month, 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Abamson Cancer Center of the University of Pennsylvania — Philadelphia
Identifiers
NCT: NCT07655934 · UPCC 11125 · 858572