UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057859 |
|---|---|
| Receipt number | R000066097 |
| Scientific Title | Telehealth in Early Palliative Care for Patients with Advanced Non-Small Cell Lung Cancer: A Multicenter Single-Arm Pilot Study |
| Date of disclosure of the study information | 2025/07/01 |
| Last modified on | 2025/05/14 01:39:56 |
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Basic information
Public title
Telehealth in Early Palliative Care for Patients with Advanced Non-Small Cell Lung Cancer: A Pilot Study
Acronym
Tele-EPC: A Pilot Trial
Scientific Title
Telehealth in Early Palliative Care for Patients with Advanced Non-Small Cell Lung Cancer: A Multicenter Single-Arm Pilot Study
Scientific Title:Acronym
Tele-EPC: A Pilot Trial
Region
| Japan |
Condition
Condition
Advanced Non-Small Cell Lung Cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the feasibility of conducting a future randomized controlled trial of telehealth in early palliative care consultations for patients with advanced non-small cell lung cancer, and to identify technical and operational challenges associated with delivering telehealth in palliative care.
Basic objectives2
Others
Basic objectives -Others
Feasibility
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Retention rate at 4 weeks after the initial palliative care intervention
Key secondary outcomes
1. Patient acceptability and satisfaction
2. Technical issues encountered during the intervention
3. Quality of Life (measured by FACT-L)
4. Symptom burden (measured by ESAS-r)
5. Reasons for discontinuation of the intervention
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Participants will receive telehealth in palliative care at enrollment (baseline) and 1 month later.
Interventions/Control_2
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 cancer treatment
- Diagnosed with advanced non-small cell lung cancer within the past 12 weeks
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 3
- Able to respond to study questionnaires in Japanese
Key exclusion criteria
- Prior history of receiving palliative care interventions
- Inappropriate for study participation due to psychiatric condition or cognitive impairment
Target sample size
5
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
052-719-1949
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
| 2025 | Year | 07 | 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
| 2025 | Year | 05 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 05 | Month | 14 | Day |
Last modified on
| 2025 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066097
