UMIN-CTR Clinical Trial

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
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	2022 Year 03 Month 11 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049783