UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019810 |
|---|---|
| Receipt number | R000022844 |
| Scientific Title | The Frequency of Extrapyramidal Symptoms In Cancer Patients Who Receive Palliative Care. A Multi-Center, Observational Study.(FRESH study) |
| Date of disclosure of the study information | 2015/11/16 |
| Last modified on | 2019/02/21 15:15:22 |
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Basic information
Public title
The Frequency of Extrapyramidal Symptoms In Cancer Patients Who Receive Palliative Care. A Multi-Center, Observational Study.(FRESH study)
Acronym
The Frequency of Extrapyramidal Symptoms In Cancer Patients Who Receive Palliative Care. A Multi-Center, Observational Study.(FRESH study)
Scientific Title
The Frequency of Extrapyramidal Symptoms In Cancer Patients Who Receive Palliative Care. A Multi-Center, Observational Study.(FRESH study)
Scientific Title:Acronym
The Frequency of Extrapyramidal Symptoms In Cancer Patients Who Receive Palliative Care. A Multi-Center, Observational Study.(FRESH study)
Region
| Japan |
Condition
Condition
Extrapyramidal Symptoms
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the frequency of extrapyramidal symptoms In cancer patients who receive palliative care.
Basic objectives2
Others
Basic objectives -Others
The frequency of extrapyramidal symptoms
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
DIEPSS
Key secondary outcomes
LUNSERS EPS subscale, CAM, drug utilization
Base
Study type
Observational
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who are planned to receive intervention by palliative care teams or to be hospitalized in palliative care units
2) Cancer patients who were informed of their diagnosis
3) Patients who are aged 20 years or older
Key exclusion criteria
Not specified
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroto Ishiki |
Organization
Research Hospital of the Institute of Medical Science, The University of Tokyo
Division name
Department of Palliative Medicine
Zip code
Address
4-6-1 Shirokanedai, Minato-ku, Tokyo 108-8639, Japan
TEL
03-3443-8111
ishiki-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroto Ishiki |
Organization
Research Hospital of the Institute of Medical Science, The University of Tokyo
Division name
Department of Palliative Medicine
Zip code
Address
4-6-1 Shirokanedai, Minato-ku, Tokyo 108-8639, Japan
TEL
03-3443-8111
Homepage URL
ishiki-tky@umin.ac.jp
Sponsor or person
Institute
Research Hospital of the Institute of Medical Science, The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
| 2015 | Year | 11 | Month | 16 | 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
| 2015 | Year | 11 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 16 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
- Prospective observational study
- Consecutive patients who visit the institutions and meet eligible criteria during one month after approval of institutional review board between Oct. 2015 and Sep. 2016.
- DIEPSS (Drug-induced extrapyramidal symptoms scale), LUNSERS (The Liverpool University Neuroleptic Side Effect Rating Scale), CAM (Confusion Assessment Method)
Management information
Registered date
| 2015 | Year | 11 | Month | 16 | Day |
Last modified on
| 2019 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022844
| 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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