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

NCT07655934 | Recruiting

• 2 other identifiers: UPCC 11125858572
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 1 month, 6 months

Secondary Outcomes (4)

• Urinary-based Metabolites

  Baseline, 1 month, 6 months

• Participation in biomedical research

  Baseline

• Financial hardship

  Baseline, 1 month, 6 months

• Satisfaction with novel dietary screener

  Baseline, 1 month, 6 months

Study Arms (1)

Newly diagnosed women with breast cancer

OTHER

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.

Other: Survey completion; Other: Urine specimen banking; Other: Qualitative interviews

Interventions

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.

Newly diagnosed women with breast cancer

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.

Newly diagnosed women with breast cancer

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.

Newly diagnosed women with breast cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• Penn State University: collaborator

Study Sites (1)

Abamson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Julia Lewandowski

CONTACT

215-913-2031; Julia.lewandowski@pennmedicine.upenn.edu

Margaret Pichardo

CONTACT

margaret.pichardo@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of Breast Surgery

Study Record Dates

• First Submitted: February 19, 2026
• First Posted: June 18, 2026
• Study Start: January 20, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 24, 2026

Record last verified: 2026-06

Locations

US (1)