Cardiometabolic Screening Program (NCT05386719) | Clinical Trial Compass
RecruitingNot Applicable
Cardiometabolic Screening Program
United States450 participantsStarted 2022-06-03
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Prevalence of prediabetes
Timeframe: 3 years
2
Prevalence of diabetes
Timeframe: 3 years
3
Prevalence of hyperlipidemia
Timeframe: 3 years
4
Change in HbA1c
Timeframe: Baseline, 6 months, 12 months
5
Change in LDL cholesterol
Timeframe: Baseline, 6 months, 12 months
6
Prevalence of obesity/ overweight
Timeframe: Baseline, 6 months, 12 months
7
Quality of Life Questionnaire The European Organisation for Research and Treatment Cancer C30
Timeframe: Baseline, 6 months, 12 months
8
Breast-specific symptoms assessed by the of The European Organisation for Research and Treatment Cancer Quality of Life Questionnaire BR-23
Trial details
NCT IDNCT05386719
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins