Wpływ wizualnego interaktywnego bota czatowego LINE na samodzielne zarządzanie skutkami ubocznymi związanymi z inhibitorami kinazy tyrozynowej receptora naskórkowego czynnika wzrostu (EGFR-TKI) u pacjentów z rakiem płuca
Randomizowane badanie kontrolowane oceniające wpływ wizualno-interaktywnego bota czatu LINE na samodzielne zarządzanie działaniami niepożądanymi związanymi z inhibitorami kinazy tyrozynowej receptora naskórkowego czynnika wzrostu u pacjentów z rakiem płuca
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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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 studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: LING-SIN HSU, MSN
- Numer telefonu: 266942 +886-2-23123456
- E-mail: a109700@ntuh.gov.tw
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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. |
|
Brak interwencji: 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 mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Self-Management Ability（PAM-13）
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Quality of Life Related to EGFR-TKI Treatment（FACT-EGFRI-18）
Ramy czasowe: 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)
Ramy czasowe: 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
|
Współpracownicy i badacze
Publikacje i pomocne linki
Publikacje ogólne
- 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.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 202506172RINB
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu 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.
Ramy czasowe udostępniania IPD
The data will be available after publication of the primary study results and will be available for a period of five years.
Kryteria dostępu do udostępniania 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 informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .