Lung CancerNCT04619810
"Impact of a Nursing Intervention in the Management of Oncological Patients With Lung Cancer Under Treatment With Immunotherapy"
A study testing Nurse intervention program in people with Lung Cancer, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 2 sites in Spain.
Trial summary
Introduction. Lung cancer is very common worldwide with 2.09 million cases in 2018. Immunotherapy has become a mainstay in cancer treatment. There is insuficient knowledge about the impact of altered needs, as well as the interventions developed by the nurse that are aimed at cancer patients in immunotherapy… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Nurse intervention program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 2 sitesSpain
- Study dates
- 20 Nov 2020to 25 Jan 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient of legal age (> or equal to 18 years), either male or female.
- Patient diagnosed with lung cancer regardless of subtype and / or stage. Except for small cell lung cancer, since this subtype of lung cancer is very different from the others and requires its own study.
- Patient receiving immunotherapy regardless of the treatment line.
- Patient who receives immunotherapy regardless of whether it is monotherapy or combination of chemotherapy.
- Patient who is able to consent to participate in the study.
- Patient who can read, understand and can communicate verbally.
Who cannot join
- Patient diagnosed with lung cancer synchronously with another neoplasm.
- Patients with speech disorders.
- Patients who do not understand or speak Spanish, Catalan or English.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Jorgina Serra López
Barcelona, 08041
About this study
Introduction. Lung cancer is very common worldwide with 2.09 million cases in 2018. Immunotherapy has become a mainstay in cancer treatment. There is insuficient knowledge about the impact of altered needs, as well as the interventions developed by the nurse that are aimed at cancer patients in immunotherapy treatment.
Objectives. Describe the needs of non-microcytic lung cancer patients in immunotherapy. And, evaluate the effectiveness of a nurse intervention program aimed at these patients in decreasing comorbidities, increasing satisfaction, early detection of symptoms and management of toxicities, quality of life and monitoring of anthropometric indicators.
Read more
Methodology. Phase 1: descriptive, cross-cutting and prospective study. Phase 2: quasi-experimental pre-post study. The sample is patients of the Hospital de la Santa Creu i Sant Pau, with non-microcytic lung cancer in treatment with Checkpoints inhibitor antibodies. The dependent variables: sociodemographic variables, clinical variables, satisfaction, quality of life, nutritional status, psychological impact, toxicities, number of unscheduled visits and health costs. Independent variable: nurse intervention program.
Implications for practice: Knowing the needs of patients in immunotherapy treatment will allow the development of a nurse care program to meet these needs and evaluate the program.
- Conditions
- Lung Cancer
- Being tested
- Nurse intervention program
- Keywords
- immunotherapy, lung cancer, nurse intervention program
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse intervention programOther
Implementation of a specific care program for patients receiving immunotherapy for lung cancer
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Other | quasi-experimental pre-post study Receives: Other: Nurse intervention program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of altered needs of patients with lung cancer undergoing treatment with immunotherapy
Detect the altered needs of patients with lung cancer in immunotherapy treatment. In order to outline the best intervention program that suits their needs. Through assessment through scales and questionnaires.
Measured: one day
Changes on anxiety in lung cancer patients with immunotherapy treatment measured by Hospital Anxiety and Depression Scale (HADS)
Assess the patient's level of anxiety from diagnosis and prior to initiating treatment up to 6 months after initiating treatment. Using the Hospital Anxiety and Depression Scale (HADS)
Measured: 6 months
Changes on quality of life in lung cancer patients with immunotherapy treatment measured by EORTC quality of life scale
Assess the quality of life of lung cancer patients from before starting immunotherapy up to 6 months after starting it. Through the EORTC QLQ-LC 30.
Measured: 6 months
Number of immunomediated toxicities requiring hospital admission
Record the number and type of toxicities that require hospital admission for its management.
Measured: 6 months
Secondary outcomes (1)
Number of nutritional alterations in patients with lung cancer, who start immunotherapy treatment
Through the Nutriscore scale and to records of specific values of the blood analysis of the nutritional status of patients with lung cancer before starting immunotherapy and 6 months after starting it.
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 posted6 Nov 2020
- Study start20 Nov 2020
- Primary completion10 Oct 2023
- Study completion25 Jan 2024
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 CancerStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04619810
- Sponsor's protocol ID
- IIBSP-IIE-2020-77
- Status last verified
- Jun 2024
- First submitted
- 21 Sep 2020
- Last updated
- 23 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Serra-Lopez J, Pujol-Besora C, Martinez-Recio S, Barba A, Riudavets Melia M, Sullivan I, Torralbas-Ortega J, Llado-Jordan G, Majem M, Martinez-Momblan MA. Clinical and economic impact of the advanced practice nurse in lung cancer patients receiving immunotherapy-based treatments: A quantitative study. Eur J Oncol Nurs. 2025 Feb;74:102809. doi: 10.1016/j.ejon.2025.102809. Epub 2025 Jan 23.
