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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Other: disease self-management application

• Study Type: Interventional
• Enrollment (Anticipated): 108
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kang Hua Chen, PhD; Phone Number: 5211 +886-2118800; Email: khc@mail.cgu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: routine care	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.
Experimental: lung cancer self-management	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
NCI-CTCAE (ver 5.0) guideline	assessing participants' skin toxicity grade	change from baseline at 1 month
NCI-CTCAE (ver 5.0) guideline	assessing participants' skin toxicity grade	change from baseline at 3 month
NCI-CTCAE (ver 5.0) guideline	assessing participants' skin toxicity grade	change from baseline at 6 month
NCI-CTCAE (ver 5.0) guideline	assessing participants' skin toxicity grade	change from baseline at 9 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
knowledge and skills with disease self-management questionnaire	assessing participants' knowledge and skill ability with disease self-management	change from baseline at 1 month
knowledge and skills with disease self-management questionnaire	assessing participants' knowledge and skill ability with disease self-management	change from baseline at 3 month
knowledge and skills with disease self-management questionnaire	assessing participants' knowledge and skill ability with disease self-management	change from baseline at 6 month
knowledge and skills with disease self-management questionnaire	assessing participants' knowledge and skill ability with disease self-management	change from baseline at 9 month
disease self-efficacy questionnaire	assessing participants' self-efficacy with disease self-management	change from baseline at 1 month
disease self-efficacy questionnaire	assessing participants' self-efficacy with disease self-management	change from baseline at 3 month
disease self-efficacy questionnaire	assessing participants' self-efficacy with disease self-management	change from baseline at 6 month
disease self-efficacy questionnaire	assessing participants' self-efficacy with disease self-management	change from baseline at 9 month
Hospital Anxiety and Depression Scale	assessing participants' anxiety and depression	change from baseline at 1 month
Hospital Anxiety and Depression Scale	assessing participants' anxiety and depression	change from baseline at 3 month
Hospital Anxiety and Depression Scale	assessing participants' anxiety and depression	change from baseline at 6 month
Hospital Anxiety and Depression Scale	assessing participants' anxiety and depression	change from baseline at 9 month
Medical Outcomes Study-Social Support Survey	assessing participants' social support	chang from baseline at 1 month
Medical Outcomes Study-Social Support Survey	assessing participants' social support	chang from baseline at 3 month
Medical Outcomes Study-Social Support Survey	assessing participants' social support	chang from baseline at 6 month
Medical Outcomes Study-Social Support Survey	assessing participants' social support	chang from baseline at 9 month

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): November 22, 2022
• Primary Completion (Anticipated): July 1, 2024
• Study Completion (Anticipated): July 1, 2024

Study Registration Dates

• First Submitted: November 2, 2022
• First Submitted That Met QC Criteria: November 9, 2022
• First Posted (Actual): November 10, 2022

Study Record Updates

• Last Update Posted (Actual): November 10, 2022
• Last Update Submitted That Met QC Criteria: November 9, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: target therapy; mobile application; disease self-management
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: 202100777B0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No