Breast CancerNCT05386719
Cardiometabolic Screening Program
A study testing Prescreening, Screening and Enrollment and Baseline in people with Breast Cancer and Early-stage Breast Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Early-stage Breast Cancer
- What is being tested?
- Prescreening, Screening and Enrollment and Baseline
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2022to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Metastatic breast cancer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-1000
Vered Stearns, MD, 443-287-6547
About this study
Official title: A Cardiometabolic Screening Program for Breast Cancer Survivors
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.
Read the detailed description
The investigators propose a prospective cardiometabolic screening program for breast cancer survivors. A formalized screening program may ensure that all patients are receiving these routine screening tests. This program could not only serve to detect prediabetes, diabetes, dyslipidemia and/or hyperlipidemia, but also direct individuals with other risk factors to community and institutional resources for management.
HYPOTHESIS
- Prediabetes, diabetes, dyslipidemia and overweight/obesity are prevalent in women with early stage breast cancer.
- Participants that continue to participate in the study will have lower HbA1c, lower LDL, percent weight loss, and change in patient-reported outcomes (quality of life, function and symptoms) at 6 and 12 months compared to baseline.
- Risk factors for cardiovascular disease (such as tobacco use, family history, hypertension) are common in breast cancer patients.
- The screening program will refer patients to established institutional programs and resources (Cardiovascular Disease prevention program, Healthful Weight Eating Activity Program and Endocrinology).
- The prevalence of prediabetes, diabetes and dyslipidemia in women with breast cancer will be significantly higher than healthy controls from a national database, matched for age and other comorbidities.
OBJECTIVES
Primary Objectives
- To estimate the prevalence of prediabetes, diabetes, dyslipidemia and overweight/obesity in women with early stage breast cancer
- To estimate the proportion of participants with lower HbA1c, lower LDL, percent weight loss, and change in patient-reported outcomes (quality of life, function and symptoms) at 6 and 12 months compared to baseline.
Secondary Objectives
- To estimate the prevalence of other risk factors for cardiovascular disease (tobacco use, family history, hypertension) in breast cancer patients
- To report the number of referrals of individuals with diabetes or prediabetes or risk factors for cardiovascular disease (CVD) to established institutional programs and resources.
- To compare the prevalence of prediabetes, diabetes and dyslipidemia in women with breast cancer with healthy controls from a national database, matched for age and other comorbidities.
Exploratory
- To assess change in HbA1c from baseline 6 and 12 months, and use of antidiabetes pharmacotherapy for patients referred to Endocrinology for diabetes management
- To assess change in total cholesterol and LDL from baseline to 6 and 12 months, and use of statins, aspirin or antihypertensives for patients referred to CVD prevention program
- To assess percent weight loss, and use of pharmacotherapy in patients referred to institutional weight loss program
- Conditions
- Breast Cancer, Early-stage Breast Cancer
- Being tested
- Prescreening, Screening and Enrollment, Baseline, Interpret BMI, Interpret HbA1c
- Keywords
- Survivor
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Screening and EnrollmentOther
Consent
BaselineBehavioural
Also called Patient- reported outcomes questionnaires, labs, vitals results
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 BMIBehavioural
Refer to Healthful Eating, Activity and Weight Program (HEAWP) if BMI ≥25 and not already on lifestyle intervention
Interpret HbA1cOther
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 factorsOther
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 eventBehavioural
If risk factors are present - refer to Cardiovascular Disease Prevention Program
RecommendationsBehavioural
Provide individual patient handout based on all above interventions
Follow-UpBehavioural
6 and 12 month labs (if prior abnormal) and Patient Reported Outcome questionnaires
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Prescreening; Other: Screening and Enrollment; Behavioral: Baseline; Behavioral: Interpret BMI; Other: Interpret HbA1c; Other: Interpret lipid panel and assess other risk factors; Behavioral: Assess 10 year risk of cardiovascular event; Behavioral: Recommendations; Behavioral: Follow-Up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 3 years
Change in HbA1c
The percent change in HbA1c laboratory results, at 6 and 12 months compared to baseline.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 6 months, 12 months
Secondary outcomes (9)
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.
Measured: 3 years
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.
Measured: 3 years
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.
Measured: 3 years
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.
Measured: 3 years
Referrals for individuals with diabetes
Total number of individuals with diabetes referred to established institutional programs and resources. The number of referrals overall, by disease type, and per patient will be summarized descriptively.
