IIT2021-07-Atkins-CARMA: Cardiac Aggressive Risk Mitigation in Thoracic Radiotherapy (CARMA) Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Number of participants who complete the cardio-oncology consultation visit
研究概览
简要总结
The purpose of this study is to examine adherence to cardio-oncology consultation.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
- •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.
排除标准
- •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.
结局指标
主要结局
Number of participants who complete the cardio-oncology consultation visit
时间窗: From baseline to 3 months
Adherence is defined as 70% of the participants completing the cardio-oncology consultation visit prior to or during radiotherapy.
次要结局
- 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(From baseline to 3 months)
- Number of participants who obtain electrocardiogram (EKG) readings for at least 4 timepoints(From baseline to 3 months)
- Number of participants who obtain blood pressure readings for at least 4 timepoints(From baseline to 3 months)
- Rate of compliance with cardiovascular therapeutic medication intervention(From baseline to 3 months)
- Evaluate participant intervention perspectives at the end of the study.(At 3 months)
- Rate of cardiovascular therapeutic medication intervention recommendations by the cardio-oncologist(From baseline to 3 months)
研究者
Katelyn Atkins
Assistant Professor, Radiation Oncology
Cedars-Sinai Medical Center