UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049993 |
|---|---|
| Receipt number | R000056939 |
| Scientific Title | Long-Term Effects of Occupation-Based Intervention for Patients with Brain Tumors |
| Date of disclosure of the study information | 2023/01/15 |
| Last modified on | 2023/02/26 19:11:25 |
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Basic information
Public title
Long-Term Effects of Occupation-Based Intervention for Patients with Brain Tumors
Acronym
Occupation-Based Intervention's Long-Term Effects
Scientific Title
Long-Term Effects of Occupation-Based Intervention for Patients with Brain Tumors
Scientific Title:Acronym
Long-Term Effects of Occupation-Based Intervention for Patients with Brain Tumors
Region
| Japan |
Condition
Condition
Brain tumor
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this prospective study is to determine the long-term effects after discharge of postoperative brain tumor resection patients who underwent OBI.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The European Organization for Research and Treatment of Cancer QLQ-C30
Key secondary outcomes
Hospital Anxiety and Depression Scale
Frenchay Activities Index
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who have given consent to participate in this study, who have been diagnosed with a brain tumor, who have undergone occupational therapy with OBI after brain tumor resection, who are 20 years of age or older, and who have scored 24 or more on the Mini Mental Stage Examination.
Key exclusion criteria
Cases with a history of congenital disorders or diseases of the central nervous system, cases with a Mini Mental Stage Examination score of 23 or less, cases in which consent could not be obtained from the patient, and other cases in which the principal investigator judged that the subject was inappropriate.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Syun |
| Middle name | |
| Last name | Ito |
Organization
Shinshu University Hospital
Division name
Rehabilitation Department
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto City, Nagano
TEL
0263-37-2836
itosyun@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Syun |
| Middle name | |
| Last name | Ito |
Organization
Shinshu University Hospital
Division name
Rehabilitation Department
Zip code
390
Address
3-1-1 Asahi, Matsumoto, Nagano
TEL
0263-37-2836
Homepage URL
itosyun@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University Hospital
Institute
Department
Personal name
Funding Source
Organization
without
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
Shinshu University Hospital
Address
3-1-1 Asahi, Matsumoto City, Nagano
Tel
0263-37-2836
itosyun@shinshu-u.ac.jp
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
| 2023 | Year | 01 | Month | 15 | 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
| 2022 | Year | 12 | Month | 12 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 12 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 30 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective observational study
Management information
Registered date
| 2023 | Year | 01 | Month | 08 | Day |
Last modified on
| 2023 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056939
| Research Plan | |
|---|---|
| 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 |
