Non-Small Cell Lung CancerNCT07310589
Effects of a Visual Interactive LINE Chatbot on Self-Management of EGFR-TKI Related Side Effects in Patients With Lung Cancer
A study testing Visual-Interactive LINE Chatbot in people with Non-Small Cell Lung Cancer, run by National Taiwan University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Visual-Interactive LINE Chatbot
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2026to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients diagnosed with a second primary malignancy or multiple malignancies.
- Patients receiving other anticancer treatments.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Visual-Interactive LINE Chatbot
- Keywords
- LINE Chatbot, EGFR-TKIs, side effects, Self-management ability, Quality of life, NSCLC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual-Interactive LINE ChatbotBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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）
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.
Measured: at baseline and at 1, 3, and 6 months post-intervention
Overall User Satisfaction With the LINE Chatbot Intervention (CSQ-8)
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.
Measured: At 3 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start15 Aug 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07310589
- Sponsor's protocol ID
- 202506172RINB
- Status last verified
- May 2026
- First submitted
- 16 Dec 2025
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 35227408Plachouri 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.
PubMed 37370736Galmarini 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.
PubMed 38862966Dan 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.
PubMed 38327269
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07310589
- Acronym / sponsor ID
- 202506172RINB
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- LINE Chatbot, EGFR-TKIs, side effects, Self-management ability, Quality of life, NSCLC
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 30 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| LINE Chatbot Intervention Group | Experimental | Behavioral: Visual-Interactive LINE ChatbotParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients diagnosed with a second primary malignancy or multiple malignancies.
- Patients receiving other anticancer treatments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visual-Interactive LINE ChatbotParticipants 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. | Behavioural | LINE Chatbot Intervention Group |
Primary outcome
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Results publication: PubMed 35227408Lim 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.
- Results publication: PubMed 37370736Plachouri 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.
- Results publication: PubMed 38862966Galmarini 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.
- Results publication: PubMed 38327269Dan 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Visual-Interactive LINE Chatbot in people with Non-Small Cell Lung Cancer, run by National Taiwan University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact LING-SIN HSU, MSN (+886-2-23123456 ext. 266942, a109700@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Management Ability（PAM-13） (time frame: at baseline and at 1, 3, and 6 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07310589, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.