Mobile Health Application of Disease Self-Management in Non-Small Cell Lung Cancer Patients During Targeted Therapy

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Other: disease self-management application


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: routine care<br> | Other: disease self-management application<br>* The mHealth application provide disease self-management knowledge and skills and also has the functions of level of skin toxicity warning, uploading photos of skin toxicity, and interacting with healthcare professionals.<br>|
| Experimental: lung cancer self-management<br> | Other: disease self-management application<br>* The mHealth application provide disease self-management knowledge and skills and also has the functions of level of skin toxicity warning, uploading photos of skin toxicity, and interacting with healthcare professionals.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| European Organization for Research and Treatment of Cancer 30-item core quality of life questionnaire | assessing participants' quality of life | change from baseline at 1 month | 
| European Organization for Research and Treatment of Cancer 30-item core quality of life questionnaire | assessing participants' quality of life | change from baseline at 3 month | 
| European Organization for Research and Treatment of Cancer 30-item core quality of life questionnaire | assessing participants' quality of life | change from baseline at 6 month | 
| European Organization for Research and Treatment of Cancer 30-item core quality of life questionnaire | assessing participants' quality of life | change from baseline at 9 month | 
| NCI-CTCAE (ver 5.0) guideline | assessing participants' skin toxicity grade | change from baseline at 1 month | 
| NCI-CTCAE (ver 5.0) guideline | assessing participants' skin toxicity grade | change from baseline at 3 month | 
| NCI-CTCAE (ver 5.0) guideline | assessing participants' skin toxicity grade | change from baseline at 6 month | 
| NCI-CTCAE (ver 5.0) guideline | assessing participants' skin toxicity grade | change from baseline at 9 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| knowledge and skills with disease self-management questionnaire | assessing participants' knowledge and skill ability with disease self-management | change from baseline at 1 month | 
| knowledge and skills with disease self-management questionnaire | assessing participants' knowledge and skill ability with disease self-management | change from baseline at 3 month | 
| knowledge and skills with disease self-management questionnaire | assessing participants' knowledge and skill ability with disease self-management | change from baseline at 6 month | 
| knowledge and skills with disease self-management questionnaire | assessing participants' knowledge and skill ability with disease self-management | change from baseline at 9 month | 
| disease self-efficacy questionnaire | assessing participants' self-efficacy with disease self-management | change from baseline at 1 month | 
| disease self-efficacy questionnaire | assessing participants' self-efficacy with disease self-management | change from baseline at 3 month | 
| disease self-efficacy questionnaire | assessing participants' self-efficacy with disease self-management | change from baseline at 6 month | 
| disease self-efficacy questionnaire | assessing participants' self-efficacy with disease self-management | change from baseline at 9 month | 
| Hospital Anxiety and Depression Scale | assessing participants' anxiety and depression | change from baseline at 1 month | 
| Hospital Anxiety and Depression Scale | assessing participants' anxiety and depression | change from baseline at 3 month | 
| Hospital Anxiety and Depression Scale | assessing participants' anxiety and depression | change from baseline at 6 month | 
| Hospital Anxiety and Depression Scale | assessing participants' anxiety and depression | change from baseline at 9 month | 
| Medical Outcomes Study-Social Support Survey | assessing participants' social support | chang from baseline at 1 month | 
| Medical Outcomes Study-Social Support Survey | assessing participants' social support | chang from baseline at 3 month | 
| Medical Outcomes Study-Social Support Survey | assessing participants' social support | chang from baseline at 6 month | 
| Medical Outcomes Study-Social Support Survey | assessing participants' social support | chang from baseline at 9 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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disease self-management, mobile application, target therapy