Melanoma Clinical Trial
Official title:
Randomized Clinical Trial of Telenursing for Monitoring Supportive Care Needs in Patients With Lung Cancer and Melanoma Candidates for the First Prescription of Targeted Therapies
ingle-center, randomized clinical trial (RCT) with low intervention level (Telenursing), for the monitoring of patients affected by lung cancer and melanoma who are candidates for first prescription with Targeted Therapies. The study population will consist of patients suffering from lung cancer and melanoma. The objective of the study will be to evaluate the effectiveness of a Telenursing nursing intervention, comparing the mean score of the total SCNs scale (Supportive Care Needs) after one month of treatment in the treatment arm and in the control arm. Enrolled patients will then be randomized into two treatment arms: - Arm 1 (Control Group): current clinical practice - Arm 2 (Experimental group): Telenursing nursing intervention.
To cope with the welfare limits imposed from the SARS-CoV2 pandemic, the specialists of the I.R.C.C.S. Hospital Physiotherapy Institutes (IFO) of Rome have increased the use of the DNMlab ® digital platform created by DNM SRL and have started teleassistance projects in various fields, especially in the nursing field. The new platform is currently being purchased from the same institutes "InovaMED" created by IKINOVA SRL, who responds with the aim of improving continuity of care, taking charge and monitoring of patients, information flow, interaction, communication and relationship with the team cure and is therefore an ideal tool in the management of cancer patients in home treatment. The patient will have the opportunity to log in to their account and view their dashboard personal (interface) which contains all your medical information, the healthcare worker will be able to access the platform with their own credentials and view the list of patients assigned to him and the related clinical and operational data. Through the use of the InovaMED platform, this clinical trial is proposed the objective of monitoring the assistance needs and the treatment experience of candidate patients to the first prescription of Targeted Therapies for lung cancer and melanoma, in relationship to perceived health status and satisfaction with the care received, to improve it management and the therapeutic path. In case of impossibility to purchase the platform by the Institution, this study will use the Telemedicine platform currently used within the same institutes. Therefore it is a single-centre, randomized clinical trial (RCT) with a low level of intervention (Telenursing), for the monitoring of patients affected by lung cancer and melanoma who are candidates for first prescription with Targeted Therapies. The main objective is set to evaluate the effectiveness of a Telenursing nursing intervention, choosing to compare the mean score of the total SCNs scale (Supportive Care Needs) after one month of treatment in the treatment arm and in the control arm. Furthermore, among the secondary objectives we will evaluate Supportive Care Needs over time (until the end of the study), the quality of life, the degree of patient satisfaction, the therapeutic adherence and finally the incidence and degree of severity of all Adverse Events (grade 1, 2, 3 and 4 according to the Common, Terminology Criteria for Adverse Event, CTCAE). Also explore the differences between the Adverse Events reported by healthcare personnel and those reported by patients (Patient Reported Outcomes, PROs) and develop a specific one nursing reporting system for the remote management of Adverse Events oncology. ;
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