None listed
Conditions
Brief summary
The purpose of this study is to assess the outcomes of early intervention from cardio-oncology service for testicular cancer patients with heart risks and compare this data to testicular cancer patients who receive cares from their oncologist. Who is it for? You may be eligible for this study if you are an man with a diagnosis of testicular cancer within the last 5 years that either: 1. is receiving cisplatin-based chemotherapy; or 2. is planned to receive cisplatin-based chemotherapy within 1 month of enrolment; or 3. completed treatment of testicular cancer with cisplatin-based chemotherapy Study details All participants will also be asked to complete an interview at baseline and be followed up for 3 months(phone call), 6 months, 12 months, and optional 18 months (phone call) and optional 24 months which includes vital signs, blood tests, echocardiongram,and questonnaires. Intervention group will receive text message for education and support and may be prescribed medication for LDL and blood pressure if clinically indicated. Intervention group may see the cardiologist based on an as-needed basis as determined by the cardiologist. The control arm will be initially assessed within the cardio-oncology service and then a letter will be provided to their treating physician detailing ongoing care and receive usual clinical care, according to the treating physician’s standard practice. It is hoped that this study help mitigate longterm cardiovascular morbidity and improve qulaity of life in poeple diagnosed with testicular cancer.
Interventions
Patients need to attend clinic visits at baseline, 6 months, 12 months and optional 24 months, and phone call follow-up at 3 months and optional 18 months.
Intervention group will receive pharmacotherapy (Statin, Blood pressure lowering medication) if clinically indicated and the criteria for pharmacotherapy and agent and the dose of each drug will be decided by clinician's discretion. Also intervention group will receive text messages for education and support. Message content will cover: diet,
Patients need to attend clinic visits at baseline, 6 months, 12 months and optional 24 months, and phone call follow-up at 3 months and optional 18 months. Intervention group will receive pharmacotherapy (Statin, Blood pressure lowering medication) if clinically indicated and the criteria for pharmacotherapy and agent and the dose of each drug will be decided by clinician's discretion. Also intervention group will receive text messages for education and support. Message content will cover: diet, physical activity, smoking if applicable, medication adherence, and general cardiovascular health. The frequency and duration of text messages is twice weekly for 12 months. The approximate length of each text message is 2-3 sentences, The strategy used to monitor adherence to the text message is that in some of our messages, we provide links to health resources where we can monitor who has actively clicked a specific link. This is a way we can show patient's are participating with the content provided.
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Men with a diagnosis of testicular cancer within the last 5 years that either: 1. is receiving cisplatin-based chemotherapy; or 2. is planned to receive cisplatin-based chemotherapy within 1 month of enrolment; or 3. completed treatment of testicular cancer with cisplatin-based chemotherapy
Exclusion criteria
Patients will be excluded if they: 1. are unwilling to provide consent; or 2. are <18 years of age; or 3. see a cardiologist at least annually 4. have LDL-C <1.8mmol/L in secondary prevention/high-risk primary or <2.5mmol/L in primary prevention, and have a systolic blood pressure equal to or less than 120mmHg
Outcome results
None listed