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Non-Small Cell Lung CancerAIRPALNCT07039994

Early Palliative Care in Patients With Advanced Lung Cancer Using an e-Health Ecosystem

A study testing Standard intervention and E-health intervention in people with Non-Small Cell Lung Cancer, run by Jesús González at 2 sites in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Palliative care has long been associated primarily with end-of-life support. However, its scope is much broader. As highlighted in the Hastings Center Report, the purposes of medicine include not only curing disease but also preventing illness, relieving suffering, caring for patients, avoiding preventable deaths, and… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
Standard intervention and E-health intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
2 sitesSpain
Study dates
24 Dec 2024to 24 Jul 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients diagnosed with advanced NSCLC (stage III or IV) with criteria for early palliative intervention*, seen in the initial palliative care consultation.
  • Patients or primary caregivers with internet proficiency and access to computer and telephone equipment.
  • Patients with ECOG performance status 0-3
  • For the purposes of this study, patients with the following conditions will be considered candidates for early palliative care: a tumor diagnosis ≤3 months prior to diagnosis and one or more of the following criteria: average pain poorly controlled with opioids (VAS score ≥4); dyspnea on minor exertion; patients <60 years of age; emotional distress (HADS ≥10); family fragility; functional limitation (Barthel <60); history or use of drugs; and the presence of ethical or existential dilemmas (Llorens et al., 2017; Tuca et al., 2019).

Who cannot join

  • Patients who do not meet criteria for early palliative intervention.
  • Patients with severe cognitive impairment or psychiatric impairment that prevents proper evaluation.
  • Patients who do not speak or understand Catalan or Spanish adequately.
  • Patients who, at the first visit, are in a serious clinical condition that prevents proper evaluation.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jesús González Barboteo, MD, PhD contact

932607733 ext. +34

jgonzalez@iconcologia.net

Miguel Mateu Sanz, PhD contact

932607733 ext. +34

mmateu@iconcologia.net

Spain2 sites, 2 recruiting
  • Catalan Institute of Oncology

    Badalona, Barcelona, 08916

    Agnès Calsina Berna, MD, PhD, 934978800 ext. +34, acalsina@iconcologia.net

    Not yet recruiting
  • Catalan Institute of Oncology

    L'Hospitalet de Llobregat, Barcelona, 08908

    Jesús González Barboteo, MD, PhD, 932607733 ext. +34, jgonzalez@iconcologia.net

    Recruiting

Other trials in Spain

About this study

Official title: Early Palliative Care in Patients With Advanced Lung Cancer Using an e-Health Ecosystem: a Randomized, Controlled, and Blinded Clinical Trial

Palliative care has long been associated primarily with end-of-life support. However, its scope is much broader. As highlighted in the Hastings Center Report, the purposes of medicine include not only curing disease but also preventing illness, relieving suffering, caring for patients, avoiding preventable deaths, and ensuring a peaceful death when unavoidable. Palliative care plays a vital role in achieving all of these goals. In addition to pain and symptom management, it addresses the prevention of complicated grief, the emergence of severe symptoms (e.g., constipation, delirium), the inappropriate use of end-of-life treatments, and offers specialized care for incurable diseases.

This model of care follows a multidimensional and multidisciplinary approach, focusing on the person beyond the illness and addressing emotional, social, spiritual, and practical needs. Recent studies have shown that early integration of palliative care within routine oncology improves symptom control, emotional well-being, and coping with the illness. Furthermore, it enhances quality of life for both patients and their families, reduces healthcare resource usage, and does not increase overall health expenditure.

Read more

Such early integration also facilitates discussions about end-of-life issues, promotes advance care planning, and supports improved home-based palliative care. Additionally, it has been associated with fewer aggressive treatments and a positive impact on patient survival.

Systematic symptom assessment leads to earlier and more effective management. In this context, information and communication technologies (ICTs) have shown promise in enabling remote monitoring and care delivery. These tools can enhance quality of life, improve treatment adherence, reduce emergency visits, and positively influence survival. However, existing studies have limitations, such as small sample sizes and lack of evaluator blinding.

The COVID-19 pandemic emphasized the need for physical distancing and accelerated the development of remote healthcare systems. Some specialized cancer centers, like the Institut Català d'Oncologia, have implemented functional multidisciplinary units for each cancer type. These units consist of various specialists (medical oncologists, radiation oncologists, surgeons, radiologists, pathologists, advanced practice nurses, palliative care professionals, etc.) who collaboratively decide the best course of treatment. A key role within these units is the reference nurse, assigned to each patient, who acts as a main point of contact, available for in-person or phone consultations.

