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

NCT07039994 | Recruiting DMC

• 2 other identifiers: AIRPAL-010521PR274/21
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief 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 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. 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.

Conditions

Non-Small Cell Lung Cancer

Keywords

Palliative Care; e-Health; Telemedicine; Early Treatment

Outcome Measures

Primary Outcomes (1)

• FACT-L

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

  Baseline, 3, 6, 9 and 12 months

Secondary Outcomes (19)

• ESAS-r

  Baseline, 3, 6, 9 and 12 months

• HADS

  Baseline, 3, 6, 9 and 12 months

• EQ-5D-3L

  Baseline, 3, 6, 9 and 12 months

• ARMS

  Baseline, 3, 6 ,9 and 12 months

• CTCAE

  Baseline, 3, 6, 9 and 12 months

Study Arms (2)

E-health follow-up

EXPERIMENTAL

Other: E-health intervention

Standard follow-up

ACTIVE COMPARATOR

Other: Standard intervention

Interventions

Standard intervention OTHER

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.

Standard follow-up

E-health intervention OTHER

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.

E-health follow-up

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jesús González: lead
• Institut Català d'Oncologia: collaborator
• Institut d'Investigació Biomèdica de Bellvitge: collaborator

Study Sites (2)

Catalan Institute of Oncology

Badalona, Barcelona, 08916, Spain

NOT YET RECRUITING

Catalan Institute of Oncology

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jesús González Barboteo, MD, PhD

  Catalan Institute of Oncology (ICO)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jesús González Barboteo, MD, PhD

CONTACT

932607733; jgonzalez@iconcologia.net

Miguel Mateu Sanz, PhD

CONTACT

932607733; mmateu@iconcologia.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Model Details: 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.

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: June 26, 2025
• Study Start: December 24, 2024
• Primary Completion (Estimated): March 24, 2028
• Study Completion (Estimated): July 24, 2028
• Last Updated: June 26, 2025

Record last verified: 2025-06

Locations

ES (2)