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

NCT05611450 | Unknown DMC

• 1 other identifier: 202100777B0
• Study Type: interventional
• Target: 108
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Non-small Cell Lung Cancer

Keywords

disease self-management; mobile application; target therapy

Outcome Measures

Primary Outcomes (8)

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

  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

  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

  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

  assessing participants' quality of life

  change from baseline at 9 month

• NCI-CTCAE (ver 5.0) guideline

  assessing participants' skin toxicity grade

  change from baseline at 1 month

• NCI-CTCAE (ver 5.0) guideline

  assessing participants' skin toxicity grade

  change from baseline at 3 month

• NCI-CTCAE (ver 5.0) guideline

  assessing participants' skin toxicity grade

  change from baseline at 6 month

• NCI-CTCAE (ver 5.0) guideline

  assessing participants' skin toxicity grade

  change from baseline at 9 month

Secondary Outcomes (16)

• knowledge and skills with disease self-management questionnaire

  change from baseline at 1 month

• knowledge and skills with disease self-management questionnaire

  change from baseline at 3 month

• knowledge and skills with disease self-management questionnaire

  change from baseline at 6 month

• knowledge and skills with disease self-management questionnaire

  change from baseline at 9 month

• disease self-efficacy questionnaire

  change from baseline at 1 month

Study Arms (2)

routine care

PLACEBO COMPARATOR

Other: disease self-management application

lung cancer self-management

EXPERIMENTAL

Other: disease self-management application

Interventions

disease self-management application OTHER

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.

lung cancer self-management; routine care

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Kang Hua Chen, PhD

CONTACT

+886-2118800; khc@mail.cgu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 2, 2022
• First Posted: November 10, 2022
• Study Start: November 22, 2022
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: November 10, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share