UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030443 |
|---|---|
| Receipt number | 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 18:24:34 |
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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
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
hayano.biosignal.lab@gmail.com
Sponsor or person
Institute
Department of Medical Education
Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034759
