UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034577
Receipt number R000039406
Scientific Title Intervention study on Cancer education- an approach to promote health among high school students
Date of disclosure of the study information 2018/10/22
Last modified on 2020/01/28 17:32:37

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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 or person

Institute

Hokkaido University

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039406


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name