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Status unknownNCT05611450Updated Nov 10, 2022

Mobile Health Application of Disease Self-Management in Non-Small Cell Lung Cancer Patients During Targeted Therapy

An interventional study of disease self-management application in Non-small Cell Lung Cancer, sponsored by Chang Gung Memorial Hospital. Status unknown. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2022-11-10.

Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Health services research

The sponsor has not verified this record recently (last verified Nov 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
108
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Non-small Cell Lung Cancer

Keywords

  • disease self-management
  • mobile application
  • target therapy
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 108 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • ≧20 years of age
  • diagnosed with advanced NSCLC
  • were epidermal growth factor, anaplastic lymphoma kinase...inhibitor-naive

Exclusion criteria

Exclusion Criteria:

  • had received other anti-cancer therapy
  • were difficulty with verbal expression or cognitive dysfunction
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
108 participants (estimated)

Study arms

  • Placebo comparator
    routine care

    Other: disease self-management application

  • Experimental
    lung cancer self-management

    Other: disease self-management application

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.

06

What researchers measure

Primary outcomes

  1. European Organization for Research and Treatment of Cancer 30-item core quality of life questionnaire

    assessing participants' quality of life

    Time frame: change from baseline at 1 month

  2. European Organization for Research and Treatment of Cancer 30-item core quality of life questionnaire

    assessing participants' quality of life

    Time frame: change from baseline at 3 month

  3. European Organization for Research and Treatment of Cancer 30-item core quality of life questionnaire

    assessing participants' quality of life

    Time frame: change from baseline at 6 month

  4. European Organization for Research and Treatment of Cancer 30-item core quality of life questionnaire

    assessing participants' quality of life

    Time frame: change from baseline at 9 month

  5. NCI-CTCAE (ver 5.0) guideline

    assessing participants' skin toxicity grade

    Time frame: change from baseline at 1 month

  6. NCI-CTCAE (ver 5.0) guideline

    assessing participants' skin toxicity grade

    Time frame: change from baseline at 3 month

  7. NCI-CTCAE (ver 5.0) guideline

    assessing participants' skin toxicity grade

    Time frame: change from baseline at 6 month

  8. NCI-CTCAE (ver 5.0) guideline

    assessing participants' skin toxicity grade

    Time frame: change from baseline at 9 month

Secondary outcomes

  1. knowledge and skills with disease self-management questionnaire

    assessing participants' knowledge and skill ability with disease self-management

    Time frame: change from baseline at 1 month

  2. knowledge and skills with disease self-management questionnaire

    assessing participants' knowledge and skill ability with disease self-management

    Time frame: change from baseline at 3 month

  3. knowledge and skills with disease self-management questionnaire

    assessing participants' knowledge and skill ability with disease self-management

    Time frame: change from baseline at 6 month

  4. knowledge and skills with disease self-management questionnaire

    assessing participants' knowledge and skill ability with disease self-management

    Time frame: change from baseline at 9 month

  5. disease self-efficacy questionnaire

    assessing participants' self-efficacy with disease self-management

    Time frame: change from baseline at 1 month

  6. disease self-efficacy questionnaire

    assessing participants' self-efficacy with disease self-management

    Time frame: change from baseline at 3 month

  7. disease self-efficacy questionnaire

    assessing participants' self-efficacy with disease self-management

    Time frame: change from baseline at 6 month

  8. disease self-efficacy questionnaire

    assessing participants' self-efficacy with disease self-management

    Time frame: change from baseline at 9 month

  9. Hospital Anxiety and Depression Scale

    assessing participants' anxiety and depression

    Time frame: change from baseline at 1 month

  10. Hospital Anxiety and Depression Scale

    assessing participants' anxiety and depression

    Time frame: change from baseline at 3 month

  11. Hospital Anxiety and Depression Scale

    assessing participants' anxiety and depression

    Time frame: change from baseline at 6 month

  12. Hospital Anxiety and Depression Scale

    assessing participants' anxiety and depression

    Time frame: change from baseline at 9 month

  13. Medical Outcomes Study-Social Support Survey

    assessing participants' social support

    Time frame: chang from baseline at 1 month

  14. Medical Outcomes Study-Social Support Survey

    assessing participants' social support

    Time frame: chang from baseline at 3 month

  15. Medical Outcomes Study-Social Support Survey

    assessing participants' social support

    Time frame: chang from baseline at 6 month

  16. Medical Outcomes Study-Social Support Survey

    assessing participants' social support

    Time frame: chang from baseline at 9 month

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05611450
Lead sponsor
Chang Gung Memorial Hospital
Responsible party
Kang Hua Chen (Associate Professor, Chang Gung Memorial Hospital) — Principal investigator
First posted
Nov 10, 2022
Start date
Nov 22, 2022 (estimated)
Primary completion
Jul 2024 (estimated)
Completion
Jul 2024 (estimated)
Last update
Nov 10, 2022

Study contacts

Kang Hua Chen, PhD
Contact
khc@mail.cgu.edu.tw
+886-2118800 ext. 5211

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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