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

Chang Gung Medical Foundation

Status: Not yet enrolling

Conditions: Non-small Cell Lung Cancer

Treatments: Other: disease self-management application

Study type: Interventional

Funder types: Other

Identifiers

NCT05611450

202100777B0

Details and patient eligibility

About

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.

Enrollment: 108 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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108 participants in 2 patient groups, including a placebo group

routine care

Placebo Comparator group

Treatment:

Other: disease self-management application

lung cancer self-management

Experimental group

Treatment:

Other: disease self-management application