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

• Sponsor: Chang Gung Memorial Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05611450
• Collaborator: (none)
• Enrollment: 108
• Arms: 2
• Anticipated Duration (Months): 19.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Non-small Cell Lung Cancer	Other: disease self-management application	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 108 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Health Services Research
• 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
• Anticipated Study Start Date: Nov 22, 2022
• Anticipated Primary Completion Date: Jul 1, 2024
• Anticipated Study Completion Date: Jul 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. European Organization for Research and Treatment of Cancer 30-item core quality of life questionnaire [change from baseline at 1 month]

   assessing participants' quality of life

2. European Organization for Research and Treatment of Cancer 30-item core quality of life questionnaire [change from baseline at 3 month]

   assessing participants' quality of life

3. European Organization for Research and Treatment of Cancer 30-item core quality of life questionnaire [change from baseline at 6 month]

   assessing participants' quality of life

4. European Organization for Research and Treatment of Cancer 30-item core quality of life questionnaire [change from baseline at 9 month]

   assessing participants' quality of life

5. NCI-CTCAE (ver 5.0) guideline [change from baseline at 1 month]

   assessing participants' skin toxicity grade

6. NCI-CTCAE (ver 5.0) guideline [change from baseline at 3 month]

   assessing participants' skin toxicity grade

7. NCI-CTCAE (ver 5.0) guideline [change from baseline at 6 month]

   assessing participants' skin toxicity grade

8. NCI-CTCAE (ver 5.0) guideline [change from baseline at 9 month]

   assessing participants' skin toxicity grade

Secondary Outcome Measures

1. knowledge and skills with disease self-management questionnaire [change from baseline at 1 month]

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

2. knowledge and skills with disease self-management questionnaire [change from baseline at 3 month]

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

3. knowledge and skills with disease self-management questionnaire [change from baseline at 6 month]

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

4. knowledge and skills with disease self-management questionnaire [change from baseline at 9 month]

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

5. disease self-efficacy questionnaire [change from baseline at 1 month]

   assessing participants' self-efficacy with disease self-management

6. disease self-efficacy questionnaire [change from baseline at 3 month]

   assessing participants' self-efficacy with disease self-management

7. disease self-efficacy questionnaire [change from baseline at 6 month]

   assessing participants' self-efficacy with disease self-management

8. disease self-efficacy questionnaire [change from baseline at 9 month]

   assessing participants' self-efficacy with disease self-management

9. Hospital Anxiety and Depression Scale [change from baseline at 1 month]

   assessing participants' anxiety and depression

10. Hospital Anxiety and Depression Scale [change from baseline at 3 month]

    assessing participants' anxiety and depression

11. Hospital Anxiety and Depression Scale [change from baseline at 6 month]

    assessing participants' anxiety and depression

12. Hospital Anxiety and Depression Scale [change from baseline at 9 month]

    assessing participants' anxiety and depression

13. Medical Outcomes Study-Social Support Survey [chang from baseline at 1 month]

    assessing participants' social support

14. Medical Outcomes Study-Social Support Survey [chang from baseline at 3 month]

    assessing participants' social support

15. Medical Outcomes Study-Social Support Survey [chang from baseline at 6 month]

    assessing participants' social support

16. Medical Outcomes Study-Social Support Survey [chang from baseline at 9 month]

    assessing participants' social support

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: 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:

• had received other anti-cancer therapy

• were difficulty with verbal expression or cognitive dysfunction

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Chang Gung Memorial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kang Hua Chen, Associate Professor, Chang Gung Memorial Hospital
• ClinicalTrials.gov Identifier: NCT05611450
• Other Study ID Numbers: 202100777B0
• First Posted: Nov 10, 2022
• Last Update Posted: Nov 10, 2022
• Last Verified: Nov 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Kang Hua Chen, Associate Professor, Chang Gung Memorial Hospital: disease self-management; mobile application; target therapy
• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Nov 10, 2022