Cardiometabolic Screening Program for Breast Cancer Survivors
This study is creating a screening program for breast cancer survivors to check for conditions like prediabetes, diabetes, high cholesterol (hyperlipidemia), and other heart disease risks. You might be able to join if you've had early-stage breast cancer, finished your main treatments at least three months ago, and receive care at specific Johns Hopkins breast cancer clinics. The study will involve surveys, questionnaires about your quality of life, and blood tests (HbA1c for blood sugar and a lipid panel for cholesterol). Doctors will also review your vital signs from your medical chart. The main goal is to see how common prediabetes, diabetes, and hyperlipidemia are in breast cancer survivors after three years, and to connect people with risk factors to helpful resources. The study is currently unclear on its recruitment status and plans to enroll 450 participants.
- Study design
- This is an interventional study, meaning participants will receive specific interventions like prescreening, screening, and behavioral assessments. It aims to enroll 450 participants.
- What's involved
- You would complete surveys, quality of life questionnaires, and have blood tests. Your vital signs would also be reviewed from your medical chart. If your BMI is high, you might be referred to a healthful eating and activity program.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure the prevalence of prediabetes, diabetes, and hyperlipidemia at 3 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Cardiometabolic Screening Program
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Jennifer Sheng, M.D. · PRINCIPAL_INVESTIGATOR · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Prevalence of prediabetes3 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 diabetes3 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.
- Prevalence of hyperlipidemia3 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.
- Change in HbA1cBaseline, 6 months, 12 months
The percent change in HbA1c laboratory results, at 6 and 12 months compared to baseline.
- Change in LDL cholesterolBaseline, 6 months, 12 months
The percent change in LDL cholesterol (mg/dL) laboratory results at 6 and 12 months compared to baseline.
- Prevalence of obesity/ overweightBaseline, 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 C30Baseline, 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.
- Breast-specific symptoms assessed by the of The European Organisation for Research and Treatment Cancer Quality of Life Questionnaire BR-23Baseline, 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.