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

NCT ID: NCT05611450

Last Updated: 2022-11-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-22
• Study Completion Date: 2024-07-31

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.

Conditions

Non-small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

routine care

Group Type: PLACEBO_COMPARATOR

disease self-management application

Intervention Type: OTHER

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.

lung cancer self-management

Group Type: EXPERIMENTAL

disease self-management application

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kang Hua Chen

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Kang Hua Chen, PhD

Role: CONTACT

khc@mail.cgu.edu.tw

+886-2118800 ext. 5211

Other Identifiers

202100777B0

Identifier Type: -

Identifier Source: org_study_id