A Cardiometabolic Screening Program for Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 450
- 试验地点
- 2
- 主要终点
- Change in LDL cholesterol
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Metastatic breast cancer
研究组 & 干预措施
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
干预措施: Prescreening (Other)
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
干预措施: Baseline (Behavioral)
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
干预措施: Interpret BMI (Behavioral)
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
干预措施: Interpret lipid panel and assess other risk factors (Other)
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
干预措施: Screening and Enrollment (Other)
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
干预措施: Assess 10 year risk of cardiovascular event (Behavioral)
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
干预措施: Interpret HbA1c (Other)
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
干预措施: Recommendations (Behavioral)
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
干预措施: Follow-Up (Behavioral)
结局指标
主要结局
Change in LDL cholesterol
时间窗: Baseline, 6 months, 12 months
The percent change in LDL cholesterol (mg/dL) laboratory results at 6 and 12 months compared to baseline.
Prevalence of prediabetes
时间窗: 3 years
The proportion of women with early stage breast cancer who have prediabetes: The number is determined through medical history, laboratory results, and baseline survey. Prevalence of prediabetes, will be estimated with an exact 95% confidence interval.
Prevalence of diabetes
时间窗: 3 years
The proportion of women with early stage breast cancer who have diabetes: The number is determined through medical history, laboratory results, and baseline survey. Prevalence of diabetes, will be estimated with an exact 95% confidence interval.
Change in HbA1c
时间窗: Baseline, 6 months, 12 months
The percent change in HbA1c laboratory results, at 6 and 12 months compared to baseline.
Prevalence of obesity/ overweight
时间窗: Baseline, 6 months, 12 months
The proportion of women with early stage breast cancer with BMI \>/= 25kg/mg squared. Body Mass Index (BMI) as recorded in participant electronic medical record will be evaluated to determine the percent change in Body Mass Index from baseline at 6 and 12 months.
Quality of Life Questionnaire The European Organisation for Research and Treatment Cancer C30
时间窗: Baseline, 6 months, 12 months
Participants will complete the Quality of Life Questionnaire C30 The Quality of Life Questionnaire-C30, which includes 30 items. The 30 items assess physical, role, emotional, cognitive and social functioning, global health status or Quality Of Life scales, fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties. The Quality of Life Questionnaire-C30 is scored on the basis of classical test theory (CTT), and uses the total item score as the scale score. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the patient), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the patient). The percent change in Patient Reported Outcome scores from baseline is accessed at 6 months and 12 months.
Prevalence of hyperlipidemia
时间窗: 3 years
The proportion of women with early stage breast cancer with hyperlipidemia as determined by medical history and laboratory results. Prevalence of hyperlipidemia will be estimated with an exact 95% confidence interval.
Breast-specific symptoms assessed by the of The European Organisation for Research and Treatment Cancer Quality of Life Questionnaire BR-23
时间窗: Baseline, 6 months, 12 months
Participants to complete the EORTC Quality of Life Questionnaire-BR23. The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-BR23 has demonstrated validity and reliability as a quality of life questionnaires specific for breast cancer. The EORTC QLQ-BR23 is a breast-specific module that comprises of 23 questions to assess body image, sexual functioning, sexual enjoyment, future perspective, systemic therapy side effects, breast symptoms, arm symptoms and upset by hair loss. The scoring approach for the QLQ-BR23 is identical to QLQ-C30. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the patient), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state). The percent change in scores from baseline is assessed at 6 months and 12 months.
次要结局
- Referrals for individuals with diabetes(3 years)
- Cardiovascular risk factors (family history)(3 years)
- Cardiovascular risk factors (tobacco use)(3 years)
- Cardiovascular risk factors (hypertension)(3 years)
- Referrals for individuals with pre-diabetes(3 years)
- Prevalence of diabetes in women with breast cancer versus healthy individuals(3 years)
- Referrals for individuals with risk of cardiovascular disease(3 years)
- Prevalence of prediabetes in women with breast cancer versus healthy individuals(3 years)
- Prevalence of hyperlipidemia in women with breast cancer versus healthy individuals(3 years)