Recruiting

Observational Study

Sponsor:

Abramson Cancer Center at Penn Medicine

Code:

NCT07655934

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Survey completion

Urine specimen banking

Qualitative interviews

Study Details

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

Study ID

NCT07655934

Start date

Jan 20, 2026

Status verified date

Jun, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

other: 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.

Interventions

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.

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.

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 measure

  • Change in lifestyle behavior score based [ Time Frame: Baseline, 1 month, 6 months ]

Central Contacts and Locations

Central contacts

Julia Lewandowski

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

Margaret Pichardo

margaret.pichardo@pennmedicine.upenn.edu

Locations

Abamson Cancer Center of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

John Plastaras, MD, PhD

855-216-0098PennCancerTrials@emergingmed.com

Principal Investigator:

Margaret Pichardo, MD

More Information

Sponsor

Abramson Cancer Center at Penn Medicine

Last update posted

Jun 24, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Abramson Cancer Center at Penn Medicine on 2026-06-24.