Applying Mobile Healthcare Education to Improve Cutaneous Self-care Capability

The Efficacy of Applying Mobile Healthcare Education to Improve Cutaneous Self-care Capability for Patients Receiving Targeted Therapy

The goal of this clinical interventional study is to compare the efficacy of mobile healthcare education in two ways (game-based or text-based) to improve cutaneous self-care capability in cancer patients receiving EGFR-based target therapy. The main questions it aims to answer are:

Impact of different mobile healthcare education ways on cutaneous self-care capability of patients Impact of different mobile healthcare education ways on learning motivation of patients towards cutaneous self-care knowledge and skills

Participants will be randomly divided into two groups. Both groups will download a healthcare education application on their phone. One group will accept the education about the knowledge and self-care skills of cutaneous adverse drug reaction by playing game. In contrast, the other group will accept the same education content by reading text on the phone. Subjects will be asked to use the application at home for two weeks after giving consent to participate this study, and then completed questionnaire three times during study period. The timepoints of completing questionnaire are listed following:

Baseline / pre-intervention test (after signing informed consent form, D1) First post-intervention test (after finishing intervention, D15) Second post-intervention test (D30) Researchers will compare game group and text group to see if game group has better performance on cutaneous self-care capability and learning motivation.

Study Overview

• Status: Recruiting
• Conditions: Cancer; Drug-Related Side Effects and Adverse Reactions; Cancer, Treatment-Related; EGFR Gene Mutation
• Intervention / Treatment: Behavioral: Mobile healthcare education game; Behavioral: Mobile healthcare education application

Detailed Description

This study is a randomized controlled study. Researchers use a random assignment, parallel two-group pre-test and post-test design to conduct a 1-month interventional study regarding giving health education to patients receiving EGFR-targeted drugs. A total of 3 questionnaires were collected to compare the learning efficacy of giving health education through mobile game and through text. Learning motivation, compliance with prevention care measures, the quality of life and the user experience will be also discussed.

Once the subjects sign the Informed Consent Form, they will be asked to conduct the pre-test questionnaire (D1). Then, the block-randomized assignment will be used to divide subjects into the experimental group or the control group. Both the experimental group and the control group downloaded a health educational APP, regarding cutaneous adverse drug reactions related to EGFR-targeted drugs, on their mobile phones.

After randomization, the researchers will give subjects a randomly generated 4-digit code. Subjects can use this code to log in the APP. After log-in, the subjects in the experimental group will see the interface of an educational game. Meanwhile, the subjects in the control group will see the interface of the text of educational content. Subjects will be asked to play the game or read the text at home for 2 weeks. The subjects will not know the difference between the experimental group and the control group, nor will they know whether they are assigned to the experimental group or the control group, thus maintaining the blindness of the subjects.

After 2 weeks, subjects will be asked to do the first post-test questionnaire (D15) to explore the short-term effect of the APP. Then, they will be encouraged to keep using the APP during the following 2 weeks. At D30, subjects will be asked to do the first post-test questionnaire (D15) to investigate the long-term effect of the APP.

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xin-Yi Lin; Phone Number: 886988619601; Email: r11426019@ntu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 100225
    • Recruiting
    • National Taiwan University Hospital
    • Contact: XinYi Lin, Bs; Phone Number: +886988619601; Email: r11426019@ntu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults whose age is above 18.
• Patients are receiving EGFR-base target drugs now.
• Patients can use smart phone.

Exclusion Criteria:

• Patients with visually impaired, hearing impared or other health related factors cause inability to use smart phone.
• Patients cannot understand study aims and procedures by communicating in Mandarin or Taiwanese.
• Patients cannot follow study procedures.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Game group; An educational game regarding common EGFR-related cutaneous adverse drug reactions on a mobile APP	Behavioral: Mobile healthcare education game; Game group will download an APP on a smart phone and play the mobile game which contains the educaitonal content regarding EGFR-related cutaneous adverse drug reactions.
Placebo Comparator: Text group; An educational text regarding common EGFR-related cutaneous adverse drug reactions on a mobile APP	Behavioral: Mobile healthcare education application; Text group will download an APP on a smart phone and open the APP to see the text regarding EGFR-related cutaneous adverse drug reactions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in the score of cutaneous adverse drug reaction (CADR) knowledge on researcher-designed questionnaire at Day 15 and Day 30.	Comparing the improvement of CADR knowledge between different groups	Day 1, Day 15, Day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigate the learning motivation towards CADR by self-designed questionnaire at Day 15	Compare learning motivations between different groups towards CADR	Day 15
Change from baseline in the score of the quality of life on DLQI questionnaire at Day 15 and Day 30	Compare the quality of life between different groups	Day 1, Day15, Day 30
Investigate the user-experience of the mobile healthcare education APP by researcher-designed questionnaire at Day 15.	Confirm the usability and game-experience of mobile healthcare education APP.	Day 15
Change from baseline in the score of the self-care measurement adherence on researcher-designed questionnaire at Day 15 and Day30.	Compare the self-care measurement adherence between different groups	Day1, Day15, Day30

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The correlation among APP usability, learning motivation and self-care capability.	Investigate the correlation among game usability, learning motivation and self-care capability.	Day 1, Day 15, Day 30

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Jung-Chen Chang, Phd, National Taiwan University

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): January 31, 2026

Study Registration Dates

• First Submitted: February 5, 2024
• First Submitted That Met QC Criteria: February 26, 2024
• First Posted (Estimated): March 4, 2024

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Quality of life; Game-based learning; Mobile Healthcare education; Self-care capability; Learning motivation
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Neoplasms; Drug-Related Side Effects and Adverse Reactions; Neoplasms, Second Primary
• Other Study ID Numbers: 202312004RIND

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