RecruitingNCT07478016

EXploring Inflammation and Social deTerminants Study in Breast Cancer Patients

EXploring Inflammation and Social deTerminants (EXIST) Study in Breast Cancer Patients


Sponsor

Thomas Jefferson University

Enrollment

200 participants

Start Date

Dec 21, 2022

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria7

  • Female
  • \>18 years old at time of consent
  • Biopsy proven invasive breast cancer or ductal carcinoma in situ
  • Candidate has not yet received cancer therapy for their breast cancer diagnosis
  • ECOG Performance Status \< 2
  • Able to provide consent
  • Must be English speaking

Exclusion Criteria3

  • An individual who meets any of the following criteria will be excluded from participation in this study:
  • Patient has started therapy or already had definitive oncologic surgery
  • Another malignancy within the past 6 months that was not a non-melanomatous skin lesion

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.


Locations(1)

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, United States

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NCT07478016


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