Early palliative care with e-health support for advanced non-small cell lung cancer
Early Palliative Care in Patients With Advanced Lung Cancer Using an e-Health Ecosystem: a Randomized, Controlled, and Blinded Clinical Trial
This project will test whether adding an e-health telemedicine program to early palliative care helps people with advanced non-small cell lung cancer manage symptoms, emotional needs, and care decisions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Instituto de Salud Carlos III Government |
| Drugs / interventions | radiation |
| Locations | 2 sites (Badalona, Barcelona and 1 other locations) |
| Trial ID | NCT07039994 on ClinicalTrials.gov |
What this trial studies
Patients with advanced (stage III–IV) non-small cell lung cancer seen for an initial palliative consultation are offered either standard palliative care or an integrated e‑health intervention that combines telemedicine visits, remote symptom monitoring, and caregiver support tools. The e‑health arm delivers multidimensional palliative services earlier in the disease course, including symptom management, psychosocial support, and advance care planning, via online platforms and telephone contact. Eligible participants must have internet access and ECOG performance status 0–3, with selection informed by criteria for early palliative intervention such as recent diagnosis, poorly controlled pain, dyspnea, emotional distress, or functional limitations. Primary outcomes include symptom burden, quality of life, health‑care utilization, and caregiver-reported needs measured over scheduled follow-ups.
Who should consider this trial
Good fit: Ideal candidates are adults with advanced (stage III–IV) non-small cell lung cancer seen at an initial palliative consultation who meet early‑palliative criteria, have ECOG 0–3, and have internet access and basic computer/phone skills.
Not a fit: Patients without reliable internet or telephone access, those with severe cognitive impairment or other exclusions for early palliative intervention, or those unable to attend the participating Catalan Oncology centers are unlikely to benefit from the e‑health component.
Why it matters
Potential benefit: If successful, this approach could improve symptom control, reduce unmet needs, and broaden access to palliative care for patients who live farther from specialty centers.
How similar studies have performed: Previous randomized studies of early palliative care in oncology have shown improved symptom control and quality of life, while e‑health delivery in palliative settings has shown promise but remains less well established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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). Exclusion Criteria: * 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.
Where this trial is running
Badalona, Barcelona and 1 other locations
- Catalan Institute of Oncology — Badalona, Barcelona, Spain (Not_yet_recruiting)
- Catalan Institute of Oncology — L'Hospitalet de Llobregat, Barcelona, Spain (Recruiting)
Study contacts
- Principal investigator: Jesús González Barboteo, MD, PhD — Catalan Institute of Oncology (ICO)
- Study coordinator: Jesús González Barboteo, MD, PhD
- Email: jgonzalez@iconcologia.net
- Phone: 932607733
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.