Cardiometabolic Screening Program

Official title

A Cardiometabolic Screening Program for Breast Cancer Survivors

Overview

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

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 E
• 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 outcome measures

• Prevalence of prediabetes [Time frame: 3 years]
• Prevalence of diabetes [Time frame: 3 years]
• Prevalence of hyperlipidemia [Time frame: 3 years]
• Change in HbA1c [Time frame: Baseline, 6 months, 12 months]
• Change in LDL cholesterol [Time frame: Baseline, 6 months, 12 months]
• Prevalence of obesity/ overweight [Time frame: Baseline, 6 months, 12 months]
• Quality of Life Questionnaire The European Organisation for Research and Treatment Cancer C30 [Time frame: 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 [Time frame: Baseline, 6 months, 12 months]

Secondary outcome measures (9)

• Cardiovascular risk factors (tobacco use) [Time frame: 3 years]
• Cardiovascular risk factors (family history) [Time frame: 3 years]
• Cardiovascular risk factors (hypertension) [Time frame: 3 years]
• Referrals for individuals with pre-diabetes [Time frame: 3 years]
• Referrals for individuals with diabetes [Time frame: 3 years]
• Referrals for individuals with risk of cardiovascular disease [Time frame: 3 years]
• Prevalence of prediabetes in women with breast cancer versus healthy individuals [Time frame: 3 years]
• Prevalence of diabetes in women with breast cancer versus healthy individuals [Time frame: 3 years]
• Prevalence of hyperlipidemia in women with breast cancer versus healthy individuals [Time frame: 3 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Screening

Study locations

United States · 1 center

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore

Identifiers

NCT: NCT05386719 · J21125 · IRB00285627

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