UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024811 |
|---|---|
| Receipt number | R000028553 |
| Scientific Title | An interventional study to examine the effect of shared decision making in a family on intention of HPV vaccination in order to protect Japanese girls from HPV due to the low coverage of the vaccination and excess of mothers' responsibility to make a decision. |
| Date of disclosure of the study information | 2016/11/12 |
| Last modified on | 2019/05/08 20:31:28 |
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Basic information
Public title
An interventional study to examine the effect of shared decision making in a family on intention of HPV vaccination in order to protect Japanese girls from HPV due to the low coverage of the vaccination and excess of mothers' responsibility to make a decision.
Acronym
Shared decision making in a family on intention of HPV vaccination
Scientific Title
An interventional study to examine the effect of shared decision making in a family on intention of HPV vaccination in order to protect Japanese girls from HPV due to the low coverage of the vaccination and excess of mothers' responsibility to make a decision.
Scientific Title:Acronym
Shared decision making in a family on intention of HPV vaccination
Region
| Japan |
Condition
Condition
Cervical cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of the study is to examine the effect of shared decision making in a family with decision aids on improvement in intention of the HPV vaccination.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intention to vaccinate young females
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
The one group will be instructed to involve their husband in the discussion with newly created decision aid materials as well as the promotional leaflet. These materials and the questionnaire will be delivered by mail.
Interventions/Control_2
The control group of people will be mailed with only leaflet of vaccination promotion.
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
| 12 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Female
Key inclusion criteria
The target population is married mothers whose daughters must be from 12 to 18 years old.
Key exclusion criteria
The criteria of exclusion into the study is that their daughters have already had experience of HPV vaccination.
Target sample size
900
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tadashi Kimura |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
Address
2-2 Yamadaoka, Suita
TEL
06-6879-3351
tadashi@gyne.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yusuke Tanaka |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
Address
2-2 Yamadaoka, Suita
TEL
06-6879-3351
Homepage URL
ytanaka-jun@umin.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Investigator Studies Program by Merck & Co.
Organization
Division
Category of Funding Organization
Other
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
| 2016 | Year | 11 | Month | 12 | 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
Completed
Date of protocol fixation
| 2016 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 14 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 21 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 12 | Day |
Last modified on
| 2019 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028553
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| Registered date | File name |
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| Registered date | File name |
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