Applying Mobile Healthcare Education to Improve Cutaneous Self-care Capability

NCT06291688 | Recruiting

• 1 other identifier: 202312004RIND
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

EGFR Gene Mutation; Drug-Related Side Effects and Adverse Reactions; Cancer, Treatment-Related; Cancer

Keywords

Mobile Healthcare education; Game-based learning; Self-care capability; Learning motivation; Quality of life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Investigate the learning motivation towards CADR by self-designed questionnaire at Day 15

  Day 15

• Change from baseline in the score of the quality of life on DLQI questionnaire at Day 15 and Day 30

  Day 1, Day15, Day 30

• Investigate the user-experience of the mobile healthcare education APP by researcher-designed questionnaire at Day 15.

  Day 15

• Change from baseline in the score of the self-care measurement adherence on researcher-designed questionnaire at Day 15 and Day30.

  Day1, Day15, Day30

Other Outcomes (1)

• The correlation among APP usability, learning motivation and self-care capability.

  Day 1, Day 15, Day 30

Study Arms (2)

Game group

EXPERIMENTAL

An educational game regarding common EGFR-related cutaneous adverse drug reactions on a mobile APP

Behavioral: Mobile healthcare education game

Text group

PLACEBO COMPARATOR

An educational text regarding common EGFR-related cutaneous adverse drug reactions on a mobile APP

Behavioral: Mobile healthcare education application

Interventions

Mobile healthcare education game BEHAVIORAL

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.

Game group

Mobile healthcare education application BEHAVIORAL

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.

Text group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100225, Taiwan

RECRUITING

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions; Neoplasms, Second Primary; Neoplasms

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

• Jung-Chen Chang, Phd

  National Taiwan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xin-Yi Lin

CONTACT

886988619601; r11426019@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: March 4, 2024
• Study Start: January 26, 2024
• Primary Completion: December 31, 2025
• Study Completion: January 31, 2026
• Last Updated: March 4, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)