Mobile Health Application of Disease Self-Management in Non-Small Cell Lung Cancer Patients During Targeted Therapy
November 9, 2022 updated by: Kang Hua Chen, Chang Gung Memorial Hospital
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
108
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kang Hua Chen, PhD
- Phone Number: 5211 +886-2118800
- Email: khc@mail.cgu.edu.tw
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: routine care
|
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
|
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
Time Frame: change from baseline at 1 month
|
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
Time Frame: change from baseline at 3 month
|
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
Time Frame: change from baseline at 6 month
|
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
Time Frame: change from baseline at 9 month
|
assessing participants' quality of life
|
change from baseline at 9 month
|
|
NCI-CTCAE (ver 5.0) guideline
Time Frame: change from baseline at 1 month
|
assessing participants' skin toxicity grade
|
change from baseline at 1 month
|
|
NCI-CTCAE (ver 5.0) guideline
Time Frame: change from baseline at 3 month
|
assessing participants' skin toxicity grade
|
change from baseline at 3 month
|
|
NCI-CTCAE (ver 5.0) guideline
Time Frame: change from baseline at 6 month
|
assessing participants' skin toxicity grade
|
change from baseline at 6 month
|
|
NCI-CTCAE (ver 5.0) guideline
Time Frame: change from baseline at 9 month
|
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
Time Frame: change from baseline at 1 month
|
assessing participants' knowledge and skill ability with disease self-management
|
change from baseline at 1 month
|
|
knowledge and skills with disease self-management questionnaire
Time Frame: change from baseline at 3 month
|
assessing participants' knowledge and skill ability with disease self-management
|
change from baseline at 3 month
|
|
knowledge and skills with disease self-management questionnaire
Time Frame: change from baseline at 6 month
|
assessing participants' knowledge and skill ability with disease self-management
|
change from baseline at 6 month
|
|
knowledge and skills with disease self-management questionnaire
Time Frame: change from baseline at 9 month
|
assessing participants' knowledge and skill ability with disease self-management
|
change from baseline at 9 month
|
|
disease self-efficacy questionnaire
Time Frame: change from baseline at 1 month
|
assessing participants' self-efficacy with disease self-management
|
change from baseline at 1 month
|
|
disease self-efficacy questionnaire
Time Frame: change from baseline at 3 month
|
assessing participants' self-efficacy with disease self-management
|
change from baseline at 3 month
|
|
disease self-efficacy questionnaire
Time Frame: change from baseline at 6 month
|
assessing participants' self-efficacy with disease self-management
|
change from baseline at 6 month
|
|
disease self-efficacy questionnaire
Time Frame: change from baseline at 9 month
|
assessing participants' self-efficacy with disease self-management
|
change from baseline at 9 month
|
|
Hospital Anxiety and Depression Scale
Time Frame: change from baseline at 1 month
|
assessing participants' anxiety and depression
|
change from baseline at 1 month
|
|
Hospital Anxiety and Depression Scale
Time Frame: change from baseline at 3 month
|
assessing participants' anxiety and depression
|
change from baseline at 3 month
|
|
Hospital Anxiety and Depression Scale
Time Frame: change from baseline at 6 month
|
assessing participants' anxiety and depression
|
change from baseline at 6 month
|
|
Hospital Anxiety and Depression Scale
Time Frame: change from baseline at 9 month
|
assessing participants' anxiety and depression
|
change from baseline at 9 month
|
|
Medical Outcomes Study-Social Support Survey
Time Frame: chang from baseline at 1 month
|
assessing participants' social support
|
chang from baseline at 1 month
|
|
Medical Outcomes Study-Social Support Survey
Time Frame: chang from baseline at 3 month
|
assessing participants' social support
|
chang from baseline at 3 month
|
|
Medical Outcomes Study-Social Support Survey
Time Frame: chang from baseline at 6 month
|
assessing participants' social support
|
chang from baseline at 6 month
|
|
Medical Outcomes Study-Social Support Survey
Time Frame: chang from baseline at 9 month
|
assessing participants' social support
|
chang from baseline at 9 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.