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

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05611450
• Other study ID #: 202100777B0
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 22, 2022
• Est. completion date: July 2024

Study information

• Verified date: November 2022
• Source: Chang Gung Memorial Hospital
• Contact: Kang Hua Chen, PhD
• Phone: +886-2118800
• Email: khc[@]mail.cgu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 108
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Other:
• disease self-management application
The mHealth application provide disease self-management knowledge and skills and also has the functions of level of skin toxicity warning, uploading photos of skin toxicity, and interacting with healthcare professionals.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	European Organization for Research and Treatment of Cancer 30-item core quality of life questionnaire	assessing participants' quality of life	change from baseline at 1 month
Primary	European Organization for Research and Treatment of Cancer 30-item core quality of life questionnaire	assessing participants' quality of life	change from baseline at 3 month
Primary	European Organization for Research and Treatment of Cancer 30-item core quality of life questionnaire	assessing participants' quality of life	change from baseline at 6 month
Primary	European Organization for Research and Treatment of Cancer 30-item core quality of life questionnaire	assessing participants' quality of life	change from baseline at 9 month
Primary	NCI-CTCAE (ver 5.0) guideline	assessing participants' skin toxicity grade	change from baseline at 1 month
Primary	NCI-CTCAE (ver 5.0) guideline	assessing participants' skin toxicity grade	change from baseline at 3 month
Primary	NCI-CTCAE (ver 5.0) guideline	assessing participants' skin toxicity grade	change from baseline at 6 month
Primary	NCI-CTCAE (ver 5.0) guideline	assessing participants' skin toxicity grade	change from baseline at 9 month
Secondary	knowledge and skills with disease self-management questionnaire	assessing participants' knowledge and skill ability with disease self-management	change from baseline at 1 month
Secondary	knowledge and skills with disease self-management questionnaire	assessing participants' knowledge and skill ability with disease self-management	change from baseline at 3 month
Secondary	knowledge and skills with disease self-management questionnaire	assessing participants' knowledge and skill ability with disease self-management	change from baseline at 6 month
Secondary	knowledge and skills with disease self-management questionnaire	assessing participants' knowledge and skill ability with disease self-management	change from baseline at 9 month
Secondary	disease self-efficacy questionnaire	assessing participants' self-efficacy with disease self-management	change from baseline at 1 month
Secondary	disease self-efficacy questionnaire	assessing participants' self-efficacy with disease self-management	change from baseline at 3 month
Secondary	disease self-efficacy questionnaire	assessing participants' self-efficacy with disease self-management	change from baseline at 6 month
Secondary	disease self-efficacy questionnaire	assessing participants' self-efficacy with disease self-management	change from baseline at 9 month
Secondary	Hospital Anxiety and Depression Scale	assessing participants' anxiety and depression	change from baseline at 1 month
Secondary	Hospital Anxiety and Depression Scale	assessing participants' anxiety and depression	change from baseline at 3 month
Secondary	Hospital Anxiety and Depression Scale	assessing participants' anxiety and depression	change from baseline at 6 month
Secondary	Hospital Anxiety and Depression Scale	assessing participants' anxiety and depression	change from baseline at 9 month
Secondary	Medical Outcomes Study-Social Support Survey	assessing participants' social support	chang from baseline at 1 month
Secondary	Medical Outcomes Study-Social Support Survey	assessing participants' social support	chang from baseline at 3 month
Secondary	Medical Outcomes Study-Social Support Survey	assessing participants' social support	chang from baseline at 6 month
Secondary	Medical Outcomes Study-Social Support Survey	assessing participants' social support	chang from baseline at 9 month