UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008170
Receipt number R000009596
Scientific Title The effect of printed reminders on the use of colorectal cancer screening follow-up exams: A randomized controlled study
Date of disclosure of the study information 2012/06/14
Last modified on 2014/09/16 15:56:55

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Basic information

Public title

The effect of printed reminders on the use of colorectal cancer screening follow-up exams: A randomized controlled study

Acronym

effect of printed reminders for colorectal cancer screening follow-up exam

Scientific Title

The effect of printed reminders on the use of colorectal cancer screening follow-up exams: A randomized controlled study

Scientific Title:Acronym

effect of printed reminders for colorectal cancer screening follow-up exam

Region

Japan


Condition

Condition

Healthy Adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study examined the effectiveness of mailing printed reminders to encourage follow-up exam of colorectal cancer screening use.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Rate of colorectal cancer screening follow-up exams

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Single blind -participants are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

Participants in the intervention group receive print reminders from physician. In the print reminders, information on the benefits of getting colorectal cancer screening, incident and mortality of colorectal cancer screening, lists of screening facilities are described.

Interventions/Control_2

Usual Care

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

40 years-old <

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Those who participate in colorectal cancer screening between May, 2012 and March, 2013 and visit physicians to get screening results.

Key exclusion criteria

Those who participate in colorectal cancer screening between May, 2012 and March, 2013 and do not visit physicians to get screening results.

Target sample size

1000


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, 104-0045, Japan

TEL

03-3542-2511

Email

hrsaito@ncc.go.jp


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, 104-0045, Japan

TEL

03-3542-2511

Homepage URL


Email

hrsaito@ncc.go.jp


Sponsor or person

Institute

Screening Assessment & Management Division, National Cancer Center

Institute

Department

Personal name



Funding Source

Organization

Grant for the Third-Term Comprehensive 10-year Strategy for Cancer Control from the Ministry of Health, Labour and Welfere of Japan

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Omiya Medical Association

Name of secondary funder(s)



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

大宮医師会(埼玉県)


Other administrative information

Date of disclosure of the study information

2012 Year 06 Month 14 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

2012 Year 04 Month 20 Day

Date of IRB


Anticipated trial start date

2012 Year 05 Month 01 Day

Last follow-up date

2014 Year 09 Month 01 Day

Date of closure to data entry

2014 Year 09 Month 01 Day

Date trial data considered complete

2014 Year 09 Month 30 Day

Date analysis concluded

2014 Year 09 Month 30 Day


Other

Other related information



Management information

Registered date

2012 Year 06 Month 14 Day

Last modified on

2014 Year 09 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009596


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name