One major improvement in recent years has been the integration of palliative care clinics within oncology departments. Best practices now emphasize early palliative intervention based on patient complexity and needs. While no universal definition exists, most studies define "early palliative care" as involvement by a palliative team within the first three months following a diagnosis of advanced cancer. This approach is supported by multiple scientific societies. Nevertheless, challenges such as limited resources, accessibility barriers, and increasing in-person demand near the end of life remain significant obstacles.

Among advanced cancers, lung cancer stands out due to its high prevalence and poor prognosis. It is characterized by frequent and unpredictable symptoms, requiring flexible and responsive follow-up. Adapting care to patients' changing needs could improve quality of life, optimize resources, and reduce the frequency of in-person visits.

This study proposes the integration of early palliative care with an e-Health ecosystem, reflecting the global push to bring care into the homes of vulnerable patients using modern technology. Evidence for the impact of ICTs in palliative care remains limited, and existing studies are generally of low quality. To date, only one registered trial (NCT03375489) has explored e-Health in early palliative care. Unlike that study, this research offers a scalable model tailored to patient complexity, alongside a comprehensive cost-utility evaluation (e.g., fewer in-person visits, emergency care use, and patient transfers to care centers).

This is the first international clinical trial of its kind in palliative care. It is a multicenter, randomized, controlled trial with blinded third-party evaluation. The hypothesis is that an e-Health ecosystem with ICT tools will improve access, early detection, monitoring, and remote palliative intervention for lung cancer patients.

Being tested
Standard intervention, E-health intervention
Keywords
Palliative Care, e-Health, Telemedicine, Early Treatment
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard interventionOther

    Routine intervention in the service:

    • Good control: In-person visit every 4 weeks.
    • Poor control: Nurse calls at 1 week to assess and decide on treatment changes, visits, or referral. In-person visit by need or after 1 month.
  • E-health interventionOther

    Combined system using ICT and in-person care. It includes spontaneous use (symptom tracking, messages, reminders via app) and scheduled use:

    • Good symptom control: Basic Telematic Evaluation (BTE) at 1 month. If stable, videoconference at 2 months, BTE at 3 months, and in-person visit at 4 months.
    • Poor symptom control: BTE at 1 week. If warning signs appear, a nurse evaluates by phone and may adjust treatment, schedule a visit (in-person or video), or refer to emergency care. In-person visit by need or after 1 month.
Study groups in NCT07039994
Study groupRoleWhat they receive
E-health follow-upExperimentalNot described
Receives: Other: E-health intervention
Standard follow-upActive comparatorNot described
Receives: Other: Standard intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. FACT-L

    Functional Assessment of Cancer Therapy-Lung Minimum and maximum values: 0-136 worst to best quality of life

    Measured: Baseline, 3, 6, 9 and 12 months

Secondary outcomes (19)
  1. ESAS-r

    Edmonton Symptom Assessment System Minimum and maximum values: 0-1, meaning no symptom to 11 symptoms scored 0-10 /110

    Measured: Baseline, 3, 6, 9 and 12 months

  2. HADS

    Hospital Anxiety and Depression Scale Ranges from 0-42. Higher scores indicate greater anxiety and/or depression symptoms.

    Measured: Baseline, 3, 6, 9 and 12 months

  3. EQ-5D-3L

    European Quality of Life Scale Scale Ranges from 5-15, with 5 being best Quality of Life

    Measured: Baseline, 3, 6, 9 and 12 months

  4. ARMS

    Adherence to Refills and Medications Values ranges from 12 to 48, being 12 maximum adherence to refills

    Measured: Baseline, 3, 6 ,9 and 12 months

  5. CTCAE

    Common Toxicology Criteria for Adverse Events Grade 1. Mild: Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.

    Grade 2. Moderate: Minimal, local, or noninvasive intervention indicated; limitation of age-appropriate instrumental Activities of Daily Living (ADLs).

    Grade 3. Severe or medically significant but not immediately life-threatening: Hospitalization or prolongation of hospitalization indicated; disabling; limits self-care ADLs.

    Grade 4. Life-threatening consequences: Urgent intervention indicated. Grade 5. Death related to adverse event (AE).

