None listed
Conditions
Brief summary
The purpose of this study is to improve survivorship of cancer patients in relation with cardiovascular condition. Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with cancer and have cardiovascular risks. Study details Participants will be randomised 1:1 to either intervention or usual care(control group). All participants will also be asked to complete an interview and assessments at baseline and be followed up for 12 months and optional 24 months which includes vital signs, blood tests, ECG, echocardiongram,and questonnaires. If the test results are available, we'll collect data through medical records, however it these are not available, participants are asked to do the tests. Intervention group will be seen by cardio-oncology team at least 3 monthly with additional care. It is hoped that this study will help improve survivorship in patient with cancer while minimising interruption of cancer therapy and cardiovascular risks and managing cardiotoxicity.
Interventions
Patients referred to the cardio-oncology service will be randomised (1:1) to specialised cardio-oncology clinic assessment and regular follow-up within the cardio-oncology clinic service at least 3 monthly as clinically needed. Patients will be assessed at 12-months following enrolment. There will be an option for 24-month follow-up. In addition, there will be visits 3- and 12-months following completion of cancer therapy for intervention group.
The duration of the visit would be between 20 m
Patients referred to the cardio-oncology service will be randomised (1:1) to specialised cardio-oncology clinic assessment and regular follow-up within the cardio-oncology clinic service at least 3 monthly as clinically needed. Patients will be assessed at 12-months following enrolment. There will be an option for 24-month follow-up. In addition, there will be visits 3- and 12-months following completion of cancer therapy for intervention group. The duration of the visit would be between 20 minutes and 60 minutes depending on clinical indication and assessment required. Intervention group will receive full consultation and follow-up management from the cardiologist and be prescribed medications if clinically indicated. The frequency of follow-up will vary depending on clinical indication. Strategies used to assess adherence to the intervention will be review of medical records and interview during the consultation. Patients' involvement is needed for study visits, consultation, tests such as blood tests, ECG, echocardiogram and questionnaires. If the results are available within the last month, patients don't need to repeat the tests. Patients health information such as medical history, disease status and treatment will be obtained via medical record. Linked data for emergency, hospitalisation, and cause of death will be obtained from The Centre for Health Record Linkage (CHeReL).
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Primary purpose
Prevention
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults greater than or equal to 18 years initiating cancer therapy for a solid cancer of one of the following types - primary cancer of prostate, bladder, testicular, lung, breast, or colorectal and either 2. At high cardiovascular risk – a) pre-existing cardiovascular disease, OR b) high cardiovascular risk as estimated by the 2023 Australian cardiovascular risk calculator (https://www.cvdcheck.org.au/calculator); OR 3. Cancer treatment-related cardiotoxicity- a) Cancer-therapy related cardiac dysfunction (CTRCD), b) Vascular c) Hypertension, d) Arrhythmias , e) ICI (Immune Checkpoint Inhibitor) myocarditis
Exclusion criteria
1. Unwillingness to participate within the study (i.e. not consented)
Outcome results
None listed