UMIN-ICDS Clinical Trial

Public title

A Study of the Feasibility and Acceptability of a Symptom-Reporting App for Patients with Hepatocellular Carcinoma Receiving Immune Checkpoint Inhibitor Therapy

Acronym

HCC-PRO App Study

Scientific Title

Multidimensional Evaluation of the Feasibility and Acceptability of a Patient-Reporting Application Among Outpatients with Hepatocellular Carcinoma Receiving Immune Checkpoint Inhibitor Therapy: A Prospective, Single-Arm, Exploratory Study

Scientific Title:Acronym

HCC-PRO App Study

Region

Japan

Condition

Hepatocellular Carcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine

Nursing

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

This study aims to evaluate the feasibility, acceptability, and operational challenges of a patient-reporting application designed for outpatients with hepatocellular carcinoma who are receiving systemic therapy, including immune checkpoint inhibitors. Participants will use the application for approximately 6 to 8 weeks to report their symptoms, provide free-text information, and submit images when necessary. The study will also investigate the application's potential to identify and communicate adverse events, particularly immune-related adverse events, and will assess its acceptability among both patients and healthcare professionals. It is important to note that this application is not intended to replace established clinical communication, emergency consultations, medical assessments, or treatment decisions.

Basic objectives2

Others

Basic objectives -Others

Exploratory evaluation of the feasibility, usability, patient and healthcare professional acceptability, and potential utility of a patient-reporting application in supporting adverse event identification and communication.

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Ongoing adherence to symptom reporting via the patient application will be evaluated based on usage logs during the 6 to 8 weeks study period.

Key secondary outcomes

1. Application Usage (Over 8 Weeks): Analyze symptom report frequency, periods of no reporting, image uploads, completion rates, discontinuation rates, and reasons for discontinuation.
2. Usability and Acceptability (Weeks 4 and 8 or Upon Discontinuation): Assess ease of use, satisfaction, reporting burden, sustainability, and willingness to continue using the application through questionnaires and interviews.
3. Utility in Adverse Event Identification (Over 8 Weeks): Examine how many reports led to healthcare reviews, consultations, or interactions with physicians, and identify any event changes or findings before routine contacts.
4. Role in Communication and Outpatient Care (Over 8 Weeks): Evaluate cases where application reporting facilitated clinical information sharing or prompted medical consultations.
5. Associations with Patient Characteristics (At Baseline, Weeks 4, and 8 or Upon Discontinuation): Analyze the correlation between factors like age, sex, treatment regimen, and smartphone familiarity with reporting and usability.
6. Operational Challenges and Improvements (Weeks 4 and 8 or Upon Discontinuation): Identify barriers to application use, burdens on users, safety concerns, and areas for enhancement based on feedback and operational records.

Study type

Interventional

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

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Patients with hepatocellular carcinoma who provide written informed consent will use a research purpose patient reporting application for approximately 6 to 8 weeks. Study personnel will provide initial setup assistance and instructions. Participants will report symptoms, free text information, and images when necessary, particularly for skin related symptoms, whenever symptoms occur and approximately once weekly even when asymptomatic. Healthcare professionals may review the reported information as supplementary clinical information and, when clinically indicated, conduct telephone assessments, recommend medical consultation, or communicate with the treating physician within routine clinical care. The application will not replace emergency communication or clinical decision-making. No changes to medication administration, examinations, consultations, or treatment decisions will be made for research purposes.

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

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Patients with hepatocellular carcinoma receiving systemic therapy that includes immune checkpoint inhibitors at the Department of Gastroenterology, Tokai University Hospital.
2. Adults aged 18 years or older.
3. Patients who provide written informed consent to participate in the study.
4. Patients who are able to use a smartphone application independently or with assistance from family members or others.
5. Patients considered eligible for study participation by their treating physician.

Key exclusion criteria

1. Patients who are unable to adequately understand the study explanation due to severe cognitive impairment or similar conditions.
2. Patients considered unsuitable for study participation by the principal investigator or study personnel due to their physical or psychological condition.
3. Patients otherwise considered unsuitable for study participation by the principal investigator or study personnel for health-related or ethical reasons.

Target sample size

50

Name of lead principal investigator

1st name	Masako
Middle name
Last name	Shomura

Organization

Tokai University

Division name

Department of Fundamental Nursing, Faculty of Nursing, School of Medicine

Zip code

259-1193

Address

143 Shimokasuya, Isehara, Kanagawa 259-1193, Japan

TEL

0463931121

Email

s-masako@tokai.ac.jp

Name of contact person

1st name	Masako
Middle name
Last name	Shomura

Organization

Tokai University

Division name

Department of Fundamental Nursing, Faculty of Nursing, School of Medicine

Zip code

2591193

Address

143 Shimokasuya, Isehara, Kanagawa 259-1193, Japan

TEL

0463931121

Homepage URL

Email

s-masako@tokai.ac.jp

Institute

Tokai University

Institute

Department

Personal name

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Smileforce Co., Ltd.

Name of secondary funder(s)

Organization

Research Ethics Committee, Tokai University School of Medicine

Address

143 Shimokasuya, Isehara, Kanagawa 259-1193, Japan

Tel

0463-93-1121

Email

tokai-rec@tokai.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東海大学医学部付属病院（神奈川県）

Date of disclosure of the study information

2026

Year

11

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Enrolling by invitation

Date of protocol fixation

2026

Year

07

Month

07

Day

Date of IRB

2026

Year

08

Month

18

Day

Anticipated trial start date

2026

Year

11

Month

12

Day

Last follow-up date

2029

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related 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=R000072756