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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Non-small Cell Lung Cancer
- Sponsor
- Chang Gung Memorial Hospital
- Enrollment
- 108
- Primary Endpoint
- European Organization for Research and Treatment of Cancer 30-item core quality of life questionnaire
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Kang Hua Chen
Associate Professor
Chang Gung Memorial Hospital
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
Outcomes
Primary Outcomes
European Organization for Research and Treatment of Cancer 30-item core quality of life questionnaire
Time Frame: change from baseline at 9 month
assessing participants' quality of life
NCI-CTCAE (ver 5.0) guideline
Time Frame: change from baseline at 9 month
assessing participants' skin toxicity grade
Secondary Outcomes
- Medical Outcomes Study-Social Support Survey(chang from baseline at 9 month)
- knowledge and skills with disease self-management questionnaire(change from baseline at 9 month)
- disease self-efficacy questionnaire(change from baseline at 9 month)
- Hospital Anxiety and Depression Scale(change from baseline at 9 month)