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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004384
Receipt No. R000005238
Scientific Title Community intervention study about Cancer screening behavior of Colorectal cancer
Date of disclosure of the study information 2011/03/31
Last modified on 2011/04/19

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Basic information
Public title Community intervention study about Cancer screening behavior of Colorectal cancer
Acronym Community intervention study about Cancer screening behavior of Colorectal cancer
Scientific Title Community intervention study about Cancer screening behavior of Colorectal cancer
Scientific Title:Acronym Community intervention study about Cancer screening behavior of Colorectal cancer
Region
Japan

Condition
Condition Colorectal cancer
Classification by specialty
Not applicable
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To examinie whether tailored intervention that was based on trans-theorical model (TTM) promote more participation rate in colorectal cancer screening for communitiy residents than usual intervention
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes participation rate in colorectal cancer screening
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Tailored-Matched group:
Stage of colorectal cancer screening behavior based on TTM model in each participants were assessed, they are shown the tailored message that matches their stage.
Interventions/Control_2 Tailored-Nonmatched group:
Stage of colorectal cancer screening behavior based on TTM model in each participants were assessed, they are shown the message that, although we use same messages as Tailored-Matched group, does not matches their stages.
Interventions/Control_3 Common message group:
Participants were uniformly shown the single message that was developed with a social marketing approach. This message was conposed of the common element to three messages
Interventions/Control_4 Control group:
Participants were uniformly shown the message of cancer screening that arbitrary local government uses
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
60 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria 1. Community residents over 60 and less than 65 years old and living in Onomiti City
2. people taked out the national health insurance
3. people returned survey form that included request of this research
4. people not received a colorectal cancer screening within the last 1 year
Key exclusion criteria 1. people received a colorectal cancer screening within the last 1 year
Target sample size 2560

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Daisuke Shibuya
Organization Miyagi Cancer Society
Division name Center of cancer screening
Zip code
Address Uesugi5-7-30, Aoba-ku, Sendai City, 980-0011 Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kei Hirai
Organization Graduate School of Medicine, Faculty of Medicine, Osaka University
Division name Department of Complementalry and Alternative Medicine
Zip code
Address Yamadaoka 2-2, Suita City, 565-0871, JAPAN
TEL
Homepage URL
Email

Sponsor
Institute Miyagi Cancer Society
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization JAPAN

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2011 Year 03 Month 31 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
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
2010 Year 10 Month 06 Day
Date of IRB
Anticipated trial start date
2010 Year 11 Month 01 Day
Last follow-up date
2011 Year 03 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
2010 Year 10 Month 14 Day
Last modified on
2011 Year 04 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005238

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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