Cardiometabolic Screening Program

Johns Hopkins Medicine

Status: Enrolling

Conditions: Breast Cancer; Early-stage Breast Cancer

Treatments: Other: Interpret lipid panel and assess other risk factors; Other: Prescreening; Other: Interpret HbA1c; Behavioral: Interpret BMI; Behavioral: Follow-Up; Other: Screening and Enrollment; Behavioral: Recommendations; Behavioral: Baseline; Behavioral: Assess 10 year risk of cardiovascular event

Study type: Interventional

Funder types: Other

Identifiers

NCT05386719

IRB00285627 (Other Identifier)

J21125

Details and patient eligibility

About

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.

Full 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

Enrollment: 450 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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450 participants in 1 patient group

Early stage breast cancer survivors

Other group

Description:

Patients with history of early stage breast cancer and at least 3 months from completion of local and systemic therapy at Johns Hopkins

Treatment:

Behavioral: Assess 10 year risk of cardiovascular event

Behavioral: Recommendations

Behavioral: Baseline

Other: Screening and Enrollment

Behavioral: Follow-Up

Behavioral: Interpret BMI

Other: Interpret HbA1c

Other: Interpret lipid panel and assess other risk factors

Other: Prescreening