Cardiac Aggressive Risk Mitigation in Thoracic Radiotherapy (CARMA) Trial

Study Overview
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Brief Summary
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The purpose of this study is to examine adherence to cardio-oncology consultation.

Detailed Description
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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.

Official Title
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IIT2021-07-Atkins-CARMA: Cardiac Aggressive Risk Mitigation in Thoracic Radiotherapy (CARMA) Trial

Conditions
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Cancer

Intervention / Treatment
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* Other: Cardiac Aggressive Risk MitigAtion Plan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any stage (I-IV) malignancy being treated with high dose (≥30 Gy) radiotherapy where the heart is in the treatment field. Have Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2. Planning to receive standard of care radiotherapy treatments. Access to a smart device that has the capability to sync to the devices. Written informed consent obtained from subject and ability for subject to comply with the requirements of the study. Ability to read, write and understand English. Exclusion Criteria: Known allergy to surgical steel or elastomer/rubber. Heart attack within 6 months prior to study enrollment. Severe and/or active scleroderma or systemic lupus erythematosus.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Open Label
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CARMA<br>Cardiac Aggressive Risk MitigAtion plan with biosensor monitoring | Other: Cardiac Aggressive Risk MitigAtion Plan<br>* 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.<br>* Other names: cardio-oncology consultation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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. | Analyze participate attitudes and perspectives on implementation and impact of the cardiovascular intervention plan. Participants will be asked to complete a survey at the 3-month visit. Each question is either answered on a scale of 1-4 or strongly agree-strongly disagree, where higher scores indicate the highest level of burden or disagreement, respectively. | At 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radiation therapy, cardio-oncology, cardiology, cardiac toxicity, lung cancer, esophageal cancer, breast cancer, thoracic radiotherapy