UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Influence of evidence-based information and the usage of the term "mammography" on women's willingness to undergo mammography screening: randomized controlled trial
Title of the study (Brief title)	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
Condition	Adult
Classification by specialty	Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
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

Assessment
Primary outcomes	Willingness to undergo the screening with 0-10 Likert scale (at the time of survey)
Key secondary outcomes

Base
Study type	Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
Name of lead principal investigator	Junichiro Hayano
Organization	Nagoya City University
Division name	Department of Medical Education
Address	1 Kawasumi Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan
TEL	052-853-8499
Email	hayano.biosignal.lab@gmail.com

Public contact
Name of contact person	Yutaka Yoshida
Organization	Nagoya City University
Division name	Department of Medical Education
Address	1 Kawasumi Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan
TEL	052-853-8499
Homepage URL
Email	hayano.biosignal.lab@gmail.com

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

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2017 Year 12 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 12 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
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.
Other related information

Management information
Registered date	2017 Year 12 Month 18 Day
Last modified on	2018 Year 09 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034759