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A Cardiometabolic Screening Program for Breast Cancer Survivors
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.
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
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Start Date
June 3, 2022
Primary Completion Date
June 1, 2026
Completion Date
June 1, 2027
Last Updated
June 24, 2025
450
ESTIMATED participants
Prescreening
OTHER
Screening and Enrollment
OTHER
Baseline
BEHAVIORAL
Interpret BMI
BEHAVIORAL
Interpret HbA1c
OTHER
Interpret lipid panel and assess other risk factors
OTHER
Assess 10 year risk of cardiovascular event
BEHAVIORAL
Recommendations
BEHAVIORAL
Follow-Up
BEHAVIORAL
Lead Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
NCT05245812
NCT05673200
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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