EXploring Inflammation and Social deTerminants (EXIST) Study in Breast Cancer Patients
Thomas Jefferson University
Summary
This is a pilot trial to assess how measures of inflammation are correlated with Social Determinants of Health (SDoH) in breast cancer patients. Expected duration of subject participation is one single time point. The patients will fill out questionnaires and provide a plasma sample.
Description
OBJECTIVE: To understand the link between adverse Social Determinants of Health (SDoH) on inflammation, a known contributor to cancer progression and metastases. PRIMARY: Patients with newly diagnosed, biopsy proven breast cancer will be screened for SDoH and distress via a distress screen and for biomarkers. The primary endpoint will be to understand the relationship between measured social determinants of health and inflammation as found in the plasma and buffy coat sample. SDoH will be evaluated as per the Centers for Medicare and Medicaid Services (CMS) survey. This survey was chosen du…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Individuals must meet all the following inclusion criteria to be eligible to participate in the study: 1. Female 2. \>18 years old at time of consent 3. Biopsy proven invasive breast cancer or ductal carcinoma in situ 4. Candidate has not yet received cancer therapy for their breast cancer diagnosis 5. ECOG Performance Status \< 2 6. Able to provide consent 7. Must be English speaking Exclusion Criteria: * An individual who meets any of the following criteria will be excluded from participation in this study: 1. Patient has started therapy or already…
Interventions
- OtherSurvey Assessments
The CMS Social Determinant of Health (SDOH) Survey refers to CMS's standardized screening tool used to identify patient needs related to housing, food, transportation, utilities, and safety. It helps providers address non-medical barriers to care and improve health outcomes by documenting social risk factors in a consistent manner. The NCCN Distress Thermometer and Problem List is a screening tool developed by the National Comprehensive Cancer Network (NCCN) to help identify and assess distress in people with cancer. It includes a 0-10 distress rating scale and a Problem List that allows patients to indicate specific practical, emotional, physical, social, and spiritual concerns contributing to their distress.
- OtherDiet Recall
A diet recall is a nutrition assessment method where an individual reports all foods and beverages consumed over a specific period, most commonly the previous 24 hours. It captures detailed information-such as portion sizes, preparation methods, and timing-to help clinicians or researchers evaluate dietary intake and identify nutritional patterns or deficiencies
- OtherBlood Biomarker Collection
The blood specimens will be processed for plasma and buffy coat.
Location
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityPhiladelphia, Pennsylvania