Telematics Device for Daily Monitoring of Vital Signs in Cancer

The primary goal of this non-profit single-centre randomized pilot interventional study is to evaluate the acceptability of a daily telemonitoring of five vital parameters (heart rate, respiratory rate, blood oxygenation, blood pressure, and body temperature) using a medical device in advanced cancer patients with relevant cardiovascular and respiratory comorbidities assisted at home.In addition to the standard home care, participants in the intervention group will keep the medical device at home. They will register five vital parameters (heart rate, respiratory rate, blood oxygenation, blood pressure, and body temperature) once a day for eight weeks. Participants belonging to the control group will receive standard home care.The secondary goals of this study include the following:Analyzing the effect of telemonitoring on patients' quality of life and psychological status.Observing the possible effects of telemonitoring on the caregiver care burden.Assessing the possible effects of telemonitoring on the caregiver perceived satisfaction with the home care received.Comparing the number of physician and nurse home visits and phone calls between the patients using the device and patients in standard home care.Comparing the number of emergency room visits, admissions, and hospitalization days between the patients using the device and patients in standard home care.

INCLUSION CRITERIAPatients with advanced cancer assisted at home;Age ≥ 18 years;Able to understand the objectives of the study and sign the informed consent;Able to speak and understand the Italian language;KPS ≥ 50;Presence of at least one of the following comorbidities:Chronic Obstructive Pulmonary Disease (COPD);Chronic ischaemic heart disease (CIC) after acute myocardial infarction (AMI)Pulmonary emphysema;Valvulopathy;Systemic arterial hypertension;Severe coronary artery disease;Respiratory failure related to primary or metastatic lung cancer disease;Cardiomyopathy developed after oncological treatment. This symptomatology may be directly related to the oncological disease or independent of it (pre-existing pathology at the time of cancer diagnosis, symptoms occurring as a result of oncological therapies, age-related onset).The severity of these comorbidities must be relevant to the patient's clinical profile expressed in at least one of the following conditions:Resting oxygen saturation level < 90% in room air or oxygen therapy.Systolic/diastolic blood pressure greater than 140/90 mmHg or less than 90/60 mmHg, or on antihypertensive medication.Resting heart rate greater than 100 or less than 60 beats per minute or being treated with anti-arrhythmic drugs, presence of a pacemaker.EXCLUSION CRITERIAPatients with a diagnosis of dementia or cognitive impairment hampering the comprehension of the study information and/or signing of informed consent,Patients who are dying.Patients refusing to participate.