UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004384 |
|---|---|
| Receipt number | 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 10:51:36 |
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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
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
Sponsor or person
Institute
Miyagi Cancer Society
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005238
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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