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

22 juni 2026 uppdaterad av: Oluwadamilola Fayanju, MD, MA, MPHS, FACS, Abramson Cancer Center at Penn Medicine

The MILES Study: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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?

Studietyp

Interventionell

Inskrivning (Beräknad)

100

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

  • Förenta staterna
    • Pennsylvania
      • Philadelphia, Pennsylvania, Förenta staterna, 19104
        • Rekrytering
        • Abamson Cancer Center of the University of Pennsylvania
        • Kontakt:
        • Huvudutredare:
          • Margaret Pichardo, MD

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Övrig: 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.
Övrig: 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.
Övrig: 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.
Övrig: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in lifestyle behavior score based
Tidsram: 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.
Baseline, 1 month, 6 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Participation in biomedical research
Tidsram: 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.
Baseline
Financial hardship
Tidsram: 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.
Baseline, 1 month, 6 months
Satisfaction with novel dietary screener
Tidsram: 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.
Baseline, 1 month, 6 months
Urinary-based Metabolites
Tidsram: Baseline, 1 month, 6 months
Urinary-based metabolites will be quantified using H NMR and LCMS technologies (targeted and untargeted).
Baseline, 1 month, 6 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Abramson Cancer Center at Penn Medicine

Samarbetspartners

Penn State University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

20 januari 2026

Primärt slutförande (Beräknad)

1 december 2028

Avslutad studie (Beräknad)

1 december 2028

Studieregistreringsdatum

Först inskickad

19 februari 2026

Först inskickad som uppfyllde QC-kriterierna

16 juni 2026

Första postat (Faktisk)

18 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

24 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

22 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • UPCC 11125
  • 858572 (Annan identifierare: University of Pennsylvania IRB)

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