UMIN-CTR Clinical Trial

Public title

Influence of evidence-based information and the usage of the term "mammography" on women's willingness to undergo mammography screening: randomized controlled trial

Acronym

Influence of evidence-based information and the usage of the term "mammography" on women's willingness to undergo mammography screening: randomized controlled trial

Scientific Title

Influence of evidence-based information and the usage of the term "mammography" on women's willingness to undergo mammography screening: randomized controlled trial

Scientific Title:Acronym

Influence of evidence-based information and the usage of the term "mammography" on women's willingness to undergo mammography screening: randomized controlled trial

Region

Japan

Condition

Adult

Classification by specialty

Adult

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate how well-informed decision can be achieved

Basic objectives2

Others

Basic objectives -Others

To evaluate the influence of evidence-based information and the usage of the term "mammography" on women's willingness to undergo mammography screening

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Willingness to undergo the screening with 0-10 Likert scale (at the time of survey)

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Blocking

NO

Concealment

Pseudo-randomization

No. of arms

4

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

Survey (Information from the mammography screening promotion leaflet with the term "mammography screening")

Interventions/Control_2

Survey (Information from the mammography screening promotion leaflet without the term "mammography screening")

Interventions/Control_3

Survey (Evidence-based information with the term "mammography screening")

Interventions/Control_4

Survey (Evidence-based information without the term "mammography screening")

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

30

years-old

<=

Age-upper limit

120

years-old

>

Gender

Female

Key inclusion criteria

Women over 30

Key exclusion criteria

None

Target sample size

300

Name of lead principal investigator

1st name
Middle name
Last name	Junichiro Hayano

Organization

Nagoya City University

Division name

Department of Medical Education

Zip code

Address

1 Kawasumi Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan

TEL

052-853-8499

Email

hayano.biosignal.lab@gmail.com

Name of contact person

1st name
Middle name
Last name	Yutaka Yoshida

Organization

Nagoya City University

Division name

Department of Medical Education

Zip code

Address

1 Kawasumi Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan

TEL

052-853-8499

Homepage URL

Email

hayano.biosignal.lab@gmail.com

Institute

Department of Medical Education
Nagoya City University Graduate School of Medical Sciences

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

12

Month

18

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results: Between Dec 19, 2017, and Dec 20, 2017, we assigned 330 women to promotional sentences with "mammography" (n=88; Willingness to undergo the esamination 7.3; SD 3.0), evidence-based information with "mammography" (n=80; 7.4; SD 2.8), promotional sentences with "A" (n=90; 7.5; SD 2.3), or evidence-based sentences with "A" (n=72; 6.3; SD 2.4). The interaction between the type of sentences and the use of the term "mammography" was statistically significant (Generalized linear model p=0.02). When the alphabet "A" was used, mammography campaign's sentences increased women's willingness to undergo the examination compared with the evidence-based information (Cohen's d=0.56. 95% CI; 0.24 to 0.87. T-test; p<0.001), but not among the groups where the term "mammography" was used (p=0.87). When the evidence-based information was presented, the term "mammography" motivated women more than the alphabet "A" (Cohen's d=0.43; 95% confidence interval; 0.12 to 0.75; T-test p<0.01), while there was no significant difference among the groups where the promotional descriptions were used (p=0.32). Conclusions: Not only the sentences used in mammography screening campaigns but also the use of the term "mammography" itself could make women more willing to undergo the examination.

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

Recruitment status

Completed

Date of protocol fixation

2017

Year

12

Month

17

Day

Date of IRB

Anticipated trial start date

2017

Year

12

Month

18

Day

Last follow-up date

2017

Year

12

Month

20

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

12

Month

18

Day

Last modified on

2018

Year

09

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034759