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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001613
Receipt No. R000001938
Scientific Title Meaninglessness in terminally ill cancer patients: Doctor Education Intervention Trial
Date of disclosure of the study information 2009/01/02
Last modified on 2009/12/22

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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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