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Telehealth in specialist palliative care in patients with advanced lung cancer: A randomized controlled trial

Telehealth in specialist palliative care in patients with advanced lung cancer: A multicenter randomized controlled trial - Tele-EPC trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000061544
Enrollment
90
Registered
2026-06-01
Start date
2026-07-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Lung Cancer (advanced non-small-cell or advanced small-cell lung cancer)

Interventions

Patients in the intervention group will receive telehealth palliative care consultations at baseline and at 4, 8, and 12 weeks. Patients will receive standard oncological care from their treating phys

Sponsors

Nagoya University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: -Aged 18 years or older. -Currently receiving anti-cancer therapy* at a participating institution. * Including cytotoxic chemotherapy, targeted therapy, and immune checkpoint inhibitors. -Estimated life expectancy of at least 6 months, as determined by the treating physician. -Diagnosed with advanced* non-small cell lung cancer (NSCLC) or advanced* small cell lung cancer (SCLC). * Definition of advanced disease: NSCLC (Stage III/IV) not eligible for curative-intent treatment (surgery or radiotherapy); or SCLC (extensive-stage, limited-stage ineligible for radiotherapy, or recurrent disease). -Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3. -Able to communicate and respond to questions in Japanese.

Exclusion criteria

Exclusion criteria: -Prior receipt of specialist palliative care.* *Defined as having two or more previous visits to a palliative care outpatient clinic. -Inability to operate a tablet or similar device, lack of a home internet connection, or difficulty accessing the standardized online platform for online palliative care consultations, as determined by the treating physician. -Considered unsuitable for study participation by the treating physician due to psychiatric condition or cognitive function.

Design outcomes

Primary

MeasureTime frame
Quality of life, assessed by the Functional Assessment of Cancer Therapy-Lung (FACT-L) score at 12 weeks.

Secondary

MeasureTime frame
1.Quality of life: FACT-L Trial Outcome Index (TOI) assessed at baseline, 4, 8, and 12 weeks. 2.Symptom burden: Revised Edmonton Symptom Assessment System Japanese version (ESAS-r-j) assessed at baseline, 4, 8, and 12 weeks. 3.Depression: Patient Health Questionnaire-9 (PHQ-9) assessed at baseline, 4, 8, and 12 weeks. 4.Health economic evaluation (Effect indicator): Quality-Adjusted Life Years (QALYs) calculated from the EQ-5D-5L at baseline and 12 weeks. Health economic evaluation (Cost indicator): Total costs estimated from intervention costs, medical resource utilization (e.g., unplanned admissions, ER visits), and patient costs (e.g., transportation). 5.Acute care utilization: Unplanned hospital admissions, and unplanned outpatient/ER visits assessed monthly during the 12-week intervention period. 6.Intervention fidelity: Assessment of adherence to the intervention protocol (categorized as Low, Moderate, or High).

Countries

Japan

Contacts

Public ContactArisa Kawashima

Nagoya University Graduate School of Medicine Division of Integrated Health Sciences

kawashima.arisa.s9@f.mail.nagoya-u.ac.jp052-719-1109

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026