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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
20
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.
Cancer Clinical Trials Office
Los Angeles, California, United States
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.
Time frame: From baseline to 3 months
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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: From baseline to 3 months
Rate of compliance with cardiovascular therapeutic medication intervention
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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.
Time frame: 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.
Time frame: At 3 months