Cardiac Aggressive Risk Mitigation in Thoracic Radiotherapy (CARMA) Trial (CARMA)

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

The purpose of this study is to examine adherence to cardio-oncology consultation.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Other: Cardiac Aggressive Risk MitigAtion Plan

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cancer Clinical Trials Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: CARMA; Cardiac Aggressive Risk MitigAtion plan with biosensor monitoring

Other: Cardiac Aggressive Risk MitigAtion Plan; 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.; Other Names: FitBit; Omron EVOLV Automatic Blood Pressure Monitor; AliveCor KardiaMobile Personal EKG Monitor; cardio-oncology consultation

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Investigators: Principal Investigator: Katelyn Atkins, MD, PhD, Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2022
• Primary Completion (Actual): June 16, 2023
• Study Completion (Actual): June 16, 2023

Study Registration Dates

• First Submitted: March 11, 2022
• First Submitted That Met QC Criteria: May 31, 2022
• First Posted (Actual): June 3, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 4, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: breast cancer; lung cancer; esophageal cancer; radiation therapy; cardiology; cardiac toxicity; cardio-oncology; thoracic radiotherapy
• Additional Relevant MeSH Terms: Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Aggression
• Other Study ID Numbers: IIT2021-07-Atkins-CARMA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No