UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043603 |
|---|---|
| Receipt number | R000049783 |
| Scientific Title | A pilot study of game-based learning programs for childhood cancer survivors |
| Date of disclosure of the study information | 2021/03/12 |
| Last modified on | 2022/03/11 19:49:04 |
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Basic information
Public title
A pilot study of game-based learning programs for childhood cancer survivors
Acronym
A pilot study of game-based learning programs for childhood cancer survivors
Scientific Title
A pilot study of game-based learning programs for childhood cancer survivors
Scientific Title:Acronym
A pilot study of game-based learning programs for childhood cancer survivors
Region
| Japan |
Condition
Condition
Childhood cancer
Classification by specialty
| Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In this study, we developed game-based learning programs, where a patient can play a computer game with stories along the player's cancer diagnosis and treatment. Then, we assessed feasibility of the programs before introducing this new modality of patient education to survivorship care.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
CCSs over 10 years of age are enrolled into this study. Two types of computer games were developed for education to children or adolescents and young adults. The study participants are evaluated for their health management awareness, self-esteem and knowledge on cancer-related late effects before and after the educational interventions (Baseline, 1 month, 6 months, 12 months). Age-based questionnaires and knowledge tests are used for the evaluation.
We use three scales for assessment of health management awareness, School-Life Skill scale for elementary school children and junior high school students and a Japanese version of the perceived health competence scale for adolescents and young adults ( AYA ).
For assessment of self-esteem, we use the Japanese version of the perceived competence scale for school children and the Japanese version of Rosenberg's self-esteem scale for AYA.
For assessment of knowledge level, we produced knowledge tests for school children and AYA.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
CCSs giving their consents to the participation are enrolled into the study.
They are assessed for their baseline health-management awareness, self-esteem and knowledge on late effects among CCSs before educational interventions. After the baseline assessment, they are given instructions on game operation by an investigator of this study.
The participant is lent a tablet-type device or a laptop computer where the game was installed, and requested to play the game for one month at home. The device is taken back at the end of one-month play. Their post-educational health-management awareness, self-esteem and knowledge gained from the game-based educations are surveyed at 1, 6 and 12-month from the baseline assessment.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 10 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Childhood cancer survivors aged over 10 years who regularly visit the Long Term Follow Up clinic at Mie university hospital, Mie, Japan.
The survivors who were informed of their diagnoses at onset of their cancer.
Key exclusion criteria
CCSs with severely impaired cognitive function, psychiatric disorder or developmental disorder are excluded.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Hori |
Organization
Mie University Graduate School of Medicine
Division name
Department of Medical Education
Zip code
514-8507
Address
2-174, Edobashi, Tsu, Mie
TEL
059-231-6003
hhori@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Masumoto |
Organization
Mie University Graduate School of Medicine
Division name
Department of Medical Education
Zip code
514-8507
Address
2-174, Edobashi, Tsu, Mie
TEL
059-231-6003
Homepage URL
masumoto.d@icloud.com
Sponsor or person
Institute
Mie University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
HAYAO NAKAYAMA Foundation for Science & Technology and Culture
Certified NPO corporation Heart Link Working Project
IRB Contact (For public release)
Organization
Mie University Hospital
Address
2-174, Edobashi, Tsu, Mie
Tel
059-231-5246
kk-sien@med.mie-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 03 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
83
Results
Among 83 participants, 49 (59.0%) completed the assessments over the period of 12 months. Health management awareness and knowledge increased significantly after the intervention. The effect was maintained for 12 months in school children while it decreased in AYA with time. Self-esteem significantly elevated at 1-month and continued for 12 months in both age groups.
Results date posted
| 2021 | Year | 03 | Month | 12 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
After the survey, it took longer than expected for statistical analysis and manuscript preparation, so the publication of the results was delayed.
In addition, the report was delayed due to reconsideration in the process of submission to academic journals.
Date of the first journal publication of results
Baseline Characteristics
As planed.
Participant flow
As planed.
Adverse events
None.
Outcome measures
As planed.
Plan to share IPD
None.
IPD sharing Plan description
None.
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 07 | Month | 22 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 03 | Month | 12 | Day |
Last modified on
| 2022 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049783
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