UMIN-CTR Clinical Trial

Basic information
Public title	Meaninglessness in terminally ill cancer patients: Doctor Education Intervention Trial
Acronym	Meaninglessness in terminally ill cancer patients: Doctor Education Intervention Trial
Scientific Title	Meaninglessness in terminally ill cancer patients: Doctor Education Intervention Trial
Scientific Title:Acronym	Meaninglessness in terminally ill cancer patients: Doctor Education Intervention Trial
Region	Japan

Condition
Condition	Spiritual pain
Classification by specialty	Not applicable
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Few studies have reported the effects of training programs for doctors specifically aimed at improving skills to relieve meaninglessness in terminally ill cancer patients. The primary aims of this intervention trial were to determine the effects of an educational workshop focusing on patients` feelings of meaninglessness on doctors` confidence, self-reported practice, attitudes toward caring for such patients, in addition to burnout, and meaning of life.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Confidence and Self-reported practice scales, and the Attitudes toward caring for patients feeling meaningless scale (Willingness to help, Positive appraisal, and Helplessness), Maslach burnout scale
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -but assessor(s) are blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom Maneuver
Interventions/Control_1	Three 240-minute sessions over 7 weeks, including lectures and exercises using structured assessment
Interventions/Control_2
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	24 years-old <=
Age-upper limit	60 years-old >=
Gender	Male and Female
Key inclusion criteria	Doctor
Key exclusion criteria	Non
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yasunori Matoba, M.D., PhD.
Organization	Kagoshima University Graduate School of Medical and Dental Sciences
Division name	Department of surgical oncology and digestive surgery
Zip code
Address	8-35-1Sakuragaoka, kagoshima, kagoshima
TEL	099-275-5361
Email

Public contact
Name of contact person	1st name Middle name Last name Yasunori Matoba, M.D., PhD.
Organization	Kagoshima University Graduate School of Medical and Dental Sciences
Division name	Department of surgical oncology and digestive surgery
Zip code
Address	8-35-1Sakuragaoka, kagoshima, kagoshima
TEL	099-275-5361
Homepage URL
Email	matoba@m3.kufm.kagoshima-u.ac.jp

Sponsor
Institute	Yasunori Matoba, M.D., PhD.
Institute
Department

Funding Source
Organization	Yasunori Matoba, M.D., PhD.
Organization
Division
Category of Funding Organization	Self funding
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	2009 Year 01 Month 02 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	2007 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date	2007 Year 06 Month 01 Day
Last follow-up date	2010 Year 03 Month 01 Day
Date of closure to data entry	2010 Year 03 Month 01 Day
Date trial data considered complete	2010 Year 03 Month 01 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2009 Year 01 Month 02 Day
Last modified on	2009 Year 12 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001938

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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