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Trial Title:
Mobile Health Application of Disease Self-Management in Non-Small Cell Lung Cancer Patients During Targeted Therapy
NCT ID:
NCT05611450
Condition:
Non-small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords:
disease self-management
mobile application
target therapy
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Health Services Research
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Other
Intervention name:
disease self-management application
Description:
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.
Arm group label:
lung cancer self-management
Arm group label:
routine care
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.
Criteria for 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
Gender:
All
Minimum age:
20 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
November 22, 2022
Completion date:
July 2024
Lead sponsor:
Agency:
Chang Gung Memorial Hospital
Agency class:
Other
Source:
Chang Gung Memorial Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05611450
