Cardiometabolic Screening Program

Conditions studied

Breast Cancer, Early-stage Breast Cancer

About this study

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

• Other: Prescreening — 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.
• Other: Screening and Enrollment — Consent
• Behavioral: Baseline — 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
• Behavioral: Interpret BMI — Refer to Healthful Eating, Activity and Weight Program (HEAWP) if BMI ≥25 and not already on lifestyle intervention
• Other: Interpret HbA1c — HbA1c results categorized as follows: HbA1c \<5.7%; HbA1c 5.7-6.4%; HbA1c 6.5%+; or Known diabetic on medication
• Other: Interpret 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%
• Behavioral: Assess 10 year risk of cardiovascular event — If risk factors are present - refer to Cardiovascular Disease Prevention Program
• Behavioral: Recommendations — Provide individual patient handout based on all above interventions
• Behavioral: Follow-Up — 6 and 12 month labs (if prior abnormal) and Patient Reported Outcome questionnaires

Primary outcomes

• Prevalence of prediabetes (3 years)
• Prevalence of diabetes (3 years)
• Prevalence of hyperlipidemia (3 years)
• Change in HbA1c (Baseline, 6 months, 12 months)
• Change in LDL cholesterol (Baseline, 6 months, 12 months)
• Prevalence of obesity/ overweight (Baseline, 6 months, 12 months)
• Quality of Life Questionnaire The European Organisation for Research and Treatment Cancer C30 (Baseline, 6 months, 12 months)
• Breast-specific symptoms assessed by the of The European Organisation for Research and Treatment Cancer Quality of Life Questionnaire BR-23 (Baseline, 6 months, 12 months)

Eligibility information

Study locations

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland 21231-1000 United States