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

NCT07310589 | Not Yet Recruiting

• 1 other identifier: 202506172RINB
• Study Type: interventional
• Target: 178
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Non-Small Cell Lung Cancer

Keywords

LINE Chatbot; EGFR-TKIs; side effects; Self-management ability; Quality of life; NSCLC

Outcome Measures

Primary Outcomes (1)

• Self-Management Ability（PAM-13）

  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 Outcomes (2)

• Quality of Life Related to EGFR-TKI Treatment（FACT-EGFRI-18）

  at baseline and at 1, 3, and 6 months post-intervention

• Overall User Satisfaction With the LINE Chatbot Intervention (CSQ-8)

  At 3 months after the intervention

Study Arms (2)

LINE Chatbot Intervention Group

EXPERIMENTAL

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

usual care

NO INTERVENTION

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.

Interventions

Visual-Interactive LINE Chatbot BEHAVIORAL

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.

LINE Chatbot Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Related Publications (4)

• Lim SM, Shiau CWC, Cheng LJ, Lau Y. Chatbot-Delivered Psychotherapy for Adults With Depressive and Anxiety Symptoms: A Systematic Review and Meta-Regression. Behav Ther. 2022 Mar;53(2):334-347. doi: 10.1016/j.beth.2021.09.007. Epub 2021 Oct 12.

  PMID: 35227408 RESULT

• Plachouri KM, Florou V, Georgiou V, Georgiou S. Cutaneous Side Effects of Modern Targeted Therapy and Immunotherapy in Patients with Dermatological Malignancies. Cancers (Basel). 2023 Jun 9;15(12):3126. doi: 10.3390/cancers15123126.

  PMID: 37370736 RESULT

• Galmarini E, Marciano L, Schulz PJ. The effectiveness of visual-based interventions on health literacy in health care: a systematic review and meta-analysis. BMC Health Serv Res. 2024 Jun 11;24(1):718. doi: 10.1186/s12913-024-11138-1.

  PMID: 38862966 RESULT

• Dan H, Jiang Q, Jia X, Qi G, Zong D, Li Z. Dermatologic toxicities in epidermal growth factor receptor: a comprehensive pharmacovigilance study from 2013 to 2023. Front Med (Lausanne). 2024 Jan 24;10:1283807. doi: 10.3389/fmed.2023.1283807. eCollection 2023.

  PMID: 38327269 RESULT

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

LING-SIN HSU, MSN

CONTACT

+886-2-23123456; a109700@ntuh.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned in a 1:1 ratio to either an intervention group receiving usual care plus access to a visual interactive LINE chatbot or a control group receiving usual care alone.

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: December 30, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will be available after publication of the primary study results and will be available for a period of five years.
• 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.