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

Not Applicable

Not yet recruiting

• Conditions: Non-small Cell Lung Cancer
• Interventions: Other: disease self-management application

• Registration Number: NCT05611450
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-11
• Study First Submitted: 2022-11-02
• Study First Submitted QC: 2022-11-09
• Last Update Submitted: 2022-11-09
• Study First Posted: 2022-11-10
• Last Update Posted: 2022-11-10
• Study Start: 2022-11-22
• Primary Completion: 2024-07
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 108

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
routine care	disease self-management application	-
lung cancer self-management	disease self-management application	-

Primary Outcome Measures

Name	Time	Method
European Organization for Research and Treatment of Cancer 30-item core quality of life questionnaire	change from baseline at 9 month	assessing participants' quality of life
NCI-CTCAE (ver 5.0) guideline	change from baseline at 9 month	assessing participants' skin toxicity grade

Secondary Outcome Measures

Name	Time	Method
Medical Outcomes Study-Social Support Survey	chang from baseline at 9 month	assessing participants' social support
knowledge and skills with disease self-management questionnaire	change from baseline at 9 month	assessing participants' knowledge and skill ability with disease self-management
disease self-efficacy questionnaire	change from baseline at 9 month	assessing participants' self-efficacy with disease self-management
Hospital Anxiety and Depression Scale	change from baseline at 9 month	assessing participants' anxiety and depression