Non-small Cell Lung CancerNCT05611450
Mobile Health Application of Disease Self-Management in Non-Small Cell Lung Cancer Patients During Targeted Therapy
A study testing disease self-management application in people with Non-small Cell Lung Cancer, run by Chang Gung Memorial Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- disease self-management application
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- 22 Nov 2022to Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≧20 years of age
- diagnosed with advanced NSCLC
- were epidermal growth factor, anaplastic lymphoma kinase...inhibitor-naive
Who cannot join
- had received other anti-cancer therapy
- were difficulty with verbal expression or cognitive dysfunction
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- disease self-management application
- Keywords
- disease self-management, mobile application, target therapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
disease self-management applicationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| routine care | Placebo comparator | Not described Receives: Other: disease self-management application |
| lung cancer self-management | Experimental | Not described Receives: Other: disease self-management application |
What is being measured
The primary outcome is the main question the study is designed to answer.
European Organization for Research and Treatment of Cancer 30-item core quality of life questionnaire
assessing participants' quality of life
Measured: change from baseline at 1 month
European Organization for Research and Treatment of Cancer 30-item core quality of life questionnaire
assessing participants' quality of life
Measured: change from baseline at 3 month
European Organization for Research and Treatment of Cancer 30-item core quality of life questionnaire
assessing participants' quality of life
Measured: change from baseline at 6 month
European Organization for Research and Treatment of Cancer 30-item core quality of life questionnaire
assessing participants' quality of life
Measured: change from baseline at 9 month
NCI-CTCAE (ver 5.0) guideline
assessing participants' skin toxicity grade
Measured: change from baseline at 1 month
NCI-CTCAE (ver 5.0) guideline
assessing participants' skin toxicity grade
Measured: change from baseline at 3 month
NCI-CTCAE (ver 5.0) guideline
assessing participants' skin toxicity grade
Measured: change from baseline at 6 month
NCI-CTCAE (ver 5.0) guideline
assessing participants' skin toxicity grade
Measured: change from baseline at 9 month
Secondary outcomes (16)
knowledge and skills with disease self-management questionnaire
assessing participants' knowledge and skill ability with disease self-management
Measured: change from baseline at 1 month
knowledge and skills with disease self-management questionnaire
assessing participants' knowledge and skill ability with disease self-management
Measured: change from baseline at 3 month
knowledge and skills with disease self-management questionnaire
assessing participants' knowledge and skill ability with disease self-management
Measured: change from baseline at 6 month
knowledge and skills with disease self-management questionnaire
assessing participants' knowledge and skill ability with disease self-management
Measured: change from baseline at 9 month
disease self-efficacy questionnaire
assessing participants' self-efficacy with disease self-management
Measured: change from baseline at 1 month
disease self-efficacy questionnaire
assessing participants' self-efficacy with disease self-management
Measured: change from baseline at 3 month
disease self-efficacy questionnaire
assessing participants' self-efficacy with disease self-management
Measured: change from baseline at 6 month
disease self-efficacy questionnaire
assessing participants' self-efficacy with disease self-management
Measured: change from baseline at 9 month
Hospital Anxiety and Depression Scale
assessing participants' anxiety and depression
Measured: change from baseline at 1 month
Hospital Anxiety and Depression Scale
assessing participants' anxiety and depression
Measured: change from baseline at 3 month
Hospital Anxiety and Depression Scale
assessing participants' anxiety and depression
Measured: change from baseline at 6 month
Hospital Anxiety and Depression Scale
assessing participants' anxiety and depression
Measured: change from baseline at 9 month
Medical Outcomes Study-Social Support Survey
assessing participants' social support
Measured: chang from baseline at 1 month
Medical Outcomes Study-Social Support Survey
assessing participants' social support
Measured: chang from baseline at 3 month
Medical Outcomes Study-Social Support Survey
assessing participants' social support
Measured: chang from baseline at 6 month
Medical Outcomes Study-Social Support Survey
assessing participants' social support
Measured: chang from baseline at 9 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start22 Nov 2022 (estimated)
- Primary completionJul 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kang Hua Chen, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05611450
- Sponsor's protocol ID
- 202100777B0
- Status last verified
- Nov 2022
- First submitted
- 2 Nov 2022
- Last updated
- 10 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05611450
- Acronym / sponsor ID
- 202100777B0
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- disease self-management, mobile application, target therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 22 Nov 2022 (estimated)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 10 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| routine care | Placebo comparator | Other: disease self-management application |
| lung cancer self-management | Experimental | Other: disease self-management application |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≧20 years of age
- diagnosed with advanced NSCLC
- were epidermal growth factor, anaplastic lymphoma kinase...inhibitor-naive
Key exclusion criteria (2 listed)
- had received other anti-cancer therapy
- were difficulty with verbal expression or cognitive dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| disease self-management applicationThe 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. | Other | lung cancer self-management, routine care |
Primary outcome
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
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
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
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
NCI-CTCAE (ver 5.0) guideline
Time frame: change from baseline at 1 month
assessing participants' skin toxicity grade
NCI-CTCAE (ver 5.0) guideline
Time frame: change from baseline at 3 month
assessing participants' skin toxicity grade
NCI-CTCAE (ver 5.0) guideline
Time frame: change from baseline at 6 month
assessing participants' skin toxicity grade
NCI-CTCAE (ver 5.0) guideline
Time frame: change from baseline at 9 month
assessing participants' skin toxicity grade
16 secondary outcomes
knowledge and skills with disease self-management questionnaire
Time frame: change from baseline at 1 month
knowledge and skills with disease self-management questionnaire
Time frame: change from baseline at 3 month
knowledge and skills with disease self-management questionnaire
Time frame: change from baseline at 6 month
knowledge and skills with disease self-management questionnaire
Time frame: change from baseline at 9 month
disease self-efficacy questionnaire
Time frame: change from baseline at 1 month
disease self-efficacy questionnaire
Time frame: change from baseline at 3 month
disease self-efficacy questionnaire
Time frame: change from baseline at 6 month
disease self-efficacy questionnaire
Time frame: change from baseline at 9 month
Hospital Anxiety and Depression Scale
Time frame: change from baseline at 1 month
Hospital Anxiety and Depression Scale
Time frame: change from baseline at 3 month
Hospital Anxiety and Depression Scale
Time frame: change from baseline at 6 month
Hospital Anxiety and Depression Scale
Time frame: change from baseline at 9 month
Medical Outcomes Study-Social Support Survey
Time frame: chang from baseline at 1 month
Medical Outcomes Study-Social Support Survey
Time frame: chang from baseline at 3 month
Medical Outcomes Study-Social Support Survey
Time frame: chang from baseline at 6 month
Medical Outcomes Study-Social Support Survey
Time frame: chang from baseline at 9 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing disease self-management application in people with Non-small Cell Lung Cancer, run by Chang Gung Memorial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kang Hua Chen, PhD (+886-2118800 ext. 5211, khc@mail.cgu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
European Organization for Research and Treatment of Cancer 30-item core quality of life questionnaire (time frame: change from baseline at 1 month). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2022.