A Mixed-Methods Metabolomics Investigation of Lifestyle and Energy Balance During Breast Cancer Survivorship (MILES)
22 de junho de 2026 atualizado por: 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.
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Descrição detalhada
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?
Tipo de estudo
Intervencional
Inscrição (Estimado)
100
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Julia Lewandowski
- Número de telefone: 215-913-2031
- E-mail: Julia.lewandowski@pennmedicine.upenn.edu
Estude backup de contato
- Nome: Margaret Pichardo
- E-mail: margaret.pichardo@pennmedicine.upenn.edu
Locais de estudo
-
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- Recrutamento
- Abamson Cancer Center of the University of Pennsylvania
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Contato:
- John Plastaras, MD, PhD
- Número de telefone: 855-216-0098
- E-mail: PennCancerTrials@emergingmed.com
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Investigador principal:
- Margaret Pichardo, MD
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Outro: 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in lifestyle behavior score based
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Participation in biomedical research
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
20 de janeiro de 2026
Conclusão Primária (Estimado)
1 de dezembro de 2028
Conclusão do estudo (Estimado)
1 de dezembro de 2028
Datas de inscrição no estudo
Enviado pela primeira vez
19 de fevereiro de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
16 de junho de 2026
Primeira postagem (Real)
18 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
24 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
22 de junho de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- UPCC 11125
- 858572 (Outro identificador: University of Pennsylvania IRB)
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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