Breast Cancer
Conditions
Brief summary
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.
Detailed description
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?
Interventions
OTHERSurvey completion
Surveys will evaluate dietary quality, physical activity, tobacco use, demographic and socio-economic/occupation factors and perspectives about participation in biomedical/biospecimen research.
OTHERUrine 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.
OTHERQualitative 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.
Sponsors
Abramson Cancer Center at Penn Medicine
Penn State University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in lifestyle behavior score based | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urinary-based Metabolites | Baseline, 1 month, 6 months | Urinary-based metabolites will be quantified using H NMR and LCMS technologies (targeted and untargeted). |
| Participation in biomedical research | 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. |
| Financial hardship | 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. |
| Satisfaction with novel dietary screener | 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. |
Countries
United States
Contacts
CONTACTJulia Lewandowski
CONTACTMargaret Pichardo
Outcome results
None listed