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.

Study Overview

• Status: Recruiting
• Conditions: Melanoma; Lung Neoplasm
• Intervention / Treatment: Other: Telenursing interventions for monitoring Supportive Care Needs

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 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.

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aurora De Leo, Nursing; Phone Number: 0652662928; Email: aurora.deleo@ifo.it

Study Locations

• Italy
  • Rome, Italy, 00144
    • Recruiting
    • "Regina Elena" National Cancer Institute
    • Contact: Aurora De Leo, Nursing; Phone Number: 0652662928; Email: aurora.deleo@ifo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• aged between 18 and 75;
• patients suffering from lung cancer and melanoma candidates for the first prescription with Targeted Therapies in exclusive treatment;
• patients able to understand, speak Italian and join the study by signing of paper informed consent;
• possibility of accessing and using the information technologies adopted in trial through a PC/tablet and personal internet connection;
• patients willing to comply with study procedures.

Exclusion Criteria:

• patients not suffering from lung cancer or melanoma;
• patients already treated or currently being treated with Targeted Therapies, or other treatment (chemotherapy and/or radiotherapy and/or exclusive palliative care);
• patients with cognitive problems, psychiatric disorders and poor compliance who could interfere with study participation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group: current clinical practice
Experimental: Experimental group: Telenursing nursing intervention	Other: Telenursing interventions for monitoring Supportive Care Needs; Telenursing interventions will use the InovaMed platform for acquisition and control of the data entered daily by patients and will be able to implement interventions patient education in person and remotely, aimed at the prevention and monitoring of Supportive Care Needs related to treatment. In the first month, a nurse involved in the study will carry out two Telenursing interventions through a video call, subsequent interventions will be carried out on a monthly basis, on dates previously agreed with the interested parties, fifteen days after the visit presence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Telenursing nursing intervention	Effectiveness of a Telenursing nursing intervention we have chosen compare the average score after one month of treatment of the total SCN scale (Need for supportive care) in the treatment arm and control arm by administering a form for monitoring support therapy needs (Ebrahimabadi et al., 2021; Zeneli et al., 2016)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure of quality of life	Assess quality of life through administration of the SF-36 QoL sheet (Apolone & Mosconi, 1998; Ware & Sherbourne, 1992)	12 months
Patient satisfaction	The degree of patient satisfaction by administering the form relating to satisfaction and usability of the SUS system - System Usability Scale (Borsci et al., 2009; Brooke, 1996)	12 months
Supportive Care Needs	Therapeutic adherence and 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) by administering a form for monitoring Supportive Care Needs (Ebrahimabadi et al., 2021; Zeneli et al., 2016) sheet for measuring adverse events: Likert scale 1-5 - filled in by clinicians and by research nurses during the monthly in-person visit (CTCAE)	12 months
Patient Reported Outcomes, PROs	Explore the differences between the Adverse Events reported by healthcare personnel and those reported by patients (Patient Reported Outcomes, PROs)	12 months

Collaborators and Investigators

• Sponsor: Regina Elena Cancer Institute
• Investigators: Principal Investigator: Aurora De Leo, Nursing, IRCCS "Regina Elena" National Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: December 11, 2023
• First Submitted That Met QC Criteria: February 2, 2024
• First Posted (Actual): February 12, 2024

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Lung Neoplasms; Melanoma
• Other Study ID Numbers: RS1851/23

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No