Applying Mobile Healthcare Education to Improve Cutaneous Self-care Capability

NCT ID: NCT06291688

Last Updated: 2024-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-26

Study Completion Date

2026-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Game group

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

Group Type EXPERIMENTAL

Mobile healthcare education game

Intervention Type 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.

Text group

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

Group Type PLACEBO_COMPARATOR

Mobile healthcare education application

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jung-Chen Chang, Phd

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Xin-Yi Lin

Role: CONTACT

886988619601

Facility Contacts

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XinYi Lin, Bs

Role: primary

+886988619601

Other Identifiers

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202312004RIND

Identifier Type: -

Identifier Source: org_study_id

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