NCT06254196

Clinical Trial of Telenursing for Monitoring Supportive Care Needs in Patients With Lung Cancer and Melanoma Candidates for the First Prescription of Targeted Therapies

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Regina Elena Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Single-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 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 intervention.

Detailed description

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 telemedicine and have started teleassistance projects in various fields, especially in the nursing field. The study: 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. In particular: Patients enrolled in arm 1 will follow clinical practice with in presence visits and paper based questionnaire and tools, filled daily and periodically (1, 3, 6 months) Patients in arm 2 will use the Intelligence2health platform for telenursing interventions. For data collection, questionnaires on Google Forms will be used for the acquisition and control of data entered daily and periodically (1, 3, 6 months) by patients. A dedicated company telephone line for short communications will also be available to patients. Through a greater nursing intervention, this clinical trial will assess the impact of a telenursing intervention on monitoring and improving the supportive care needs and the treatment experience of candidate patients to the first prescription of Targeted Therapies for lung cancer and melanoma. The main objective is set to evaluate the effectiveness of a Telenursing 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 after 6 months), 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, 4 and 5 according to the Common, Terminology Criteria for Adverse Event, CTCAE). The study will also explore the differences between the Adverse Events reported by healthcare personnel and those reported by patients (Patient Reported Outcomes, PROs), trying to develop a specific one nursing reporting system for the remote management of Adverse Events oncology.

Conditions

• Lung Neoplasm
• Melanoma

Interventions

Type	Name	Description
PROCEDURE	Telenursing interventions for monitoring Supportive Care Needs	Use of the Intelligence2health platform, data collection forms on Google Forms, and dedicated telephone line for telenursing remote nursing monitoring interventions. Based on the data, nurses will be able to implement patient education interventions aimed at preventing and monitoring healthcare support needs related to treatment.

Timeline

• Start date: 2024-03-01
• Primary completion: 2025-03-01
• Completion: 2025-09-01
• First posted: 2024-02-12
• Last updated: 2024-06-03

Locations

1 site across 1 country: Italy