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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000043603
Receipt No. R000049783
Scientific Title A feasibility study of game-based learning programs for childhood cancer survivors.
Date of disclosure of the study information 2021/03/12
Last modified on 2021/03/13

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Basic information
Public title A feasibility study of game-based learning programs for childhood cancer survivors.
Acronym A feasibility study of game-based learning programs for childhood cancer survivors.
Scientific Title A feasibility study of game-based learning programs for childhood cancer survivors.
Scientific Title:Acronym A feasibility 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
Email 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
Email masumoto.d@icloud.com

Sponsor
Institute Mie University Graduate School of Medicine
Institute
Department

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
Email 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
2021 Year 03 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049783

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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