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

NCT06254196 | Recruiting

• 1 other identifier: RS1851/23
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Neoplasm; Melanoma

Outcome Measures

Primary Outcomes (1)

• Evaluate the effectiveness of the nursing intervention.

  Evaluate the effectiveness of the Telenursing nursing intervention by comparing the average score after one month of treatment on the total SCN (Supportive Care Needs) scale in the treatment arm and in the control arm, using the Supportive Care Needs monitoring form, to the measurement of adverse events using the 1-5 Likert scale - filled in by clinicians and by research nurses during the monthly in-person visit, according to the Common Terminology Criteria for Adverse Events (CTCAE).

  6 month

Secondary Outcomes (2)

• Need for supportive care

  6 months

• Evaluate the incidence and severity of Adverse Events.

  6 months

Study Arms (2)

Control group: current clinical practice

NO INTERVENTION

Experimental group: Telenursing intervention

EXPERIMENTAL

Procedure: Telenursing interventions for monitoring Supportive Care Needs

Interventions

Telenursing interventions for monitoring Supportive Care Needs PROCEDURE

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.

Experimental group: Telenursing intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Regina Elena Cancer Institute: lead

Study Sites (1)

"Regina Elena" National Cancer Institute

Rome, 00144, Italy

RECRUITING

Related Publications (1)

• De Leo A, Liquori G, Spano A, Panattoni N, Dionisi S, Iacorossi L, Giannetta N, Terrenato I, Di Simone E, Di Muzio M, Petrone F. Effect of Telenursing on Supportive Care Needs in Patients with Melanoma and Lung Cancer on Targeted Therapies: A Randomised Controlled Trial Study Protocol. Methods Protoc. 2024 Oct 3;7(5):78. doi: 10.3390/mps7050078.

  PMID: 39452792 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Melanoma

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Aurora De Leo, Nursing

  IRCCS "Regina Elena" National Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aurora De Leo, Nursing

CONTACT

0652662928; aurora.deleo@ifo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: February 12, 2024
• Study Start: March 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: September 1, 2025
• Last Updated: June 3, 2024

Record last verified: 2024-05

Locations

IT (1)