A Mixed-Methods Metabolomics Investigation of Lifestyle and Energy Balance During Breast Cancer Survivorship (MILES)
2026年6月22日 更新者：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.
研究概览
详细说明
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?
研究类型
介入性
注册 (估计的)
100
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Julia Lewandowski
- 电话号码：215-913-2031
- 邮箱：Julia.lewandowski@pennmedicine.upenn.edu
研究联系人备份
- 姓名：Margaret Pichardo
- 邮箱：margaret.pichardo@pennmedicine.upenn.edu
学习地点
-
-
Pennsylvania
-
Philadelphia、Pennsylvania、美国、19104
- 招聘中
- Abamson Cancer Center of the University of Pennsylvania
-
接触：
- John Plastaras, MD, PhD
- 电话号码：855-216-0098
- 邮箱：PennCancerTrials@emergingmed.com
-
首席研究员：
- Margaret Pichardo, MD
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in lifestyle behavior score based
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Participation in biomedical research
大体时间：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
大体时间：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
大体时间：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
大体时间：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
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年1月20日
初级完成 (估计的)
2028年12月1日
研究完成 (估计的)
2028年12月1日
研究注册日期
首次提交
2026年2月19日
首先提交符合 QC 标准的
2026年6月16日
首次发布 (实际的)
2026年6月18日
研究记录更新
最后更新发布 (实际的)
2026年6月24日
上次提交的符合 QC 标准的更新
2026年6月22日
最后验证
2026年6月1日
更多信息
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