UMIN-CTR Clinical Trial

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	Obsterics 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
Last 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
Email	tadashi@gyne.med.osaka-u.ac.jp

Public contact
1st 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
Email	ytanaka-jun@umin.ac.jp

Sponsor
Institute	Osaka University Graduate School of Medicine
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028553