A Mixed-Methods Metabolomics Investigation of Lifestyle and Energy Balance During Breast Cancer Survivorship (MILES)
2026년 6월 22일 업데이트: 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.
연구 개요
상세 설명
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:
- What structural and interpersonal factors influence the adoption and maintenance of a healthy lifestyle after diagnosis and after each phase of treatment?
- What is the role of financial hardship on lifestyle behaviors after diagnosis?
- How do lifestyle behaviors change after surgery or systematic therapy?
- What are the barriers/facilitators to participation in urine biospecimen donation?
- Identify patient-identified strategies that would facilitate more effective translation and dissemination of lifestyle data for patients
- Promote or increase usability and promote behavior change?
- What modalities of metabolomics-based intervention delivery are best
- What is the optimal timing for intervention?
연구 유형
중재적
등록 (추정된)
100
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Julia Lewandowski
- 전화번호: 215-913-2031
- 이메일: Julia.lewandowski@pennmedicine.upenn.edu
연구 연락처 백업
- 이름: Margaret Pichardo
- 이메일: margaret.pichardo@pennmedicine.upenn.edu
연구 장소
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19104
- 모병
- Abamson Cancer Center of the University of Pennsylvania
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연락하다:
- John Plastaras, MD, PhD
- 전화번호: 855-216-0098
- 이메일: PennCancerTrials@emergingmed.com
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수석 연구원:
- Margaret Pichardo, MD
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
다른: 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.
|
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 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.
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in lifestyle behavior score based
기간: 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.
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Baseline, 1 month, 6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Participation in biomedical research
기간: Baseline
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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.
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Baseline
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Financial hardship
기간: Baseline, 1 month, 6 months
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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.
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Baseline, 1 month, 6 months
|
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Satisfaction with novel dietary screener
기간: Baseline, 1 month, 6 months
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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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Baseline, 1 month, 6 months
|
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Urinary-based Metabolites
기간: Baseline, 1 month, 6 months
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Urinary-based metabolites will be quantified using H NMR and LCMS technologies (targeted and untargeted).
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Baseline, 1 month, 6 months
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 1월 20일
기본 완료 (추정된)
2028년 12월 1일
연구 완료 (추정된)
2028년 12월 1일
연구 등록 날짜
최초 제출
2026년 2월 19일
QC 기준을 충족하는 최초 제출
2026년 6월 16일
처음 게시됨 (실제)
2026년 6월 18일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 24일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 22일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .