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.
調査の概要
詳細な説明
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?
研究の種類
介入
入学 (推定)
100
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Julia Lewandowski
- 電話番号：215-913-2031
- メール：Julia.lewandowski@pennmedicine.upenn.edu
研究連絡先のバックアップ
- 名前：Margaret Pichardo
- メール：margaret.pichardo@pennmedicine.upenn.edu
研究場所
-
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19104
- 募集
- Abamson Cancer Center of the University of Pennsylvania
-
コンタクト：
- John Plastaras, MD, PhD
- 電話番号：855-216-0098
- メール：PennCancerTrials@emergingmed.com
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主任研究者：
- Margaret Pichardo, MD
-
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in lifestyle behavior score based
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Participation in biomedical research
時間枠：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
|
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Financial hardship
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年1月20日
一次修了 (推定)
2028年12月1日
研究の完了 (推定)
2028年12月1日
試験登録日
最初に提出
2026年2月19日
QC基準を満たした最初の提出物
2026年6月16日
最初の投稿 (実際)
2026年6月18日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月24日
QC基準を満たした最後の更新が送信されました
2026年6月22日
最終確認日
2026年6月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。