RecruitingNot ApplicableNCT05386719

Cardiometabolic Screening Program

A Cardiometabolic Screening Program for Breast Cancer Survivors


Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Enrollment

450 participants

Start Date

Jun 3, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria1

  • Metastatic breast cancer

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Interventions

OTHERPrescreening

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.

OTHERScreening and Enrollment

Consent

BEHAVIORALBaseline

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

BEHAVIORALInterpret BMI

Refer to Healthful Eating, Activity and Weight Program (HEAWP) if BMI ≥25 and not already on lifestyle intervention

OTHERInterpret HbA1c

HbA1c results categorized as follows: HbA1c \<5.7%; HbA1c 5.7-6.4%; HbA1c 6.5%+; or Known diabetic on medication

OTHERInterpret lipid panel and assess other risk factors

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%

BEHAVIORALAssess 10 year risk of cardiovascular event

If risk factors are present - refer to Cardiovascular Disease Prevention Program

BEHAVIORALRecommendations

Provide individual patient handout based on all above interventions

BEHAVIORALFollow-Up

6 and 12 month labs (if prior abnormal) and Patient Reported Outcome questionnaires


Locations(1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

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NCT05386719


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