Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

450

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline

13mo left

Started Jun 2022

Longer than P75 for not_applicable breast-cancer

Geographic Reach

1 country

1 active site

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

5 years study duration

Study Progress79%

Jun 2022Jun 2027

First Submitted

Initial submission to the registry

May 18, 2022

Completed

5 days until next milestone

First Posted

Study publicly available on registry

May 23, 2022

Completed

11 days until next milestone

Study Start

First participant enrolled

June 3, 2022

Completed

4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

June 24, 2025

Status Verified

June 1, 2025

Enrollment Period

4 years

First QC Date

May 18, 2022

Last Update Submit

June 18, 2025

Conditions

Breast Cancer Early-stage Breast Cancer

Keywords

Survivor

Outcome Measures

Primary Outcomes (8)

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.
3 years
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.
3 years
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.
3 years
Change in HbA1c
The percent change in HbA1c laboratory results, at 6 and 12 months compared to baseline.
Baseline, 6 months, 12 months
Change in LDL cholesterol
The percent change in LDL cholesterol (mg/dL) laboratory results at 6 and 12 months compared to baseline.
Baseline, 6 months, 12 months
Prevalence of obesity/ overweight
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.
Baseline, 6 months, 12 months
Quality of Life Questionnaire The European Organisation for Research and Treatment Cancer C30
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.
Baseline, 6 months, 12 months
Breast-specific symptoms assessed by the of The European Organisation for Research and Treatment Cancer Quality of Life Questionnaire BR-23
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.
Baseline, 6 months, 12 months

Secondary Outcomes (9)

Cardiovascular risk factors (tobacco use)
3 years
Cardiovascular risk factors (family history)
3 years
Cardiovascular risk factors (hypertension)
3 years
Referrals for individuals with pre-diabetes
3 years
Referrals for individuals with diabetes
3 years
+4 more secondary outcomes

Study Arms (1)

Early stage breast cancer survivors

OTHER

Patients with history of early stage breast cancer and at least 3 months from completion of local and systemic therapy at Johns Hopkins

Other: PrescreeningOther: Screening and EnrollmentBehavioral: BaselineBehavioral: Interpret BMIOther: Interpret HbA1cOther: Interpret lipid panel and assess other risk factorsBehavioral: Assess 10 year risk of cardiovascular eventBehavioral: RecommendationsBehavioral: Follow-Up

Interventions

PrescreeningOTHER

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.