UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019529
Receipt number R000022588
Scientific Title The effects of message framing on cervical cancer screening: a randomized controlled trial
Date of disclosure of the study information 2015/10/28
Last modified on 2015/11/02 09:26:13

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Basic information

Public title

The effects of message framing on cervical cancer screening: a randomized controlled trial

Acronym

EMCS trial

Scientific Title

The effects of message framing on cervical cancer screening: a randomized controlled trial

Scientific Title:Acronym

EMCS trial

Region

Japan


Condition

Condition

cervical cancer

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effect of providing information about screening via a printed reminder on cervical cancer screening rate at 4 months after intervention

Basic objectives2

Others

Basic objectives -Others

To evaluate the effect of printed reminder

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

cervical cancer screening rate

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

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

5

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

Receiving once a printed reminder with usual information.
Cervical cancer screening participation data within 4 months were compiled.

Interventions/Control_2

Receiving once a printed reminder with usual information and gain-framed message.
Cervical cancer screening participation data within 4 months were compiled.

Interventions/Control_3

Receiving once a printed reminder with usual information, benefit and risk.
Cervical cancer screening participation data within 4 months were compiled.

Interventions/Control_4

Receiving once a printed reminder with usual information and social norm message.
Cervical cancer screening participation data within 4 months were compiled.

Interventions/Control_5

Receiving once a printed reminder with usual information, benefit and loss-framed message.
Cervical cancer screening participation data within 4 months were compiled.

Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

39 years-old >=

Gender

Female

Key inclusion criteria

Women aged 20-39 years who had not participated in the screening in 2013 as non-adherent participants for this study

Key exclusion criteria

21, 26, 31 years old (free ticket holder)

Target sample size

3200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroyuki Fujiwara

Organization

Jichi Medical University

Division name

Department of Obstetrics and Gynecology

Zip code


Address

3311-1 Yakushiji, Shimotsuke, Tochigi 329-0498, Japan

TEL

0285-58-7376

Email

fujiwara@jichi.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroyuki Fujiwara

Organization

Jichi Medical University

Division name

Department of Obstetrics and Gynecology

Zip code


Address

3311-1 Yakushiji, Shimotsuke, Tochigi 329-0498, Japan

TEL

0285-58-7376

Homepage URL


Email

fujiwara@jichi.ac.jp


Sponsor or person

Institute

Department of Obstetrics and Gynecology, Jichi Medical University

Institute

Department

Personal name



Funding Source

Organization

MEXT KAKENHI

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


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

自治医科大学(栃木県)が主体となり、栃木県小山地区における集団検診を対象に行った


Other administrative information

Date of disclosure of the study information

2015 Year 10 Month 28 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed/25717376

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

2013 Year 11 Month 29 Day

Date of IRB


Anticipated trial start date

2013 Year 12 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 10 Month 28 Day

Last modified on

2015 Year 11 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022588


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name