Cardiometabolic Screening Program

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.

Conditions

• Breast Cancer
• Early-stage Breast Cancer

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

Sponsors & Collaborators

• Private Philanthropic Funds

  collaborator OTHER

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  lead OTHER

Principal Investigators

• Jennifer Sheng, M.D. · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Design

Allocation

NA

Purpose

SCREENING

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-06-03

Primary Completion

2026-06-01

Completion

2027-06-01

Countries

• United States

Study Locations