UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063576 |
|---|---|
| Receipt number | R000072743 |
| Scientific Title | Evaluation of the Feasibility of Early Detection of Immune-Related Adverse Events and Usability of a Smartphone Application in Patients with Liver Cancer Receiving Immune Checkpoint Inhibitor Therapy in an Outpatient Setting: A Single-Arm Exploratory Prospective Study |
| Date of disclosure of the study information | 2026/11/10 |
| Last modified on | 2026/11/10 09:56:36 |
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Basic information
Public title
A Study of the Usability and Usefulness of a Smartphone Application for Early Detection of Adverse Events in Patients with Liver Cancer Receiving Immune Checkpoint Inhibitors
Acronym
Liver Cancer AE App Study
Scientific Title
Evaluation of the Feasibility of Early Detection of Immune-Related Adverse Events and Usability of a Smartphone Application in Patients with Liver Cancer Receiving Immune Checkpoint Inhibitor Therapy in an Outpatient Setting: A Single-Arm Exploratory Prospective Study
Scientific Title:Acronym
Liver Cancer irAE App Feasibility Study
Region
| Japan |
Condition
Condition
Hepatocellular Carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine | Nursing | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to explore the usability (effectiveness, efficiency, and satisfaction) of a smartphone application designed to support the early detection of immune-related adverse events (irAEs) in patients with primary liver cancer receiving immune checkpoint inhibitor (ICI) therapy in an outpatient setting. It also aims to assess the feasibility of early detection of adverse events by healthcare professionals using the application. Additionally, application usage, feedback from patients and healthcare professionals, and areas for improvement will be evaluated to inform future clinical implementation and randomized controlled trials.
Basic objectives2
Others
Basic objectives -Others
Evaluation of the usability of a smartphone application and the feasibility of early detection of immune-related adverse events
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
We will assess the smartphone application's usability using a patient satisfaction questionnaire 6-8 weeks after the application's initiation.
Key secondary outcomes
1. Effectiveness of the Application: The ease of use, clarity of instructions, and comprehensibility of the application interface will be evaluated using a patient usability questionnaire at 3-4 weeks and again at 6-8 weeks after the initiation of application use.
2. Efficiency of the Application: The ease of operation, time required for use, responsiveness, and readability of text will be assessed through a patient usability questionnaire at 3-4 weeks and again at 6-8 weeks.
3. Feasibility of Early Detection of Immune-Related Adverse Events: The feasibility of early detection of adverse events, including immune-related adverse events (irAEs), will be investigated through patient-reported symptoms and the review of these reports by healthcare professionals during the application-use period of 6-8 weeks.
4. User Experience and Areas for Improvement: Patient experiences, perceptions of application functions, and suggestions for improvement will be explored through semi-structured interviews conducted at 3-4 weeks and again at 6-8 weeks.
5. Health-Related Quality of Life: Health-related quality of life will be measured using the EORTC QLQ-C30 and EORTC QLQ-HCC18 questionnaires at baseline, at 3-4 weeks, and at 6-8 weeks.ks.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Patients with primary liver cancer who are receiving immune checkpoint inhibitor (ICI) therapy will use a smartphone application designed to aid in the early detection of immune-related adverse events (irAEs) for 6 to 8 weeks.
After providing written informed consent, research staff will help participants install the application on their smartphones and provide instructions on how to use it. They are expected to report their symptoms whenever they notice changes in their health and must submit symptom reports at least once a week, even if they do not experience any changes.
Healthcare professionals, including physicians and nurses, will review the symptoms reported by patients, which will be stored in a secure cloud-based system. Based on these reports, they may contact patients or recommend a medical consultation as needed.
Questionnaire assessments will be conducted at baseline and again at 3 to 4 weeks and 6 to 8 weeks after the application is initiated. Additionally, semi-structured interviews will take place at 3 to 4 weeks and 6 to 8 weeks to evaluate the application's usability and identify areas for improvement.
The application will serve as a research tool to support routine clinical care. Participants will also be instructed to contact the hospital directly by telephone if they experience any urgent symptoms.
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
1. Patients with primary liver cancer receiving immune checkpoint inhibitor (ICI) therapy at the Department of Gastroenterology, Tokai University Hospital
2. Patients aged 18 years or older
3. Patients without psychiatric disorders or cognitive impairment
4. Patients who can operate a smartphone application independently or with assistance from a cohabiting family member or caregiver
5. Patients who have received sufficient information about the study and provided written informed consent to participate voluntarily
Key exclusion criteria
1. Patients who do not meet the inclusion criteria
2. Patients who are considered unsuitable for participation in this study by the principal investigator or other study investigators
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masako |
| Middle name | |
| Last name | Shomura |
Organization
Tokai University
Division name
Faculty of Nursing, Department of Medicine
Zip code
2591193
Address
Shimokasuya 143, Isehara, Kanagawa, Japan
TEL
0463931121
s-masako@tokai.ac.jp
Public contact
Name of contact person
| 1st name | Masako |
| Middle name | |
| Last name | Shomura |
Organization
Tokai University
Division name
Faculty of Nursing, Department of Medicine
Zip code
2591193
Address
Shimokasuya 143, Isehara, Kanagawa, Japan
TEL
0463931121
Homepage URL
s-masako@tokai.ac.jp
Sponsor or person
Institute
Tokai University
Institute
Department
Personal name
Masako Shomura
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Smileforce Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, Tokai University School of Medicine
Address
143 Shimokasuya, Isehara, Kanagawa 259-1193, Japan
Tel
0463931121
tokai-rec@tokai.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
24R224
Org. issuing International ID_1
Research Ethics Committee, Tokai University School of Medicine
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東海大学医学部付属病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 11 | Month | 10 | 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
13
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
Completed
Date of protocol fixation
| 2025 | Year | 05 | Month | 15 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 09 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 25 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 11 | Month | 10 | Day |
Last modified on
| 2026 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072743