Measured: 3 years
Referrals for individuals with risk of cardiovascular disease
Total number of individuals with risk factors for cardiovascular disease referred to established institutional programs and resources. The number of referrals by disease type, and per patient will be summarized descriptively.
Measured: 3 years
Prevalence of prediabetes in women with breast cancer versus healthy individuals
Compare the prevalence of prediabetes in women with breast cancer versus healthy controls from a national database, controlling for age and other confounding factors. The investigators will obtain access to a national database that provides information on the incidence of prediabetes, diabetes, hyperlipidemia, and history of breast cancer. The investigators will compare the expected number of incident cases of prediabetes to the observed number in The investigators' cohort, adjusting for age and race.
Measured: 3 years
Prevalence of diabetes in women with breast cancer versus healthy individuals
Prevalence of of diabetes in women with breast cancer versus healthy controls from a national database, controlling for age and other confounding factors. The investigators will obtain access to a national database that provides information on the incidence of prediabetes, diabetes, hyperlipidemia, and history of breast cancer. The investigators will compare the expected number of incident cases of diabetes to the observed number in The investigators' cohort, adjusting for age and race.
Measured: 3 years
Prevalence of hyperlipidemia in women with breast cancer versus healthy individuals
Prevalence of hyperlipidemia in women with breast cancer versus healthy controls from a national database, controlling for age and other confounding factors. The investigators will obtain access to a national database that provides information on the incidence of prediabetes, diabetes, hyperlipidemia, and history of breast cancer. The investigators will compare the expected number of incident cases of hyperlipidemia to the observed number in The investigators cohort, adjusting for age and race.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start3 Jun 2022
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The screening program will refer patients to established institutional programs and resources (Cardiovascular Disease prevention program, Healthful Weight Eating Activity Program and Endocrinology).
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Sponsor type
- University, hospital or other
- Collaborators
- Private Philanthropic Funds
- Responsible party
- Sponsor
- Investigators
- Jennifer Sheng, M.D., Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05386719
- Sponsor's protocol ID
- J21125
- Other IDs
- IRB00285627
- Status last verified
- Sep 2026
- First submitted
- 18 May 2022
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cardiometabolic Screening Program for Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT05386719
- Acronym / sponsor ID
- J21125
- Conditions
- Breast Cancer, Early-stage Breast Cancer
- Keywords
- Survivor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Private Philanthropic Funds
- Study start
- 3 Jun 2022 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 23 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigators propose a prospective cardiometabolic screening program for breast cancer survivors. A formalized screening program may ensure that all patients are receiving these routine screening tests. This program could not only serve to detect prediabetes, diabetes, dyslipidemia and/or hyperlipidemia, but also direct individuals with other risk factors to community and institutional resources for management.
HYPOTHESIS
- Prediabetes, diabetes, dyslipidemia and overweight/obesity are prevalent in women with early stage breast cancer.
- Participants that continue to participate in the study will have lower HbA1c, lower LDL, percent weight loss, and change in patient-reported outcomes (quality of life, function and symptoms) at 6 and 12 months compared to baseline.
- Risk factors for cardiovascular disease (such as tobacco use, family history, hypertension) are common in breast cancer patients.
- The screening program will refer patients to established institutional programs and resources (Cardiovascular Disease prevention program, Healthful Weight Eating Activity Program and Endocrinology).
- The prevalence of prediabetes, diabetes and dyslipidemia in women with breast cancer will be significantly higher than healthy controls from a national database, matched for age and other comorbidities.
OBJECTIVES
Primary Objectives
- To estimate the prevalence of prediabetes, diabetes, dyslipidemia and overweight/obesity in women with early stage breast cancer
- To estimate the proportion of participants with lower HbA1c, lower LDL, percent weight loss, and change in patient-reported outcomes (quality of life, function and symptoms) at 6 and 12 months compared to baseline.
Secondary Objectives
- To estimate the prevalence of other risk factors for cardiovascular disease (tobacco use, family history, hypertension) in breast cancer patients
- To report the number of referrals of individuals with diabetes or prediabetes or risk factors for cardiovascular disease (CVD) to established institutional programs and resources.
- To compare the prevalence of prediabetes, diabetes and dyslipidemia in women with breast cancer with healthy controls from a national database, matched for age and other comorbidities.
