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Clinical Trials/NCT05611450
NCT05611450
Not yet recruiting
Not Applicable

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 sites108 target enrollmentNovember 22, 2022

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.

Registry
clinicaltrials.gov
Start Date
November 22, 2022
End Date
July 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Chang Gung Memorial Hospital
Responsible Party
Principal Investigator
Principal Investigator

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)

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