UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043614 |
|---|---|
| Receipt number | R000049799 |
| Scientific Title | Effectiveness of Occupation-Based Intervention for Brain Tumor Patients |
| Date of disclosure of the study information | 2021/03/25 |
| Last modified on | 2023/01/08 22:05:59 |
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Basic information
Public title
Effectiveness of Occupation-Based Intervention for Brain Tumor Patients
Acronym
Effectiveness of Occupation-Based Intervention for Brain Tumor Patients
Scientific Title
Effectiveness of Occupation-Based Intervention for Brain Tumor Patients
Scientific Title:Acronym
Effectiveness of Occupation-Based Intervention for Brain Tumor Patients
Region
| Japan |
Condition
Condition
Brain tumor
Classification by specialty
| Neurosurgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether occupational therapy based on OBI for patients with brain tumors is effective in maintaining and improving the QOL of patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
As a primary outcome, QOL's The European Organization for Research and Treatment of Cancer QLQ-C30 will be evaluated before and during the final intervention.
Key secondary outcomes
Secondary outcomes include the National Institutes of Health Stroke Scale, Brunnstrom stage, grip strength, and knee extension muscle strength. We will implement a walking speed of 10m as a walking ability. The Mini Mental State Examination will be conducted as a cognitive function. Functional independence measure and Barthel index are implemented as ADL ability. As a mental function, we will carry out the Hospital Anxiety and Depression Scale. The above evaluation will be performed before the intervention and at the time of the final intervention.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Create a list of patients who will be hospitalized for brain tumor resection and undergo rehabilitation intervention from April 1, 2021 to January 31, 2022. Explain the study to patients who meet the eligibility criteria and obtain their consent. Initial evaluation is performed before surgery and intervention is started after surgery. In the occupation-based intervention implementation group, clear goals are set using work selection decision support software, and work-based interventions are implemented. The intervention is 60 minutes, two-thirds perform meaningful work interventions based on life history, and one-third perform functional exercises. The frequency of intervention is 5 times a week.
Interventions/Control_2
From January 1, 2020 to March 31, 2021, we will prepare a list of patients who will be hospitalized for the purpose of brain tumor resection and will undergo rehabilitation intervention. Explain the study to patients who meet the eligibility criteria and obtain their consent. Initial evaluation is performed before surgery and intervention is started after surgery. In the occupation-based intervention non-execution group, two-thirds practiced functions and one-third performed activities of daily living, without using goal setting tools such as work selection decision support software and Canadian Occupational Performance Measure. Instrumental Activities of Daily Living Practice. The frequency of intervention is 5 times a week.
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
The selection criteria were cases in which consent was obtained for participation in this study, cases diagnosed as brain tumors, cases in which rehabilitation intervention was performed after brain tumor removal, cases over 20 years old, and cases with Mini Mental Stage Examination 24 points or more.
Key exclusion criteria
Exclusion criteria include cases with a history of congenital disorders or diseases in the central nervous system, cases with a Mini Mental Stage Examination of 23 points or less, cases in which the consent of the patient was not obtained, and other cases in which the principal investigator is inappropriate as a subject. The case was judged to be.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Ito |
| Middle name | |
| Last name | Syun |
Organization
Shinshu University Hospital
Division name
Rehabilitation department
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto City, Nagano Prefecture
TEL
0263-37-2836
itosyun@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Ito |
| Middle name | |
| Last name | Syun |
Organization
Shinshu University Hospital
Division name
Rehabilitation department
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto City, Nagano Prefecture
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 Occupational Therapists Association
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 Prefecture
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
信州大学医学部附属病院（長野県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 03 | Month | 25 | 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
42
Results
Post-intervention comparison of the intervention and control groups showed significant improvement in HADS-A items in the intervention group (p <0.05). The pre- and post-intervention comparison of the control group showed significant worsening in the 10-meter walk (maximal) after the intervention (p <0.05). Pre- and post-intervention comparisons of the intervention group showed significant worsening in overall quality of life, insomnia, and HADS-D after the intervention (p < 0.05).
Results date posted
| 2023 | Year | 01 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The intervention group consisted of 1 male and 5 females. the mean age was 42.8years, and the who grade was 1.8. The mean hospital stay was 17.3 days, and the mean postoperative stay was 10.3days.
The gender of the control group consisted of 2 males and 4 females. The mean age was 54.3years, and the who grade was 2.8. The mean hospital stay was 17.8 days, and the mean postoperative stay was 11.2days.
Participant flow
The subjects were patients who had been diagnosed with brain tumors and had undergone tumor resection, and were hospitalized between January 1, 2020 and March 31, 2021. In the intervention group, occupational therapists interviewed patients using ADOC 4 days after surgery, when their general condition had settled down, to identify occupational therapy goals. In the interview, the subjects were asked about "what they want to be able to do," "what they want to try newly," "what they have trouble doing," "what they are worried about," "what they want to do," and "what they want to do. The subjects were asked to select important tasks applicable to "things they want to be able to do," "things they want to try newly," "things they are having trouble doing," "things they are worried about," and "things they need to be able to do. Then, two-thirds of the participants received intervention for the meaningful tasks selected by ADOC, and one-third received functional practice associated with the tasks selected by ADOC. For example, when the ADOC-selected task was cooking, a situation was set up that simulated the home environment, and the participants practiced making items that they frequently made at home for the number of family members. At the final intervention, the participants were given specific written instructions for the tasks selected in the goal setting.
In the control group, after assessment of motor and cognitive functions, two-thirds of the participants practiced functions, and one-third practiced Activities of Daily Living (ADL) and Instrumental Activities of Daily Living. Goal-setting tools such as ADOC and COPM were not used. Functional exercises included aerobic exercise, strength exercises, and balance exercises (modified Borg Scale score 4 or higher).
Adverse events
Outcome measures
Patient characteristics such as gender, age, disease, grade, length of hospitalization, and postoperative period were extracted from the medical records. Muscle strength was assessed by grip strength, which was measured using a Jaymer-type hydraulic grip strength meter. Walking speed was assessed using the 10 meter walking test (10MWT). Participants were instructed to walk as fast and as comfortably as possible without running on a 10 m sidewalk in a clinical setting. Cognitive function was assessed using the MMSE-J. ADL was assessed using the Functional Independence Measure (hereafter, FIM). Mental function was assessed using the Hospital Anxiety and Depression Scale (HADS), which can evaluate anxiety (HADS-A), depression (HADS-D), and the sum of anxiety and depression scores (HADS-A+D). It consists of 14 items: 7 items related to depression and 7 items related to anxiety. Quality of life was assessed using the European Organization for Research and Treatment of Cancer QLQ-C30 {EORTC QLQ-C30 (version 3.0)} ( It consists of 30 questions and can assess overall quality of life and functional and symptom scales. The functional scale is divided into physical, role, cognitive, emotional, and social items. The symptom scale is divided into nausea and vomiting, fatigue, dyspnea, pain, sleep disturbance, anorexia, diarrhea, and economy. Higher scores on the Overall Quality of Life and Functioning scales indicate a better quality of life, while higher scores on the Symptom Scale indicate more severe symptoms.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 12 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 03 | Month | 15 | 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=R000049799
