To hear about similar clinical trials, please enter your email below
Trial Title:
Clinical Trial of Telenursing for Monitoring Supportive Care Needs in Patients With Lung Cancer and Melanoma Candidates for the First Prescription of Targeted Therapies
NCT ID:
NCT06254196
Condition:
Lung Neoplasm
Melanoma
Conditions: Official terms:
Melanoma
Lung Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Procedure
Intervention name:
Telenursing interventions for monitoring Supportive Care Needs
Description:
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.
Arm group label:
Experimental group: Telenursing intervention
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.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
"Regina Elena" National Cancer Institute
Address:
City:
Rome
Zip:
00144
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Aurora De Leo, Nursing
Phone:
0652662928
Email:
aurora.deleo@ifo.it
Start date:
March 1, 2024
Completion date:
September 1, 2025
Lead sponsor:
Agency:
Regina Elena Cancer Institute
Agency class:
Other
Source:
Regina Elena Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06254196
