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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
108

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: routine care
Other: disease 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.
Experimental: lung cancer self-management
Other: disease 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chang Gung Memorial Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 22, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 2, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 10, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 10, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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