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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05611450
Enrollment
108
Registered
2022-11-10
Start date
2022-11-22
Completion date
2024-07-31
Last updated
2022-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

Keywords

disease self-management, mobile application, target therapy

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.

Interventions

OTHERdisease 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.

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
European Organization for Research and Treatment of Cancer 30-item core quality of life questionnairechange from baseline at 1 monthassessing participants' quality of life
NCI-CTCAE (ver 5.0) guidelinechange from baseline at 1 monthassessing participants' skin toxicity grade

Secondary

MeasureTime frameDescription
knowledge and skills with disease self-management questionnairechange from baseline at 1 monthassessing participants' knowledge and skill ability with disease self-management
disease self-efficacy questionnairechange from baseline at 1 monthassessing participants' self-efficacy with disease self-management
Hospital Anxiety and Depression Scalechange from baseline at 1 monthassessing participants' anxiety and depression
Medical Outcomes Study-Social Support Surveychang from baseline at 1 monthassessing participants' social support

Contacts

Primary ContactKang Hua Chen, PhD
khc@mail.cgu.edu.tw+886-2118800

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026