Exploratory
- To assess change in HbA1c from baseline 6 and 12 months, and use of antidiabetes pharmacotherapy for patients referred to Endocrinology for diabetes management
- To assess change in total cholesterol and LDL from baseline to 6 and 12 months, and use of statins, aspirin or antihypertensives for patients referred to CVD prevention program
- To assess percent weight loss, and use of pharmacotherapy in patients referred to institutional weight loss program
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The screening program will refer patients to established institutional programs and resources (Cardiovascular Disease prevention program, Healthful Weight Eating Activity Program and Endocrinology).
| Arm | Type | Receives |
|---|---|---|
| Early stage breast cancer survivors | Other | Other: Prescreening, Other: Screening and Enrollment, Behavioral: Baseline, Behavioral: Interpret BMI, Other: Interpret HbA1c, Other: Interpret lipid panel and assess other risk factors, Behavioral: Assess 10 year risk of cardiovascular event, Behavioral: Recommendations, Behavioral: Follow-UpPatients with history of early stage breast cancer and at least 3 months from completion of local and systemic therapy at Johns Hopkins |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Metastatic breast cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrescreeningEligible 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. | Other | Early stage breast cancer survivors |
| Screening and EnrollmentConsent | Other | Early stage breast cancer survivors |
| BaselineAlso: Patient- reported outcomes questionnaires, labs, vitals resultsBehavioral 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 | Behavioural | Early stage breast cancer survivors |
| Interpret BMIRefer to Healthful Eating, Activity and Weight Program (HEAWP) if BMI ≥25 and not already on lifestyle intervention | Behavioural | Early stage breast cancer survivors |
| Interpret HbA1cHbA1c results categorized as follows: HbA1c <5.7%; HbA1c 5.7-6.4%; HbA1c 6.5%+; or Known diabetic on medication | Other | Early stage breast cancer survivors |
| Interpret lipid panel and assess other risk factorsBased 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% | Other | Early stage breast cancer survivors |
| Assess 10 year risk of cardiovascular eventIf risk factors are present - refer to Cardiovascular Disease Prevention Program | Behavioural | Early stage breast cancer survivors |
| RecommendationsProvide individual patient handout based on all above interventions | Behavioural | Early stage breast cancer survivors |
| Follow-Up6 and 12 month labs (if prior abnormal) and Patient Reported Outcome questionnaires | Behavioural | Early stage breast cancer survivors |
Primary outcome
Prevalence of prediabetes
Time frame: 3 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 diabetes
Time frame: 3 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 hyperlipidemia
Time frame: 3 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 HbA1c
Time frame: Baseline, 6 months, 12 months
The percent change in HbA1c laboratory results, at 6 and 12 months compared to baseline.
Change in LDL cholesterol
Time frame: Baseline, 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/ overweight
Time frame: Baseline, 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 C30
Time frame: Baseline, 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-23
Time frame: Baseline, 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.
9 secondary outcomes
Cardiovascular risk factors (tobacco use)
Time frame: 3 years
Cardiovascular risk factors (family history)
Time frame: 3 years
Cardiovascular risk factors (hypertension)
Time frame: 3 years
Referrals for individuals with pre-diabetes
Time frame: 3 years
Referrals for individuals with diabetes
Time frame: 3 years
Referrals for individuals with risk of cardiovascular disease
Time frame: 3 years
Prevalence of prediabetes in women with breast cancer versus healthy individuals
Time frame: 3 years
Prevalence of diabetes in women with breast cancer versus healthy individuals
Time frame: 3 years
Prevalence of hyperlipidemia in women with breast cancer versus healthy individuals
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruitingPhase 2
Tamoxifen Citrate or Z-Endoxifen Hydrochloride in Treating Patients With Locally Advanced or Metastatic, Estrogen Receptor-Positive, HER2-Negative Breast Cancer
Recurrent Breast Carcinoma, Stage III Breast Cancer AJCC v7
RecruitingPhase 1/2
A Study to Evaluate the Effect of GDC-4198 Alone and in Combination With Giredestrant Versus Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor-Negative (HER2-) Breast Cancer
Breast Cancer
Not yet recruiting
Podcast-Based Psychosocial Support for Women Newly Diagnosed With Breast Cancer
Breast Cancer
Recruiting
A Study of Skipping Radiation Therapy in People With Breast Cancer
HER2-positive Breast Cancer, Breast Cancer
Active, not recruiting
Dance Study for Post-surgical Pain in Breast Cancer Survivors
Breast Cancer, Survivorship
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer Sheng, M.D. principal investigator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prescreening, Screening and Enrollment and Baseline in people with Breast Cancer and Early-stage Breast Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hopkins Breast Trials (410-614-1361, HopkinsBreastTrials@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of prediabetes (time frame: 3 years). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.