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临床试验/NCT05611450
NCT05611450Unknown不适用

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

Chang Gung Memorial Hospital0 个研究点目标入组 108 人开始时间: 2022年11月22日最近更新:
适应症

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

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

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kang Hua Chen

Associate Professor

Chang Gung Memorial Hospital

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