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Not yet recruiting NCT07310589

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

No phase Interventional Non-Small Cell Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Visual-Interactive LINE Chatbot.
Who it may be relevant to
Registry conditions: Non-Small Cell Lung Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

  • 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.

Primary outcome measures

  • Self-Management Ability(PAM-13) [Time frame: at baseline and at 1, 3, and 6 months post-intervention]
Secondary outcome measures (2)
  • Quality of Life Related to EGFR-TKI Treatment(FACT-EGFRI-18) [Time frame: 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT07310589 · 202506172RINB

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