UMIN-CTR Clinical Trial

Basic information
Public title	Development of an intervention program to enhance "self-confidence in answering questions when asked" for professionals who consult or disseminate information about radiation-related health concerns examination of its feasibility
Acronym	Development of an intervention program to enhance "self-confidence in answering questions when asked" for professionals who consult or disseminate information about radiation-related health concerns examination of its feasibility
Scientific Title	Feasibility study of an intervention program to enhance self-confidence of professionals who deal with radiation-related health concerns
Scientific Title:Acronym	Feasibility study of an intervention program to enhance self-confidence of professionals who deal with radiation-related health concerns
Region	Japan

Condition
Condition	Healthy Adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the feasibility of a "literacy enhancement program" targeting professionals that frequently receive consultations about radiation health concerns.
Basic objectives2	Others
Basic objectives -Others	Feasibility
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Feasibility Impressions of the program (whether it was easy to participate in the program and participants recommend attendance to others.)
Key secondary outcomes	Radiation-related knowledge Literacy

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	Lecture 50minutes Group Discussion 40minutes Presentation 10minutes
Interventions/Control_2	Provision of materials
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	N/A
Key exclusion criteria	N/A
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Seiji Middle name Last name Yasumura
Organization	Fukushima Medical University
Division name	Department of Public Health
Zip code	960-1295
Address	1, Hikarigaoka, Fukushima
TEL	024-547-1180
Email	yasumura@fmu.ac.jp

Public contact
Name of contact person	1st name Seiji Middle name Last name Yasumura
Organization	Fukushima Medical University
Division name	Department of Public Health
Zip code	9601295
Address	1, Hikarigaoka, Fukushima
TEL	0245471180
Homepage URL
Email	yasumura@fmu.ac.jp

Sponsor
Institute	Fukushima Medical University
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Fukushima Medical University
Address	1, Hikarigaoka, Fukushima
Tel	0245471825
Email	rs@fmu.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	2020 Year 11 Month 25 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	25
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	No longer recruiting
Date of protocol fixation	2020 Year 10 Month 23 Day
Date of IRB	2020 Year 11 Month 17 Day
Anticipated trial start date	2020 Year 11 Month 25 Day
Last follow-up date	2021 Year 01 Month 31 Day
Date of closure to data entry	2021 Year 02 Month 04 Day
Date trial data considered complete	2021 Year 04 Month 07 Day
Date analysis concluded	2021 Year 04 Month 07 Day

Other
Other related information

Management information
Registered date	2020 Year 11 Month 24 Day
Last modified on	2021 Year 05 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048144