UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061544 |
|---|---|
| Receipt number | R000069520 |
| Scientific Title | Telehealth in specialist palliative care in patients with advanced lung cancer: A multicenter randomized controlled trial |
| Date of disclosure of the study information | 2026/06/01 |
| Last modified on | 2026/05/13 02:43:26 |
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Basic information
Public title
Telehealth in specialist palliative care in patients with advanced lung cancer: A randomized controlled trial
Acronym
Tele-EPC trial
Scientific Title
Telehealth in specialist palliative care in patients with advanced lung cancer: A multicenter randomized controlled trial
Scientific Title:Acronym
Tele-EPC trial
Region
| Japan |
Condition
Condition
Advanced Lung Cancer (advanced non-small-cell or advanced small-cell lung cancer)
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of a telehealth palliative care intervention compared with usual care in improving quality of life (FACT-L total score) at 12 weeks in patients with advanced lung cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Quality of life, assessed by the Functional Assessment of Cancer Therapy-Lung (FACT-L) score at 12 weeks.
Key secondary outcomes
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).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Patients in the intervention group will receive telehealth palliative care consultations at baseline and at 4, 8, and 12 weeks.
Interventions/Control_2
Patients will receive standard oncological care from their treating physicians. Access to face-to-face specialist palliative care at their own institution is not restricted if deemed necessary by the treating physician or requested by the patient.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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.
Key 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.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Taiki |
| Middle name | |
| Last name | Furukawa |
Organization
Nagoya University Hospital
Division name
Medical IT Center
Zip code
466-8560
Address
65 Tsurumai-Cho, Showa-Ku, Nagoya-City, Aichi
TEL
052-744-1977
furukawa.taiki.u7@f.mail.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Arisa |
| Middle name | |
| Last name | Kawashima |
Organization
Nagoya University Graduate School of Medicine
Division name
Division of Integrated Health Sciences
Zip code
461-8673
Address
1-1-20 Daiko-Minami, Higashi-ku, Nagoya-City, Aichi
TEL
052-719-1109
Homepage URL
https://tele-epc.med.nagoya-u.ac.jp/
kawashima.arisa.s9@f.mail.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya university, Department of Ethics Review Committee
Address
65 Tsurumai-Cho, Showa-Ku, Nagoya-City, Aichi
Tel
052-741-2111
ethics@med.nagoya-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 04 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2027 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2028 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 05 | Month | 13 | Day |
Last modified on
| 2026 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069520
