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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| routine care | Placebo Comparator |
| |
| lung cancer self-management | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| disease self-management application | Other | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kang Hua Chen, PhD | Contact | +886-2118800 | 5211 | khc@mail.cgu.edu.tw |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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assessing participants' skin toxicity grade |
| change from baseline at 9 month |
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 |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |