UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029052 |
|---|---|
| Receipt number | R000033229 |
| Scientific Title | Predictive factors for psychological distress related to treat esophageal cancer |
| Date of disclosure of the study information | 2017/09/08 |
| Last modified on | 2017/09/08 10:53:41 |
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Basic information
Public title
Predictive factors for psychological distress related to treat esophageal cancer
Acronym
Predictive factors for psychological distress related to treat esophageal cancer
Scientific Title
Predictive factors for psychological distress related to treat esophageal cancer
Scientific Title:Acronym
Predictive factors for psychological distress related to treat esophageal cancer
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The evaluation of the psychological distress and QOL related to treat esophageal cancer
Basic objectives2
Others
Basic objectives -Others
Predictive factors for psychological distress related to treat esophageal cancer
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
psychological distress
1. HADS: Hospital anxiety and depression scale
2. EORTC QLQ-C30/ OES18: European Organization for Research and Treatment of Cancer QLQ C-30/ OES18
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Esophageal cancer patients underwent esophagectomy
2. Pt. aged 20 to 85 years
3. Performance status 0-2
4. Written informed consent
5. Pt. with notification of their cancer disease
Key exclusion criteria
1. No informed consent is obtained
2. Pt. with a history of severe cognitive impairment and mental disorder
3. Pt. who have judged by doctor or nurse not to be suitable for this study participation because of psycological and physical stress.
4. Pt. who have judged by doctor or nurse not to be suitable for this study participation
5. Pt. didn't hope for an operation
6. Pt. without esophagectomy
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eisuke Matsushima |
Organization
Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental
University
Division name
Section Division of Liaison Psychiatry and Palliative Medicine
Zip code
Address
1-5-45, yushima, bunkyo-ku, tokyo
TEL
03-3803-5859
em.lppm@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yu Ohkura |
Organization
Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental
Division name
Section Division of Liaison Psychiatry and Palliative Medicine
Zip code
Address
1-5-45, yushima, bunkyo-ku, tokyo
TEL
03-3803-5859
Homepage URL
yu.ohkura107@gmail.com
Sponsor or person
Institute
Toranomon Hospital
Institute
Department
Personal name
Funding Source
Organization
Toranomon Hospital
Organization
Division
Category of Funding Organization
Other
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
| 2017 | Year | 09 | Month | 08 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 04 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2017 | Year | 09 | Month | 08 | Day |
Last modified on
| 2017 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033229
| 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 |
