Lung NeoplasmTelenursingNCT06254196
Clinical Trial of Telenursing for Monitoring Supportive Care Needs in Patients With Lung Cancer and Melanoma Candidates for the First Prescription of Targeted Therapies
A study testing Telenursing interventions for monitoring Supportive Care Needs in people with Lung Neoplasm and Melanoma, run by Regina Elena Cancer Institute at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Neoplasm, Melanoma
- What is being tested?
- Telenursing interventions for monitoring Supportive Care Needs
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2024to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
"Regina Elena" National Cancer Institute
Rome, 00144
Aurora De Leo, Nursing, 0652662928, aurora.deleo@ifo.it
About this study
Official title: 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
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.
Read the 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
- Being tested
- Telenursing interventions for monitoring Supportive Care Needs
- Medical subject headings
- Lung Neoplasms, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telenursing interventions for monitoring Supportive Care NeedsProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group: current clinical practice | No intervention | Not described |
| Experimental group: Telenursing intervention | Experimental | Not described Receives: Procedure: Telenursing interventions for monitoring Supportive Care Needs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 month
Secondary outcomes (2)
Need for supportive care
Assess the need for supportive care over time from the start of the trial to the end of the study.
Measured: 6 months
Evaluate the incidence and severity of Adverse Events.
Evaluate the incidence and degree of severity of all Adverse Events in grades 1, 2, 3 and 4 according to the Common, Terminology Criteria for Adverse Event, CTCAE.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start1 Mar 2024
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regina Elena Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aurora De Leo, Nursing, Principal investigator, IRCCS "Regina Elena" National Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06254196
- Sponsor's protocol ID
- RS1851/23
- Acronym
- Telenursing
- Status last verified
- May 2024
- First submitted
- 11 Dec 2023
- Last updated
- 3 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39452792
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06254196
- Acronym / sponsor ID
- Telenursing / RS1851/23
- Conditions
- Lung Neoplasm, Melanoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Regina Elena Cancer InstituteUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 12 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group: current clinical practice | No intervention | – |
| Experimental group: Telenursing intervention | Experimental | Procedure: Telenursing interventions for monitoring Supportive Care Needs |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telenursing interventions for monitoring Supportive Care NeedsUse 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. | Procedure or surgery | Experimental group: Telenursing intervention |
Primary outcome
Evaluate the effectiveness of the nursing intervention.
Time frame: 6 month
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).
2 secondary outcomes
Need for supportive care
Time frame: 6 months
Evaluate the incidence and severity of Adverse Events.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
- Derived from this study: PubMed 39452792De 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aurora De Leo, Nursing principal investigator
IRCCS "Regina Elena" National Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telenursing interventions for monitoring Supportive Care Needs in people with Lung Neoplasm and Melanoma, run by Regina Elena Cancer Institute at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aurora De Leo, Nursing (0652662928, aurora.deleo@ifo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the effectiveness of the nursing intervention. (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06254196, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2024.