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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030443
Receipt No. R000034759
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
Date of disclosure of the study information 2017/12/18
Last modified on 2018/09/20

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Basic information
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
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
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

Public contact
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

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)

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

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 18 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: 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

Progress
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
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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