NCT05386719

Cardiometabolic Screening Program

A Cardiometabolic Screening Program for Breast Cancer Survivors

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The investigators propose a prospective cardiometabolic screening program for breast cancer survivors. A formalized screening program may ensure that all patients are receiving these routine screening tests. This program could not only serve to detect prediabetes, diabetes, dyslipidemia and/or hyperlipidemia, but also direct individuals with other risk factors to community and institutional resources for management. HYPOTHESIS * Prediabetes, diabetes, dyslipidemia and overweight/obesity are prevalent in women with early stage breast cancer. * Participants that continue to participate in the study will have lower HbA1c, lower LDL, percent weight loss, and change in patient-reported outcomes (quality of life, function and symptoms) at 6 and 12 months compared to baseline. * Risk factors for cardiovascular disease (such as tobacco use, family history, hypertension) are common in breast cancer patients. * The screening program will refer patients to established institutional programs and resources (Cardiovascular Disease prevention program, Healthful Weight Eating Activity Program and Endocrinology). * The prevalence of prediabetes, diabetes and dyslipidemia in women with breast cancer will be significantly higher than healthy controls from a national database, matched for age and other comorbidities. OBJECTIVES Primary Objectives 1. To estimate the prevalence of prediabetes, diabetes, dyslipidemia and overweight/obesity in women with early stage breast cancer 2. To estimate the proportion of participants with lower HbA1c, lower LDL, percent weight loss, and change in patient-reported outcomes (quality of life, function and symptoms) at 6 and 12 months compared to baseline. Secondary Objectives 1. To estimate the prevalence of other risk factors for cardiovascular disease (tobacco use, family history, hypertension) in breast cancer patients 2. To report the number of referrals of individuals with diabetes or prediabetes or risk factors for cardiovascular disease (CVD) to established institutional programs and resources. 3. To compare the prevalence of prediabetes, diabetes and dyslipidemia in women with breast cancer with healthy controls from a national database, matched for age and other comorbidities. Exploratory 1. To assess change in HbA1c from baseline 6 and 12 months, and use of antidiabetes pharmacotherapy for patients referred to Endocrinology for diabetes management 2. To assess change in total cholesterol and LDL from baseline to 6 and 12 months, and use of statins, aspirin or antihypertensives for patients referred to CVD prevention program 3. To assess percent weight loss, and use of pharmacotherapy in patients referred to institutional weight loss program

Conditions

• Breast Cancer
• Early-stage Breast Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-06-03
• Primary completion: 2026-06-01
• Completion: 2027-06-01
• First posted: 2022-05-23
• Last updated: 2025-06-24

Locations

1 site across 1 country: United States