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RECRUITING Not applicable ClinicalTrials.gov

Cardiometabolic Screening Program

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins • ClinicalTrials.gov ID: NCT05386719

Registry updated: 2026-09-03
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Description

This research study is being done to implement a screening program for prediabetes, diabetes, dyslipidemia and/or hyperlipidemia, and higher risk of cardiovascular disease in breast cancer survivors. This program will also help to direct individuals with risk factors to community and institutional resources for management.

Interventions

  • Prescreening (Other)
    Eligible patients (history of early stage breast cancer and at least 3 months from completion of local and systemic therapy at Johns Hopkins, reads and speaks English) complete survey for demographics, smoking status \& questions about cardiovascular disease.
  • Screening and Enrollment (Other)
    Consent
  • Baseline (Behavioral)
    Behavioral Battery and Patient Reported Outcome Quality of Life questionnaires (EORTC QLQ-C30 and QLQ-BR23) Labs (Hba1c + lipid panel if not done within 12 months or if abnormal within 1 year) Abstract vitals from chart review
  • Interpret BMI (Behavioral)
    Refer to Healthful Eating, Activity and Weight Program (HEAWP) if BMI ≥25 and not already on lifestyle intervention
  • Interpret HbA1c (Other)
    HbA1c results categorized as follows: HbA1c \<5.7%; HbA1c 5.7-6.4%; HbA1c 6.5%+; or Known diabetic on medication
  • Interpret lipid panel and assess other risk factors (Other)
    Based on above categories: HbA1c \<5.7%: Any of these cardiovascular disease risk factors: current/former tobacco use, total cholesterol \>200, family history of Coronary Artery Disease/Heart Attack in first degree family \<55 year old male or \<65 year old female, systolic blood pressure \>130 HbA1c 5.7-6.4%: Refer to Primary Care Provider and consider Healthful Eating, Activity and Weight Program (HEAWP) HbA1c 6.5%+: Refer to Endocrinology if HbA1c ≥8% Known diabetic on medication: Refer to Endocrinology if HbA1c ≥7%
  • Assess 10 year risk of cardiovascular event (Behavioral)
    If risk factors are present - refer to Cardiovascular Disease Prevention Program
  • Recommendations (Behavioral)
    Provide individual patient handout based on all above interventions
  • Follow-Up (Behavioral)
    6 and 12 month labs (if prior abnormal) and Patient Reported Outcome questionnaires

Eligibility criteria

Inclusion Criteria: * Diagnosis of early stage breast cancer * Completed local and/or systemic therapy at least 3 months ago * Receiving medical oncology care at through the breast cancer clinics at Johns Hopkins Medical Institute, including the Sidney Kimmel Comprehensive Cancer Center in Baltimore MD and Green Spring Station in Lutherville-Timonium MD, and Sibley Memorial Hospital in Washington D.C. * Read and speak English Exclusion Criteria: * Metastatic breast cancer

Conditions

Breast Cancer Early-stage Breast Cancer

Locations

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record