Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
450 participants
INTERVENTIONAL
2022-06-03
2027-06-01
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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Early stage breast cancer survivors
Patients with history of early stage breast cancer and at least 3 months from completion of local and systemic therapy at Johns Hopkins
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.
Screening and Enrollment
Consent
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
Interpret BMI
Refer to Healthful Eating, Activity and Weight Program (HEAWP) if BMI ≥25 and not already on lifestyle intervention
Interpret HbA1c
HbA1c results categorized as follows:
HbA1c \<5.7%; HbA1c 5.7-6.4%; HbA1c 6.5%+; or Known diabetic on medication
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%
Assess 10 year risk of cardiovascular event
If risk factors are present - refer to Cardiovascular Disease Prevention Program
Recommendations
Provide individual patient handout based on all above interventions
Follow-Up
6 and 12 month labs (if prior abnormal) and Patient Reported Outcome questionnaires
Interventions
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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.
Screening and Enrollment
Consent
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
Interpret BMI
Refer to Healthful Eating, Activity and Weight Program (HEAWP) if BMI ≥25 and not already on lifestyle intervention
Interpret HbA1c
HbA1c results categorized as follows:
HbA1c \<5.7%; HbA1c 5.7-6.4%; HbA1c 6.5%+; or Known diabetic on medication
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%
Assess 10 year risk of cardiovascular event
If risk factors are present - refer to Cardiovascular Disease Prevention Program
Recommendations
Provide individual patient handout based on all above interventions
Follow-Up
6 and 12 month labs (if prior abnormal) and Patient Reported Outcome questionnaires
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Private Philanthropic Funds
OTHER
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
OTHER
Responsible Party
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Principal Investigators
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Jennifer Sheng, M.D.
Role: PRINCIPAL_INVESTIGATOR
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Locations
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Countries
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Central Contacts
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Role: CONTACT
Facility Contacts
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Vered Stearns, MD
Role: primary
Other Identifiers
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IRB00285627
Identifier Type: OTHER
Identifier Source: secondary_id
J21125
Identifier Type: -
Identifier Source: org_study_id
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