UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009578 |
|---|---|
| Receipt number | R000010815 |
| Scientific Title | Effect of print reminder on colorectal cancer screening in a community setting: A randomized controlled study |
| Date of disclosure of the study information | 2012/12/20 |
| Last modified on | 2016/02/09 14:30:21 |
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Basic information
Public title
Effect of print reminder on colorectal cancer screening in a community setting: A randomized controlled study
Acronym
Print reminder on colorectal cancer screening
Scientific Title
Effect of print reminder on colorectal cancer screening in a community setting: A randomized controlled study
Scientific Title:Acronym
Print reminder on colorectal cancer screening
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effect of print reminder on uptake of colorectal cancer screening among general population.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Colorectal Cancer screening rate
Key secondary outcomes
Knowledge and attitude on Colorectal cancer and Colorectal cancer screening
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
In the intervention group 1, the printed reminder is mailed to the participants' house from local government in December, 2012, in order to inform (a)they are due for screening, (b) morbidity of colorectal cancer, (c) 5-year survival rate by stage, (d) screening procedure.
Interventions/Control_2
In the intervention group 2, the printed reminder is mailed to the participants' house from local government in December, 2012, in order to inform (a) they are due for screening, (b) morbidity of colorectal cancer, (c) 5-year survival rate by stage, (d) screening procedure, (e) importance of repeated screening, (f) positive predictive value of colorectal cancer screening.
Interventions/Control_3
Although no reminder is delivered to the control group, control group is exposed to routine publicity campaigns that inform the residents about the colorectal cancer screening program by the local government through its website and monthly government newsletter.
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
| 40 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The individuals selected for inclusion in the study meet the following criteria: (a) registered in the population registry of the local government as of October 2012; and (b) 46-69 years old.
Key exclusion criteria
The excluded individuals in the study meet the following criteria: (a) those who receive free coupon provided by the local government; and (b) no recorded FOBT in the previous 7 months.
Target sample size
4500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Saito |
Organization
National Cancer Center
Division name
Screening Assessment & Management Division
Zip code
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan
TEL
03-3542-2511
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Saito |
Organization
National Cancer Center
Division name
Screening Assessment & Management Division
Zip code
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan
TEL
03-3542-2511
Homepage URL
http://canscreen.ncc.go.jp/management/index.html
crc-manual@ml.res.ncc.go.jp
Sponsor or person
Institute
Screening Assessment & Management Division, National Cancer Center
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
Name of secondary funder(s)
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
八王子市（東京都）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 20 | Day |
Related information
URL releasing protocol
http://canscreen.ncc.go.jp/management/index.html
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Out of 1,156 respondents, 81 (7.0%) participated in colorectal cancer screening. 67 participants (9.7%) in the intervention groups participated in colorectal cancer screening, whereas only 14 (3.0%) of the control group participated in screening (p < 0.001). In addition, logistic regression analysis revealed that 28 (7.3%) of intervention group 1 revealed statistically-significant attendance over control group (OR=2.54, p=0.005). Also, 39 (12.5%) of intervention group 2 revealed statistically-significant attendance over control group (OR=4.59, p<0.001). Furthermore, there was significant difference in screening attendance between control group 1 and control group 2 (OR=1.81, p=0.029).
With respect to recipients of the intervention groups were much more likely to have good knowledge than were recipients of the control group (p<0.001). On the other hand, there was no significant difference in attitude between the groups (p=0.294).
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
| 2012 | Year | 10 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2013 | Year | 08 | Month | 30 | Day |
Date analysis concluded
| 2013 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 18 | Day |
Last modified on
| 2016 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010815
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