![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
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 |
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 |
|
Condition | ||
Condition | Spiritual pain | |
Classification by specialty |
|
|
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 |
|
||
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 |
|
|||
Age-upper limit |
|
|||
Gender | Male and Female | |||
Key inclusion criteria | Doctor | |||
Key exclusion criteria | Non | |||
Target sample size | 30 |
Research contact person | |||||||
Name of lead principal investigator |
|
||||||
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 |
|
||||||
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 | |
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 | |
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 |
|
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 |
|
||||||
Date of IRB | |||||||
Anticipated trial start date |
|
||||||
Last follow-up date |
|
||||||
Date of closure to data entry |
|
||||||
Date trial data considered complete |
|
||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
|
||||||
Last modified on |
|
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 |