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The purpose of this study is to examine adherence to cardio-oncology consultation.
The purpose of this study is to evaluate patient participation in a plan to improve heart health after radiation therapy by having a cardio-oncology assessment early during cancer treatment. Cardiologists and cancer doctors will review any cardiovascular risk factors (heart conditions, hypertension, bleeding disorders, smoking history, obesity, cholesterol and diabetes) and develop a personalized treatment plan. In addition, the study will evaluate use of wearable devices such as a FitBit, and remote EKG (Omron EVOLV) and blood pressure monitoring (AliveCor KardiaMobile) devices to monitor participant's health. Blood will be drawn at three separate timepoints for biomarker testing of heart injury, aging, inflammation and metabolism.
Study visits will occur at baseline, weekly during radiation therapy, 6 weeks and 3 months after completion of radiation therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CARMA | Experimental | Cardiac Aggressive Risk MitigAtion plan with biosensor monitoring |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac Aggressive Risk MitigAtion Plan | Other | Cardio-oncology consultation along with long-term collaborative cancer care visits during standard of care radiation therapy that will occur weekly for up to 6 weeks followed by 6-week and 3-month follow-up visits. Health will be monitored with biosensor monitoring devices. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who complete the cardio-oncology consultation visit | Adherence is defined as 70% of the participants completing the cardio-oncology consultation visit prior to or during radiotherapy. | From baseline to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who wear the FitBit device at least 10 hours per day for 4 out of the 7 days prior to each study visit | Proportion of participants who wear the FitBit device at least 10 hours per day for 4 out of the 7 days prior to each study visit | From baseline to 3 months |
| Number of participants who obtain blood pressure readings for at least 4 timepoints |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katelyn Atkins, MD, PhD | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Clinical Trials Office | Los Angeles | California | 90048 | United States |
Individual deidentified participant data (including data dictionaries) supporting the manuscript findings will be shared beginning three months after publication and without end date with qualified investigators whose proposed use of the data has been approved by an institutional review board and following execution of a data use agreement per Cedars-Sinai Medical Center institutional policy. The study protocol will additionally be shared.
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D066126 | Cardiotoxicity |
| D008175 | Lung Neoplasms |
| D004938 | Esophageal Neoplasms |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Proportion of participants who obtain blood pressure readings for at least 4 timepoints. -The Omron blood pressure monitor will be used to obtain blood pressure readings. |
| From baseline to 3 months |
| Number of participants who obtain electrocardiogram (EKG) readings for at least 4 timepoints | Proportion of participants who obtain EKG readings for at least 4 timepoints. -The AliveCor KardiaMobile EKG monitor will be used to obtain EKG readings | From baseline to 3 months |
| Rate of cardiovascular therapeutic medication intervention recommendations by the cardio-oncologist | Number of participants provided recommendation to either initiate, or modify the dose of, a cardiovascular risk-reducing medication (anti-lipid, anti-platelet, anti-coagulation, anti-hypertensive). Expressed as the number of participants as a fraction of the total number of participants. | From baseline to 3 months |
| Rate of compliance with cardiovascular therapeutic medication intervention | Compliance will be assessed by self-reporting of medication usage at the 3-month follow-up and defined as yes or no for all recommended cardiovascular therapeutic medication interventions. Expressed as the number of participants as a fraction of the total number of participants. | From baseline to 3 months |
| Evaluate participant intervention perspectives at the end of the study. |
| At 3 months |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |