450 Participants Needed

Cardiometabolic Screening for Breast Cancer Survivors

HB
SK
Overseen BySidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment for assessing 10-year cardiovascular risk in breast cancer survivors?

Research shows that breast cancer survivors have a higher risk of developing cardiometabolic issues like diabetes and high cholesterol. This suggests that regular screening and risk assessment can help manage these risks effectively.12345

Is cardiometabolic screening safe for breast cancer survivors?

The studies reviewed do not provide specific safety data for cardiometabolic screening in breast cancer survivors, but they highlight the importance of monitoring cardiometabolic risk factors like obesity, hypertension (high blood pressure), and diabetes, which are common in this group. These factors are associated with increased health risks, suggesting that screening could be beneficial for managing overall health.16789

How does the Cardiometabolic Screening and Enrollment treatment differ from other treatments for breast cancer survivors?

The Cardiometabolic Screening and Enrollment treatment is unique because it focuses on identifying and managing cardiometabolic risk factors, such as high blood pressure, diabetes, and cholesterol issues, in breast cancer survivors, which are not typically addressed by standard cancer treatments. This approach aims to improve long-term health and quality of life by preventing cardiovascular disease, a leading cause of death in these patients.16101112

What is the purpose of this trial?

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.

Research Team

JS

Jennifer Sheng, M.D.

Principal Investigator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility Criteria

This clinical trial is for early-stage breast cancer survivors who have finished their local or systemic therapy at least 3 months ago. Participants must be receiving care through specific Johns Hopkins Medical Institute locations and be able to read and speak English. Those with metastatic breast cancer cannot join.

Inclusion Criteria

I am receiving breast cancer treatment at Johns Hopkins or its associated clinics.
I finished my cancer treatment over 3 months ago.
I have been diagnosed with early stage breast cancer.

Exclusion Criteria

My breast cancer has spread to other parts of my body.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Cardiometabolic Screening Program

Implementation of a screening program for prediabetes, diabetes, dyslipidemia, and cardiovascular disease risk factors in breast cancer survivors

3 years
Regular visits as per program schedule

Follow-up

Participants are monitored for changes in HbA1c, LDL, weight, and patient-reported outcomes at 6 and 12 months

12 months
Assessments at 6 and 12 months

Referral and Management

Participants with identified risk factors are referred to community and institutional resources for management

Ongoing throughout the study

Treatment Details

Interventions

  • Assess 10 year risk of cardiovascular event
  • Baseline
  • Follow-Up
  • Interpret BMI
  • Interpret HbA1c
  • Interpret lipid panel and assess other risk factors
  • Prescreening
  • Recommendations
  • Screening and Enrollment
Trial Overview The study aims to implement a screening program for conditions like prediabetes, diabetes, dyslipidemia, hyperlipidemia, and increased cardiovascular disease risk in breast cancer survivors. It includes various assessments such as HbA1c levels, lipid panels, BMI evaluations, and cardiovascular risk predictions.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Early stage breast cancer survivorsExperimental Treatment9 Interventions
Patients with history of early stage breast cancer and at least 3 months from completion of local and systemic therapy at Johns Hopkins

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

Trials
578
Recruited
33,600+

Private Philanthropic Funds

Collaborator

Findings from Research

Breast cancer survivors have a higher risk of developing hypertension and diabetes compared to women without breast cancer, with significant differences observed after 2 years and persisting for up to 10 years.
Specific treatments, such as chemotherapy, left-sided radiation, and endocrine therapy, further increase the risk of diabetes and hypertension in breast cancer survivors, particularly among those with a normal body mass index (BMI).
Risk of Cardiometabolic Risk Factors in Women With and Without a History of Breast Cancer: The Pathways Heart Study.Kwan, ML., Cheng, RK., Iribarren, C., et al.[2023]
A new screening tool has been developed and validated to predict the risk of mortality in older cancer survivors, based on significant cardiometabolic factors such as age, sex, exercise adherence, and smoking habits, using data from 294 participants in the development cohort and 127 in the validation cohort.
The tool demonstrated acceptable discrimination and calibration, indicating it can effectively classify risk levels, but further research is needed to assess its practical application and cost-effectiveness in clinical settings.
Development and validation of a screening instrument to identify cardiometabolic predictors of mortality in older individuals with cancer: Secondary analysis of the Australian Longitudinal Study of Ageing (ALSA).Lim, E., Miller, M., Kaambwa, B., et al.[2019]
Older breast cancer survivors (n = 1361) do not have a significantly higher risk of cardiovascular disease (CVD) compared to matched women without breast cancer, indicating that breast cancer status alone is not a strong predictor of CVD risk.
The study highlights that preexisting conditions like smoking, diabetes, and hypertension are much stronger predictors of CVD risk, suggesting that managing these comorbidities is crucial for improving long-term health outcomes in breast cancer survivors.
Comorbidities and cardiovascular disease risk in older breast cancer survivors.Haque, R., Prout, M., Geiger, AM., et al.[2022]

References

Risk of Cardiometabolic Risk Factors in Women With and Without a History of Breast Cancer: The Pathways Heart Study. [2023]
Development and validation of a screening instrument to identify cardiometabolic predictors of mortality in older individuals with cancer: Secondary analysis of the Australian Longitudinal Study of Ageing (ALSA). [2019]
Comorbidities and cardiovascular disease risk in older breast cancer survivors. [2022]
Temporal patterns of chronic disease incidence after breast cancer: a nationwide population-based cohort study. [2022]
[Metabolic syndrome in postmenopausal breast cancer survivors]. [2019]
The relation between excess adiposity and breast cancer in women: Clinical implications and management. [2023]
Weight Gain after Hormone Receptor-Positive Breast Cancer. [2022]
The Living Well after Breast Cancer™ Pilot Trial: a weight loss intervention for women following treatment for breast cancer. [2022]
Cardiometabolic factors and breast cancer risk in U.S. black women. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Cardiometabolic risk factors and survival after breast cancer in the Women's Health Initiative. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Cardiometabolic Effects of Endocrine Treatment of Estrogen Receptor-Positive Early Breast Cancer. [2020]
Changes in metabolic risk, insulin resistance, leptin and adiponectin following a lifestyle intervention in overweight and obese breast cancer survivors. [2019]
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