Telematics Device for Daily Monitoring of Vital Signs in Cancer

Launched by FONDAZIONE ANT ITALIA ONLUS · Dec 12, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at how well a special device can help monitor important health signs in patients with advanced cancer who also have heart or lung issues. The study aims to see if using this telemonitoring device, which records daily information like heart rate, breathing rate, blood oxygen levels, blood pressure, and body temperature, is acceptable for patients receiving home care. Participants will be divided into two groups: one group will use the device and continue with their regular home care, while the other group will only receive standard home care. The study will also look at how this monitoring affects the patients' quality of life, their caregivers' stress levels, and the need for medical visits or hospital stays.

To be eligible for this study, participants must be at least 18 years old, have advanced cancer, and be able to understand the study's purpose and sign consent. They should also speak Italian and have certain health issues related to their condition, like chronic lung disease or heart problems. If you or a loved one is interested in this study, it’s important to know that it does not include patients with severe cognitive issues or those who are nearing the end of life. Overall, the trial could provide valuable insights into how telemonitoring can enhance care for patients with complex health needs.

Gender

ALL

Eligibility criteria

• • INCLUSION CRITERIA
• • Patients 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 CRITERIA
• • Patients 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.

Trial Officials