UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049486 |
|---|---|
| Receipt number | R000056353 |
| Scientific Title | Pilot Randomized Controlled Trial of Occupation-Based Intervention for Patients with Brain Tumors |
| Date of disclosure of the study information | 2022/11/15 |
| Last modified on | 2023/01/08 22:14:55 |
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Basic information
Public title
Pilot Randomized Controlled Trial of Occupation-Based Intervention for Patients with Brain Tumors
Acronym
Pilot Randomized Controlled Trial of Occupation-Based Intervention for Patients with Brain Tumors
Scientific Title
Pilot Randomized Controlled Trial of Occupation-Based Intervention for Patients with Brain Tumors
Scientific Title:Acronym
Pilot Randomized Controlled Trial 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 study is to investigate whether occupational therapy based on OBI is effective in maintaining and improving the quality of life of patients with brain tumors.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
the european organization for research and treatment of cancer qlq-c30
Key secondary outcomes
Physical function: Brunnstrom stage (Brs)
Walking ability: 10m walking speed. timed up and go test (TUG)
Hand grip (HG)
Knee extension muscle strength: Hand held dynamometer (HHD)
Cognitive function: Mini Mental State Examination (MMSE-J), Trail Making Test Japan version (TMT-J)
ADL ability: Functional independence measure (FIM), Barthel index (BI)
Mental function: Hospital Anxiety and Depression Scale (HADS)
IADL: Frenchay Activities Index (FAI)
Activity: International Physical Activity Questionnaire (IPAQ)
Work satisfaction and performance: Assistive Decision Making Software for Selecting Tasks (ADOC)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The OBI group will use ADOC to set clear goals and implement a work-based intervention. Two-thirds of the intervention will be meaningful work based on life history, and one-third will be functional practice.The frequency of intervention will be five times a week for both interventions.
Interventions/Control_2
In the IBI group, goal-setting tools such as ADOC and Canadian Occupational Performance Measure are not used, two-thirds of the patients perform functional exercises, and one-third perform ADL/Instrumental Activities of Daily Living exercises.
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. Patients diagnosed with brain tumors. Patients who have undergone rehabilitation intervention after brain tumor resection, are at least 20 years old, and have a MMSE-J score of 24 or higher.
Key exclusion criteria
Patients with a history of congenital disorders or diseases of the central nervous system, MMSE-J score of 23 or less. Cases in which the patient's consent could not be obtained. Other cases in which the principal investigator determines that the subject is not suitable for the study.
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, 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
390-8621
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
Japan Science and Technology Agency
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, 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
| 2022 | Year | 11 | 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 | 11 | Month | 13 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 18 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 30 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 11 | Month | 13 | Day |
Last modified on
| 2023 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056353
