UMIN-CTR Clinical Trial

Basic information
Public title	An open-label randomized trial of web-based educational program for diagnostic capability of skin tumor
Acronym	A randomized trial of educational program for diagnostic capability of skin tumor
Scientific Title	An open-label randomized trial of web-based educational program for diagnostic capability of skin tumor
Scientific Title:Acronym	A randomized trial of educational program for diagnostic capability of skin tumor
Region	Japan

Condition
Condition	skin tumor
Classification by specialty	Medicine in general Dermatology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effectiveness of web-based educational program with self-learning materials on diagnostic capability of skin tumor
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Scores of self-administered questionnaires about definitive diagnosis of skin tumor
Key secondary outcomes	Scores of self-administered questionnaires about differentiating skin cancer

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Educational program group= Web-based educational program with self-learning materials+ ordinary learning with own sources
Interventions/Control_2	Control group= Ordinary learning with own sources
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Medical doctors mainly engaging general or family practice. 2. Medical doctors fluent in Japanese.
Key exclusion criteria	1. Medical doctors mainly engaging dermatological practice. 2. Medical doctors working less than three days a week.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yosuke Yamamoto
Organization	Graduate School of Medicine, Kyoto University
Division name	Department of Epidemiology and Healthcare Research
Zip code
Address	Yoshida Konoe-cho, Sakyo-ku, Kyoto, Japan
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name
Organization	Graduate School of Medicine, Kyoto University
Division name	Department of Epidemiology and Healthcare Research
Zip code
Address	Yoshida Konoe-cho, Sakyo-ku, Kyoto, Japan
TEL
Homepage URL
Email

Sponsor
Institute	Department of Epidemiology and Healthcare Research, Graduate School of Medicine, Kyoto University
Institute
Department

Funding Source
Organization	Japan Ministry of Health, Labor, and Welfare
Organization
Division
Category of Funding Organization
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	2008 Year 12 Month 31 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	Terminated
Date of protocol fixation	2008 Year 10 Month 03 Day
Date of IRB
Anticipated trial start date	2009 Year 01 Month 01 Day
Last follow-up date	2010 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2008 Year 12 Month 24 Day
Last modified on	2009 Year 12 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001915

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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