UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051097 |
|---|---|
| Receipt number | R000058270 |
| Scientific Title | An Examination of the effect of cancer education by using word-of-mouth: cervical cancer prevention program in Japan.-A study on the effect verification of the positive recommendation leaflet of cervical cancer prevention vaccine applying nudge theory-. |
| Date of disclosure of the study information | 2023/06/30 |
| Last modified on | 2023/05/18 13:58:22 |
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Basic information
Public title
A study on the effect verification of the positive recommendation leaflet of cervical cancer prevention vaccine applying nudge theory.
Acronym
cervical cancer prevention Leaflet intervention trial.
Scientific Title
An Examination of the effect of cancer education by using word-of-mouth: cervical cancer prevention program in Japan.-A study on the effect verification of the positive recommendation leaflet of cervical cancer prevention vaccine applying nudge theory-.
Scientific Title:Acronym
Regional Randomized Trial of Cervical Cancer Leaflet.
Region
| Japan |
Condition
Condition
cervical cancer
Classification by specialty
| Not applicable | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
At the beginning of the fiscal year, Osaka City sends a cervical cancer prevention leaflet to families of girls in the first year of junior high school along with information on individual cervical cancer vaccines (HPV vaccines). We are planning to enclose the same leaflet as last year in the 2023 individual vaccination guide, but the above 9-valent vaccine will be introduced as a routine vaccination from April 2023, and it will be the first individual vaccination recommendation guide.
This time, we will enclose either a regular leaflet (Leaflet B: no catchphrase) or a leaflet with a catchphrase created by our research group (Leaflet A: with a catchphrase) for the routine individual immunization information. increase. After shipping, we will compare and consider what kind of changes and effects can be seen in inoculation behavior.
The nudge theory was based on the model of Kochi City, Kochi Prefecture, where it was found that the recommendation message improved the health checkup rate of the residents. "Everyone cares, everyone acts" teaches us that people unconsciously live according to the social norms of the time and region, and how people in similar situations behave. It attempts a behavioral economics-validated model that can influence behavior by recommending individualized cervical cancer prevention vaccines.
The purpose of this research is to provide simple information that local governments want to convey to support the decision-making of those who are unsure about whether or not to receive the HPV vaccination. The aim was to verify the effectiveness of the original leaflet developed to provide information in an easy-to-understand manner, with the original slogan "Everyone is interested in the HPV vaccine as search terms are soaring!" and associated design.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
-The number of access/distribution of the QR code in the leaflet.
The basis for setting: Although the hard endpoint is the vaccination rate, estimating the number of vaccinations takes time. Therefore, the number of accesses/distribution of the QR code, one of the CV rates (Conversion Rate: number of achievements/total number of opportunities to see information) used in access analysis, which is a soft endpoint, is set as the primary evaluation item.
Key secondary outcomes
-HPV vaccination rate for first-year junior high school students in 2023
The rationale for setting: Although it is a hard endpoint, obtaining results takes more than one year.
-The number of accesses/distributions of QR codes adjusted by the Geographical Deprivation Index (ADI)
The rationale for setting: ADI is used to adjust for differences in vaccination coverage across districts.
ADI-adjusted HPV vaccination coverage
The odds ratio for HPV vaccination coverage in 7th grade in 2022 and 2023
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
A group that receives a leaflet with a catch phrase developed by the researcher.
Interventions/Control_2
A group that receives regular leaflets
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 13 | years-old | <= |
Age-upper limit
| 13 | years-old | >= |
Gender
Female
Key inclusion criteria
All female students who live in Osaka City will be in the first year of junior high school in 2023.
Key exclusion criteria
N/A
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Kayoko |
| Middle name | |
| Last name | Katayama |
Organization
Gunma University
Division name
Faculty of Informatics
Zip code
371-8510
Address
4-2 Aramaki-machi Maebashi-city Gunma.
TEL
0272207427
kkatayama11@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Kayoko |
| Middle name | |
| Last name | Katayama |
Organization
Gunma University
Division name
Faculty of Informatics
Zip code
371-8510
Address
4-2 Aramaki-machi Maebashi-city Gunma.
TEL
0272207427
Homepage URL
kkatayama11@gunma-u.ac.jp
Sponsor or person
Institute
Katayama Kayoko Cancer Prevention Research Team.
Institute
Department
Personal name
Funding Source
Organization
MSD
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
USA
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma University Medical Research Ethics Review Board for Human Subjects
Address
3-39-15 Showa-machi Maebashi city Gunma
Tel
027-220-8740
hitotaisho-ciru@ml.gunma-u.ac.jp
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
| 2023 | Year | 06 | Month | 30 | 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 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 05 | Month | 16 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 05 | Month | 18 | Day |
Last modified on
| 2023 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058270
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