PubMed 39892201
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Impact of a Nursing Intervention in the Management of Oncological Patients With Lung Cancer Under Treatment With Immunotherapy"
- ClinicalTrials.gov ID
- NCT04619810
- Acronym / sponsor ID
- IIBSP-IIE-2020-77
- Conditions
- Lung Cancer
- Keywords
- immunotherapy, lung cancer, nurse intervention program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 10 Oct 2023 (actual)
- Study completion
- 25 Jan 2024 (actual)
- First posted
- 6 Nov 2020 (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.
Introduction. Lung cancer is very common worldwide with 2.09 million cases in 2018. Immunotherapy has become a mainstay in cancer treatment. There is insuficient knowledge about the impact of altered needs, as well as the interventions developed by the nurse that are aimed at cancer patients in immunotherapy treatment.
Objectives. Describe the needs of non-microcytic lung cancer patients in immunotherapy. And, evaluate the effectiveness of a nurse intervention program aimed at these patients in decreasing comorbidities, increasing satisfaction, early detection of symptoms and management of toxicities, quality of life and monitoring of anthropometric indicators.
Methodology. Phase 1: descriptive, cross-cutting and prospective study. Phase 2: quasi-experimental pre-post study. The sample is patients of the Hospital de la Santa Creu i Sant Pau, with non-microcytic lung cancer in treatment with Checkpoints inhibitor antibodies. The dependent variables: sociodemographic variables, clinical variables, satisfaction, quality of life, nutritional status, psychological impact, toxicities, number of unscheduled visits and health costs. Independent variable: nurse intervention program.
Implications for practice: Knowing the needs of patients in immunotherapy treatment will allow the development of a nurse care program to meet these needs and evaluate the program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Other | Other: Nurse intervention programquasi-experimental pre-post study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient of legal age (> or equal to 18 years), either male or female.
- Patient diagnosed with lung cancer regardless of subtype and / or stage. Except for small cell lung cancer, since this subtype of lung cancer is very different from the others and requires its own study.
- Patient receiving immunotherapy regardless of the treatment line.
- Patient who receives immunotherapy regardless of whether it is monotherapy or combination of chemotherapy.
- Patient who is able to consent to participate in the study.
Key exclusion criteria (3 listed)
- Patient diagnosed with lung cancer synchronously with another neoplasm.
- Patients with speech disorders.
- Patients who do not understand or speak Spanish, Catalan or English.
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 |
|---|---|---|
| Nurse intervention programImplementation of a specific care program for patients receiving immunotherapy for lung cancer | Other | Intervention arm |
Primary outcome
Number of altered needs of patients with lung cancer undergoing treatment with immunotherapy
Time frame: one day
Detect the altered needs of patients with lung cancer in immunotherapy treatment. In order to outline the best intervention program that suits their needs. Through assessment through scales and questionnaires.
Changes on anxiety in lung cancer patients with immunotherapy treatment measured by Hospital Anxiety and Depression Scale (HADS)
Time frame: 6 months
Assess the patient's level of anxiety from diagnosis and prior to initiating treatment up to 6 months after initiating treatment. Using the Hospital Anxiety and Depression Scale (HADS)
Changes on quality of life in lung cancer patients with immunotherapy treatment measured by EORTC quality of life scale
Time frame: 6 months
Assess the quality of life of lung cancer patients from before starting immunotherapy up to 6 months after starting it. Through the EORTC QLQ-LC 30.
Number of immunomediated toxicities requiring hospital admission
Time frame: 6 months
Record the number and type of toxicities that require hospital admission for its management.
1 secondary outcome
Number of nutritional alterations in patients with lung cancer, who start immunotherapy treatment
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Derived from this study: PubMed 39892201Serra-Lopez J, Pujol-Besora C, Martinez-Recio S, Barba A, Riudavets Melia M, Sullivan I, Torralbas-Ortega J, Llado-Jordan G, Majem M, Martinez-Momblan MA. Clinical and economic impact of the advanced practice nurse in lung cancer patients receiving immunotherapy-based treatments: A quantitative study. Eur J Oncol Nurs. 2025 Feb;74:102809. doi: 10.1016/j.ejon.2025.102809. Epub 2025 Jan 23.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse intervention program in people with Lung Cancer, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 2 sites in Spain.
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 6 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: finished, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of altered needs of patients with lung cancer undergoing treatment with immunotherapy (time frame: one day). The study lists 4 primary outcomes in all. 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 NCT04619810, 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 23 Jul 2024.