Effects of a Visual Interactive LINE Chatbot on Self-Management of EGFR-TKI Related Side Effects in Patients With Lung Cancer

May 5, 2026 updated by: National Taiwan University Hospital

A Randomized Controlled Trial to Evaluate the Effects of a Visual-Interactive LINE Chatbot on Self-Management of EGFR-TKI-Related Side Effects in Patients With Lung Cancer

This study aims to evaluate a visual interactive LINE chatbot designed to support self-management of treatment-related side effects among patients with advanced lung cancer receiving epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) therapy.

Patients receiving EGFR-TKI treatment often experience long-term side effects that require ongoing self-management. In this randomized controlled trial, participants will be assigned to receive either usual care alone or usual care plus access to the LINE chatbot intervention, which provides visualized and interactive educational content for symptom monitoring and self-care.

The primary outcome of this study is self-management ability related to EGFR-TKI-associated side effects. Secondary outcomes include quality of life during treatment and overall satisfaction with the LINE chatbot intervention.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The objective of this study is to evaluate a visual interactive LINE chatbot designed to support self-management of treatment-related side effects among patients with advanced lung cancer receiving epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) therapy.

This study uses a randomized controlled trial design. Participants will be recruited from a medical center in northern Taiwan and randomly assigned to either an intervention group or a control group. The control group will receive standard education and routine clinical care, while the intervention group will receive standard care plus access to the visual interactive LINE chatbot intervention. The chatbot provides visualized and interactive educational content to support symptom monitoring and self-care during treatment.

Assessments will be conducted at baseline and at multiple follow-up time points after enrollment to evaluate self-management ability related to EGFR-TKI-associated side effects, quality of life during treatment, and overall satisfaction with the chatbot intervention.

Study Type

Interventional

Enrollment (Estimated)

178

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with newly diagnosed stage IIIB to IVB unresectable or inoperable non-small cell lung cancer (NSCLC), or those with first disease recurrence who are receiving oral targeted therapy.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2, with the ability to perform self-care activities.
  • Patients receiving epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) therapy, including gefitinib, erlotinib, afatinib, dacomitinib, or osimertinib.
  • Willingness to participate in the study, with completion of the informed consent process and provision of written informed consent.
  • Ability to communicate in Chinese and to independently operate a smartphone and use the LINE application.

Exclusion Criteria:

  • Patients diagnosed with a second primary malignancy or multiple malignancies.
  • Patients receiving other anticancer treatments.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LINE Chatbot Intervention Group
Participants receive usual care plus access to a visual interactive LINE chatbot designed to support self-management of treatment-related side effects during EGFR-TKI therapy.
Behavioral: Visual-Interactive LINE Chatbot
Participants receive access to a visual-interactive LINE chatbot designed to support self-management of EGFR-TKI-related side effects. The chatbot provides interactive and visualized educational content, symptom monitoring guidance, and self-care recommendations throughout the treatment period, in addition to usual care.
No Intervention: usual care
Participants receive usual care, which consists of standard paper-based educational materials provided as part of routine clinical care, without access to the LINE chatbot.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-Management Ability（PAM-13）
Time Frame: at baseline and at 1, 3, and 6 months post-intervention

Self-management ability is measured using the Patient Activation Measure (PAM-13) developed by Hibbard et al. (2005).

The PAM-13 consists of 13 items assessing an individual's knowledge, skills, and confidence in managing their health or chronic condition.

Each item is rated on a 4-point Likert scale, and raw scores are transformed into a standardized score ranging from 0 to 100, with higher scores indicating greater self-management ability and willingness to engage in self-care.

The Chinese version of the PAM-13 has demonstrated good internal consistency, with a Cronbach's alpha of 0.835.
at baseline and at 1, 3, and 6 months post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life Related to EGFR-TKI Treatment（FACT-EGFRI-18）
Time Frame: at baseline and at 1, 3, and 6 months post-intervention

Quality of life is assessed using the Functional Assessment of Cancer Therapy-Epidermal Growth Factor Receptor Inhibitor 18-item scale (FACT-EGFRI-18) developed by Wagner et al. (2013).

The FACT-EGFRI-18 consists of 18 items evaluating the impact of EGFR-TKI-related dermatologic toxicities on patients' physical, psychological, social, skin, nail, and hair-related well-being.

Items are rated on a 5-point Likert scale, with total scores ranging from 18 to 90.

Higher scores indicate greater symptom burden and poorer quality of life. The Chinese version of the FACT-EGFRI-18 has demonstrated good internal consistency, with Cronbach's alpha values ranging from 0.83 to 0.95.
at baseline and at 1, 3, and 6 months post-intervention
Overall User Satisfaction With the LINE Chatbot Intervention (CSQ-8)
Time Frame: At 3 months after the intervention

User satisfaction is measured using the Client Satisfaction Questionnaire-8 (CSQ-8) developed by Larsen et al. (1979).

The CSQ-8 consists of 8 items assessing overall satisfaction with healthcare or psychosocial interventions.

Each item is rated on a 4-point Likert scale, with total scores ranging from 8 to 32, where higher scores indicate greater satisfaction with the intervention.

The CSQ-8 has demonstrated high internal consistency, with reported Cronbach's alpha values ranging from 0.93 to 0.95.
At 3 months after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

December 16, 2025

First Submitted That Met QC Criteria

December 16, 2025

First Posted (Actual)

December 30, 2025

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202506172RINB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD), including demographic characteristics, intervention assignment, and outcome measure scores (self-management ability, quality of life, and user satisfaction), will be shared. A data dictionary and related study documentation will also be made available. Data will be shared upon reasonable request after publication of the primary study results.

IPD Sharing Time Frame

The data will be available after publication of the primary study results and will be available for a period of five years.

IPD Sharing Access Criteria

Researchers who provide a methodologically sound research proposal may request access to the data. Requests will be reviewed by the study investigators, and access will be granted following approval and execution of a data use agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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