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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 108
- 主要终点
- European Organization for Research and Treatment of Cancer 30-item core quality of life questionnaire
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≧20 years of age
- •diagnosed with advanced NSCLC
- •were epidermal growth factor, anaplastic lymphoma kinase...inhibitor-naive
排除标准
- •had received other anti-cancer therapy
- •were difficulty with verbal expression or cognitive dysfunction
结局指标
主要结局
European Organization for Research and Treatment of Cancer 30-item core quality of life questionnaire
时间窗: change from baseline at 9 month
assessing participants' quality of life
NCI-CTCAE (ver 5.0) guideline
时间窗: change from baseline at 9 month
assessing participants' skin toxicity grade
次要结局
- 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)
研究者
Kang Hua Chen
Associate Professor
Chang Gung Memorial Hospital
