Cancer
Conditions
Keywords
radiation therapy, cardio-oncology, cardiology, cardiac toxicity, lung cancer, esophageal cancer, breast cancer, thoracic radiotherapy
Brief summary
The purpose of this study is to examine adherence to cardio-oncology consultation.
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.
Interventions
OTHERCardiac 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.
Sponsors
Cedars-Sinai Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Open Label
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who complete the cardio-oncology consultation visit | From baseline to 3 months | Adherence is defined as 70% of the participants completing the cardio-oncology consultation visit prior to or during radiotherapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who obtain blood pressure readings for at least 4 timepoints | From baseline to 3 months | 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. |
| Number of participants who obtain electrocardiogram (EKG) readings for at least 4 timepoints | From baseline to 3 months | Proportion of participants who obtain EKG readings for at least 4 timepoints. -The AliveCor KardiaMobile EKG monitor will be used to obtain EKG readings |
| 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 | 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 |
| Rate of compliance with cardiovascular therapeutic medication intervention | From baseline to 3 months | 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. |
| Evaluate participant intervention perspectives at the end of the study. | At 3 months | * 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. |
| Rate of cardiovascular therapeutic medication intervention recommendations by the cardio-oncologist | From baseline to 3 months | 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. |
Countries
United States
Outcome results
None listed