UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001613 |
|---|---|
| Receipt number | 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 22:28:28 |
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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
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
matoba@m3.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Yasunori Matoba, M.D., PhD.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001938
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
