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Behavioral Intervention

In-person cardiac rehabilitation for Cardiovascular Disease

N/A

Recruiting

Led By Husam Abdel-Qadir, MD-PhD

Research Sponsored by Women's College Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age greater than 50 years

Previous receipt of anthracyclines and/or trastuzumab for breast cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 weeks before starting cardiac rehabilitation, 1 week after completing cardiac rehabilitation, and 6 months after completing cardiac rehabilitation

Awards & highlights

Study Summary

This trial aims to understand if virtual or in-person cardiac rehabilitation can help reduce cardiovascular disease risk in breast cancer survivors treated with certain medications. 50 participants will be recruited and randomly assigned to either the virtual

Who is the study for?

This trial is for women over 50 who have been treated for breast cancer with anthracyclines and/or trastuzumab and are at risk of heart disease. They must be able to do in-person exercise and follow the study's rules. Those who can't safely exercise or won't stick to the protocols cannot join.Check my eligibility

What is being tested?

The study tests if cardiac rehab programs, either done in person or virtually, can lower heart disease risk in breast cancer survivors. Participants will be randomly placed into one of these two groups to compare effects on heart health, fitness, activity levels, and mental well-being.See study design

What are the potential side effects?

Since this trial involves physical rehabilitation exercises rather than medication, side effects may include typical exercise-related issues such as muscle soreness or fatigue. However, specific side effects will depend on individual health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 50 years old.

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I have been treated with anthracyclines or trastuzumab for breast cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 weeks before starting cardiac rehabilitation, 1 week after completing cardiac rehabilitation, and 6 months after completing cardiac rehabilitation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 weeks before starting cardiac rehabilitation, 1 week after completing cardiac rehabilitation, and 6 months after completing cardiac rehabilitation

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks before starting cardiac rehabilitation, 1 week after completing cardiac rehabilitation, and 6 months after completing cardiac rehabilitation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Intervention adherence

Intervention safety

Participant satisfaction

+3 more

Secondary outcome measures

Automated Self-Administered Dietary Assessment Tool (ASA24)

Beck Depression Inventory

Duke Activity Status Index

+8 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Virtual cardiac rehabilitationExperimental Treatment1 Intervention

Those randomized to the virtual, home-based rehabilitation group

Group II: In-person cardiac rehabilitationExperimental Treatment1 Intervention

Those randomized to in-person cardiac rehabilitation group

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Women's College HospitalLead Sponsor

101 Previous Clinical Trials

39,042 Total Patients Enrolled

Husam Abdel-Qadir, MD-PhDPrincipal InvestigatorWomen's College Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available positions for patients to participate in this clinical trial?

"The details on clinicaltrials.gov reveal that this research study is currently seeking participants. Originally listed on March 21st, 2023, the trial received its latest update on February 1st, 2024."

Answered by AI

What is the primary goal or purpose of this medical study?

"During a 1-week observation period following the intervention, the primary measure in this study is participant contentment. Secondary measures involve determining left ventricular ejection fraction (LVEF) through electrocardiography as per established guidelines, monitoring physical activity levels using Fitbits throughout cardiac rehabilitation participation, and assessing depression levels via self-reported Beck Depression Inventory evaluations."

Answered by AI

What is the current number of participants being recruited for this research study?

"Indeed, information retrieved from clinicaltrials.gov reveals that this medical investigation is presently seeking suitable participants. Initially uploaded on March 21st, 2023, and most recently revised on February 1st, 2024, the study aims to enroll a total of 50 patients across one designated location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cardiac Rehabilitation for Breast Cancer Survivors

Husam Abdel-Qadir 2023. "Cardiac Rehabilitation for Breast Cancer Survivors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06251401.