Clinical trial NCT05386719: Cardiometabolic Screening Program
Official title: A Cardiometabolic Screening Program for Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Early-stage Breast Cancer
Keywords: Survivor
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
First posted: 2022-05-23
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The screening program will refer patients to established institutional programs and resources (Cardiovascular Disease prevention program, Healthful Weight Eating Activity Program and Endocrinology).
Primary purpose: SCREENING

Brief 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

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

Primary outcomes:
measure: Prevalence of prediabetes
timeFrame: 3 years
measure: Prevalence of diabetes
timeFrame: 3 years
measure: Prevalence of hyperlipidemia
timeFrame: 3 years
measure: Change in HbA1c
timeFrame: Baseline, 6 months, 12 months
measure: Change in LDL cholesterol
timeFrame: Baseline, 6 months, 12 months
measure: Prevalence of obesity/ overweight
timeFrame: Baseline, 6 months, 12 months
measure: Quality of Life Questionnaire The European Organisation for Research and Treatment Cancer C30
timeFrame: Baseline, 6 months, 12 months
measure: Breast-specific symptoms assessed by the of The European Organisation for Research and Treatment Cancer Quality of Life Questionnaire BR-23
timeFrame: Baseline, 6 months, 12 months
Secondary outcomes:
measure: Cardiovascular risk factors (tobacco use)
timeFrame: 3 years
measure: Cardiovascular risk factors (family history)
timeFrame: 3 years
measure: Cardiovascular risk factors (hypertension)
timeFrame: 3 years
measure: Referrals for individuals with pre-diabetes
timeFrame: 3 years
measure: Referrals for individuals with diabetes
timeFrame: 3 years
measure: Referrals for individuals with risk of cardiovascular disease
timeFrame: 3 years
measure: Prevalence of prediabetes in women with breast cancer versus healthy individuals
timeFrame: 3 years
measure: Prevalence of diabetes in women with breast cancer versus healthy individuals
timeFrame: 3 years
measure: Prevalence of hyperlipidemia in women with breast cancer versus healthy individuals
timeFrame: 3 years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
Study officials:
affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
name: Jennifer Sheng, M.D.
role: PRINCIPAL_INVESTIGATOR
References: