Health TrialsbyHealthPanel

Cardiometabolic Screening Program

ConditionsBreast CancerEarly-stage Breast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Metastatic breast cancer

Trial design

Design model

Single group

Treatments tested in this trial

  • Prescreening

    Other intervention

    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

    Other intervention

    Consent

  • Baseline

    Behavioral

    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

    Behavioral

    Refer to Healthful Eating, Activity and Weight Program (HEAWP) if BMI ≥25 and not already on lifestyle intervention

  • Interpret HbA1c

    Other intervention

    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

    Other intervention

    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

    Behavioral

    If risk factors are present - refer to Cardiovascular Disease Prevention Program

  • Recommendations

    Behavioral

    Provide individual patient handout based on all above interventions

  • Follow-Up

    Behavioral

    6 and 12 month labs (if prior abnormal) and Patient Reported Outcome questionnaires

Treatment groups

450 Participants
are divided into 1 treatment group
Group A: Early stage breast cancer survivorsOther 9 interventions

Trial outcomes

Primary outcomes

1

Prevalence of prediabetes

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.

Time frame
3 years
2

Prevalence of diabetes

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.

Time frame
3 years
3

Prevalence of hyperlipidemia

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.

Time frame
3 years
4

Change in HbA1c

The percent change in HbA1c laboratory results, at 6 and 12 months compared to baseline.

Time frame
Baseline, 6 months, 12 months

Secondary outcomes

1

Cardiovascular risk factors (tobacco use)

The cardiovascular risk factor of tobacco use will be identified from review of medical history in electronic medical records, and surveys from participants. The proportion of patients enrolled in the study with this risk factor will be summarized descriptively.

Time frame
3 years
2

Cardiovascular risk factors (family history)

The cardiovascular risk factor of family history will be identified from review of medical history in electronic medical records, and surveys from participants. The proportion of patients enrolled in the study with this risk factor will be summarized descriptively.

Time frame
3 years
3

Cardiovascular risk factors (hypertension)

The cardiovascular risk factor of hypertension will be identified from review of medical history in electronic medical records, and surveys from participants. The proportion of patients enrolled in the study with this risk factors will be summarized descriptively.

Time frame
3 years
4

Referrals for individuals with pre-diabetes

Total number of individuals with (prediabetes) referred to established institutional programs and resources. The number of referrals overall, by disease type, and per patient will be summarized descriptively.

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead sponsor

Private Philanthropic Funds

Collaborator

Source ClinicalTrials.gov
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