EGFR Gene MutationNCT06291688
Applying Mobile Healthcare Education to Improve Cutaneous Self-care Capability
A study testing Mobile healthcare education game and Mobile healthcare education application in people with EGFR Gene Mutation and Drug-Related Side Effects and Adverse Reactions, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- EGFR Gene Mutation, Drug-Related Side Effects and Adverse Reactions, Cancer, Treatment-Related
- What is being tested?
- Mobile healthcare education game and Mobile healthcare education application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Jan 2024to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults whose age is above 18.
- Patients are receiving EGFR-base target drugs now.
- Patients can use smart phone.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100225
XinYi Lin, Bs, +886988619601, r11426019@ntu.edu.tw
About this study
Official title: 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
Read more
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.
Read the 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.
- Conditions
- EGFR Gene Mutation, Drug-Related Side Effects and Adverse Reactions, Cancer, Treatment-Related, Cancer
- Being tested
- Mobile healthcare education game, Mobile healthcare education application
- Keywords
- Mobile Healthcare education, Game-based learning, Self-care capability, Learning motivation, Quality of life
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions, Neoplasms, Second Primary, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile healthcare education gameBehavioural
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.
Mobile healthcare education applicationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Game group | Experimental | An educational game regarding common EGFR-related cutaneous adverse drug reactions on a mobile APP Receives: Behavioral: Mobile healthcare education game |
| Text group | Placebo comparator | An educational text regarding common EGFR-related cutaneous adverse drug reactions on a mobile APP Receives: Behavioral: Mobile healthcare education application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1, Day 15, Day 30
Secondary outcomes (4)
Investigate the learning motivation towards CADR by self-designed questionnaire at Day 15
Compare learning motivations between different groups towards CADR
Measured: 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
Measured: 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.
Measured: 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
Measured: Day1, Day15, Day30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start26 Jan 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EGFR Gene MutationStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jung-Chen Chang, Phd, Principal investigator, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06291688
- Sponsor's protocol ID
- 202312004RIND
- Status last verified
- Feb 2024
- First submitted
- 5 Feb 2024
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Applying Mobile Healthcare Education to Improve Cutaneous Self-care Capability for Patients Receiving Targeted Therapy
- ClinicalTrials.gov ID
- NCT06291688
- Acronym / sponsor ID
- 202312004RIND
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 26 Jan 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Game group | Experimental | Behavioral: Mobile healthcare education gameAn educational game regarding common EGFR-related cutaneous adverse drug reactions on a mobile APP |
| Text group | Placebo comparator | Behavioral: Mobile healthcare education applicationAn educational text regarding common EGFR-related cutaneous adverse drug reactions on a mobile APP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults whose age is above 18.
- Patients are receiving EGFR-base target drugs now.
- Patients can use smart phone.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile healthcare education gameGame 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. | Behavioural | Game group |
| Mobile healthcare education applicationText group will download an APP on a smart phone and open the APP to see the text regarding EGFR-related cutaneous adverse drug reactions. | Behavioural | Text group |
Primary outcome
Change from baseline in the score of cutaneous adverse drug reaction (CADR) knowledge on researcher-designed questionnaire at Day 15 and Day 30.
Time frame: Day 1, Day 15, Day 30
Comparing the improvement of CADR knowledge between different groups
4 secondary outcomes
Investigate the learning motivation towards CADR by self-designed questionnaire at Day 15
Time frame: Day 15
Change from baseline in the score of the quality of life on DLQI questionnaire at Day 15 and Day 30
Time frame: Day 1, Day15, Day 30
Investigate the user-experience of the mobile healthcare education APP by researcher-designed questionnaire at Day 15.
Time frame: Day 15
Change from baseline in the score of the self-care measurement adherence on researcher-designed questionnaire at Day 15 and Day30.
Time frame: Day1, Day15, Day30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jung-Chen Chang, Phd principal investigator
National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile healthcare education game and Mobile healthcare education application in people with EGFR Gene Mutation and Drug-Related Side Effects and Adverse Reactions, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xin-Yi Lin (886988619601, r11426019@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the score of cutaneous adverse drug reaction (CADR) knowledge on researcher-designed questionnaire at Day 15 and Day 30. (time frame: Day 1, Day 15, Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.