UMIN-CTR Clinical Trial

Basic information
Public title	Intervention study on Cancer education- an approach to promote health among high school students
Acronym	Intervention study on Cancer education- an approach to promote health among high school students
Scientific Title	Intervention study on Cancer education- an approach to promote health among high school students
Scientific Title:Acronym	Intervention study on Cancer education- an approach to promote health among high school students
Region	Asia(except Japan)

Condition
Condition	High school students
Classification by specialty	Nursing Adult Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The general purpose of this study is to develop and evaluate the effectiveness of a cancer education program for high school students using Learning partner model.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	knowledge retention about cancer
Key secondary outcomes	initiation of healthy behaviors

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	cancer education program and group discussion
Interventions/Control_2	The assignment will include a few questions related to cancer prevention and screening
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	15 years-old <=
Age-upper limit	19 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Senior high school students studying in their respective school 2. Students whose parents approved their children to participate in the study 3. Those who are present during the survey. 4. Students who are physically and mentally sound. 5. Mothers or family members of high school students who take part in this study
Key exclusion criteria	Students whose parents don't approved their children to participate in the study
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Naomi Middle name Last name Sumi
Organization	Hokkaido University
Division name	Faculty of Health Sciences
Zip code	060-0812
Address	Kita12, Nishi5, Kitaku
TEL	011-706-3697
Email	nsumi@hs.hokudai.ac.jp

Public contact
Name of contact person	1st name Naomi Middle name Last name Sumi
Organization	Hokkaido University
Division name	Faculty of Health Sciences
Zip code	060-0812
Address	Kita12, Nishi5, Kitaku
TEL	011-706-3697
Homepage URL
Email	nsumi@hs.hokudai.ac.jp

Sponsor
Institute	Hokkaido University
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	hokkaido University
Address	Kita12, Nishi5, Kitaku, Sapporo
Tel	011-706-3316
Email	syomu@hs.hokudai.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	2018 Year 10 Month 22 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	626
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 10 Month 01 Day
Date of IRB	2018 Year 02 Month 19 Day
Anticipated trial start date	2019 Year 04 Month 10 Day
Last follow-up date	2019 Year 11 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 10 Month 19 Day
Last modified on	2020 Year 01 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039406