Efekt vizuálního interaktivního chatbotu LINE na samozvládání vedlejších účinků spojených s EGFR-TKI u pacientů s rakovinou plic
Randomizovaná kontrolovaná studie k vyhodnocení účinků vizuálně-interaktivního LINE chatbotu na samostatné zvládání vedlejších účinků souvisejících s EGFR-TKI u pacientů s rakovinou plic
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: LING-SIN HSU, MSN
- Telefonní číslo: 266942 +886-2-23123456
- E-mail: a109700@ntuh.gov.tw
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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. |
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. |
|
Žádný zásah: 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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Self-Management Ability（PAM-13）
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Quality of Life Related to EGFR-TKI Treatment（FACT-EGFRI-18）
Časové okno: 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)
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Publikace a užitečné odkazy
Obecné publikace
- 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.
- 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.
- 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.
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 202506172RINB
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
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.
Časový rámec sdílení IPD
The data will be available after publication of the primary study results and will be available for a period of five years.
Kritéria přístupu pro sdílení IPD
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.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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