    Measured: Baseline, 3, 6, 9 and 12 months

  6. Opioid dose

    Daily oral morphine equivalent dose, in miligrams/day

    Measured: Baseline, 3, 6, 9 and 12 months

  7. Hospitalization rate

    Measured: 3, 6, 9 and 12 months

  8. PSCRCM

    Patient Satisfaction with Cancer-Related Care Measure Scale between 18 to 90, being 18 maximum satisfaction

    Measured: Baseline, 3, 6, 9 and 12 months

  9. Charlson Index

    Comorbidity Scale ranging between 0 to 32, being 0 no comorbidities and 32 all comorbidities of the test

    Measured: Baseline, 3, 6, 9 and 12 months

  10. PPS

    Palliative Performance Scale Percentage (100-10), being 100 normal functionality and 10 patient completely bedridden, no possibility of work, complete depence for selfcare, only able to ingest solids and sleepy or in a coma

    Measured: Baseline, 3, 6, 9 and 12 months

  11. ECOG

    Eastern Cooperative Oncology Group (functionality) Grade 0: The patient is completely asymptomatic and is able to perform normal work and daily life activities.

    Grade 1: The patient has symptoms that prevent them from doing strenuous work but is able to carry out normal daily activities and light work. The patient only stays in bed during nighttime sleep hours.

    Grade 2: The patient is unable to perform any work and has symptoms that force them to stay in bed for several hours during the day, in addition to nighttime, but not exceeding 50% of the day. The individual manages most of their personal needs independently.

    Grade 3: The patient needs to be bedridden for more than half of the day due to symptoms. They require assistance with most activities of daily living, such as dressing.

    Grade 4: The patient needs to be bedridden 100% of the day and requires help with all activities of daily living, such as personal hygiene, moving in bed, and even feeding.

    Grade 5: Patient deceased.

    Measured: Baseline, 3, 6, 9 and 12 months

  12. Pfeiffer questionaire

    Cognitive State Scale between -1 to 9, being -1 intact and 9 severe impairment

    Measured: Baseline, 3, 6, 9 and 12 months

  13. BPI

    Brief Pain Inventory Scale between 0 to 10 to determine maximum, minimum and mean pain in the last 24 hours, being 0 no pain and 10 maximum pain Percentage to determine interference of pain with activities, or to determine pain improvement after medication

    Measured: Baseline, 3, 6, 9 and 12 months

  14. Age

    Number

    Measured: Baseline registry

  15. Sex

    Male or female

    Measured: Baseline

  16. Type of cancer

    Adenocarcinoma, scamous carcinoma or indiferentiated

    Measured: Baseline

  17. Stage

    IA, IB, IIA, IIB, IIIA, IIB, IIIC, IVA or IVB

    Measured: Baseline

  18. Aim of the onco-specific treatment

    Curative, palliative, non-decided or non onco-specific treatment

    Measured: Baseline

  19. Type of onco-specific treatment

    Chemotherapy, radiotherapy, surgery, Inmunotherapy, Targeted Therapy or non-onco-specific treatment

    Measured: Baseline, 3, 6, 9 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2025
  2. Study start24 Dec 2024
  3. Primary completion24 Mar 2028 (estimated)
  4. Study completion24 Jul 2028 (estimated)

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Experimental group - e-Health follow-up, a combined system using ICT and in-person care. It includes spontaneous use (symptom tracking, messages, reminders via app) and scheduled use: * Good symptom control: Basic Telematic Evaluation (BTE) at 1 month. If stable, videoconference at 2 months, BTE at 3 months, and in-person visit at 4 months. * Poor symptom control: BTE at 1 week. If warning signs appear, a nurse evaluates by phone and may adjust treatment, schedule a visit (in-person or video), or refer to emergency care. In-person visit by need or after 1 month. Control group - Standard follow-up: * Good control: In-person visit every 4 weeks. * Poor control: Nurse calls at 1 week to assess and decide on treatment changes, visits, or referral. In-person visit by need or after 1 month.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07039994
Sponsor's protocol ID
AIRPAL-010521
Other IDs
PR274/21
Acronym
AIRPAL
Status last verified
Jun 2025
First submitted
2 Jun 2025
Last updated
26 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Standard intervention and E-health intervention in people with Non-Small Cell Lung Cancer, run by Jesús González 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 26 Jun 2025. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jesús González Barboteo, MD, PhD (932607733 ext. +34, jgonzalez@iconcologia.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

FACT-L (time frame: Baseline, 3, 6, 9 and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 26 Jun 2025.

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