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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06254196
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Regina Elena Cancer Institute
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Aurora De Leo, Nursing
Principal Investigator Affiliation	IRCCS "Regina Elena" National Cancer Institute
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Italy
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Lung Neoplasm, Melanoma

Additional Details

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.

Arms & Interventions

Arms

No Intervention: Control group: current clinical practice

Experimental: Experimental group: Telenursing intervention

Interventions

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.

Contact a Trial Team

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International Sites

"Regina Elena" National Cancer Institute, Rome, Italy

Status

Recruiting

Address

"Regina Elena" National Cancer Institute

Rome, , 00144

Site Contact

Aurora De Leo, Nursing

[email protected]

0652662928

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