Clinical trial NCT05611450: Mobile Health Application of Disease Self-Management in Non-Small Cell Lung Cancer Patients During Targeted Therapy
Official title: Developing and Testing a Mobile Health Application of Disease Self-Management in Non-Small Cell Lung Cancer Patients During Targeted Therapy: A Mixed-Methods Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non-small Cell Lung Cancer
Keywords: disease self-management
mobile application
target therapy
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2022-11-10
Enrollment: 108
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The study's purpose is to understand the self-management needs of patients with NSCLC receiving targeted therapy, develop a disease self- management application (mHealth Application), and explore the effect of mHealth application on the self-efficacy and health status of patients receiving targeted therapy for NSCLC.

This study adopts a two-group (pre-and-post-test) design experiment. This study is being conducted over a period of 3 years and is divided in two stages. This study enrolled patients with NSCLC in the outpatient clinic and ward of the Division of Chest Medicine in a northern medical center as the research participants. Stage 1 develop a disease self-management application and understands participants' needs by qualitative study. The participants are a purposive sample of 15-20 patients. Data discontinued when theme saturation is achieved. Stage 2 adopted convenient sampling to enroll 108 patients (54 in the experimental group and 54 in the control group) to evaluate the effectiveness of the disease self-management application. After participant's consent was obtained, this study performed the pre-test and randomized the participants. The experimental group received both routine care and the disease self-management App, while the control group received routine care and part of application. This study collected data before the patients received targeted therapy and in months 1, 3, 6, and 9 after treatment initiation.


Eligibility criteria: Inclusion Criteria:

* ≧20 years of age
* diagnosed with advanced NSCLC
* were epidermal growth factor, anaplastic lymphoma kinase...inhibitor-naive

Exclusion Criteria:

* had received other anti-cancer therapy
* were difficulty with verbal expression or cognitive dysfunction

Primary outcomes:
measure: European Organization for Research and Treatment of Cancer 30-item core quality of life questionnaire
timeFrame: change from baseline at 1 month
measure: European Organization for Research and Treatment of Cancer 30-item core quality of life questionnaire
timeFrame: change from baseline at 3 month
measure: European Organization for Research and Treatment of Cancer 30-item core quality of life questionnaire
timeFrame: change from baseline at 6 month
measure: European Organization for Research and Treatment of Cancer 30-item core quality of life questionnaire
timeFrame: change from baseline at 9 month
measure: NCI-CTCAE (ver 5.0) guideline
timeFrame: change from baseline at 1 month
measure: NCI-CTCAE (ver 5.0) guideline
timeFrame: change from baseline at 3 month
measure: NCI-CTCAE (ver 5.0) guideline
timeFrame: change from baseline at 6 month
measure: NCI-CTCAE (ver 5.0) guideline
timeFrame: change from baseline at 9 month
Secondary outcomes:
measure: knowledge and skills with disease self-management questionnaire
timeFrame: change from baseline at 1 month
measure: knowledge and skills with disease self-management questionnaire
timeFrame: change from baseline at 3 month
measure: knowledge and skills with disease self-management questionnaire
timeFrame: change from baseline at 6 month
measure: knowledge and skills with disease self-management questionnaire
timeFrame: change from baseline at 9 month
measure: disease self-efficacy questionnaire
timeFrame: change from baseline at 1 month
measure: disease self-efficacy questionnaire
timeFrame: change from baseline at 3 month
measure: disease self-efficacy questionnaire
timeFrame: change from baseline at 6 month
measure: disease self-efficacy questionnaire
timeFrame: change from baseline at 9 month
measure: Hospital Anxiety and Depression Scale
timeFrame: change from baseline at 1 month
measure: Hospital Anxiety and Depression Scale
timeFrame: change from baseline at 3 month
measure: Hospital Anxiety and Depression Scale
timeFrame: change from baseline at 6 month
measure: Hospital Anxiety and Depression Scale
timeFrame: change from baseline at 9 month
measure: Medical Outcomes Study-Social Support Survey
timeFrame: chang from baseline at 1 month
measure: Medical Outcomes Study-Social Support Survey
timeFrame: chang from baseline at 3 month
measure: Medical Outcomes Study-Social Support Survey
timeFrame: chang from baseline at 6 month
measure: Medical Outcomes Study-Social Support Survey
timeFrame: chang from baseline at 9 month
Other outcomes:
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