UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050074 |
|---|---|
| Receipt number | R000057032 |
| Scientific Title | Changes in physical function and quality of life and cost-effectiveness of rehabilitation in patients with hematopoietic tumors |
| Date of disclosure of the study information | 2023/01/18 |
| Last modified on | 2023/01/18 18:56:17 |
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Basic information
Public title
Changes in physical function and quality of life and cost-effectiveness of rehabilitation in patients with hematopoietic tumors
Acronym
Effectiveness of rehabilitation in patients with hematopoietic tumors
Scientific Title
Changes in physical function and quality of life and cost-effectiveness of rehabilitation in patients with hematopoietic tumors
Scientific Title:Acronym
Effectiveness of rehabilitation in patients with hematopoietic tumors
Region
| Japan |
Condition
Condition
Patients with hematopoietic tumors
Classification by specialty
| Hematology and clinical oncology | Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to develop a rehabilitation program to maintain and improve physical function and quality of life based on the Japanese guidelines for the evaluation of medical technology, and to clarify the changes in physical function and quality of life resulting from systematic rehabilitation for hematopoietic tumor patients undergoing chemotherapy. At the same time, cost-effectiveness in terms of health economics was also examined.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of incremental cost-effectiveness of intervention and control groups
Key secondary outcomes
Changes in physical function, ADL/activity and utility values during and after 1 year of rehabilitation 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
Based on cancer rehabilitation guidelines and previous studies, a systematic rehabilitation program was designed for hematopoietic tumor patients undergoing chemotherapy. In addition to balance exercises, resistance training, and stretching, which are known to be effective for physical functions, aerobic exercise, which is known to be effective for fatigue and QOL, was incorporated into the program, which was supposed to be performed 20-40 minutes a day, 4-5 days a week. In addition, a pamphlet (attached) is provided at the beginning of rehabilitation, and the program is systematic and comprehensive, including education on the necessity and benefits of exercise, as well as guidance on independent training so that the patient can continue exercising after discharge.
Interventions/Control_2
Rehabilitation is delegated to each therapist. The rehabilitation program includes aerobic exercise, resistance training, balance exercises, and stretching, but does not specify the combination of exercise types, frequency or frequency.
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 admitted in March 2020 or later
(2) Patients with hematopoietic tumor over 20 years old who are admitted to our hematology department and undergoing chemotherapy, and who are undergoing cancer rehabilitation for the first time
Key exclusion criteria
(1) Patients who died during the course of hospitalization or during the study period
(2) Patients whose level of consciousness or general condition deteriorated during the course of hospitalization or during the study period and for whom rehabilitation evaluation could not be performed.
(3) Patients who could not give consent for this study and rehabilitation.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Chika |
| Middle name | |
| Last name | Kondo |
Organization
St. Marianna university of medicine Yokohama Seibu hospital
Division name
rehabilitation division
Zip code
2410811
Address
Kanagawa Prefecture,Yokohama City, Asahi-ku,Yasashityo1197-1
TEL
0453661111
chika-kondo@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | CHIKA |
| Middle name | |
| Last name | KONDO |
Organization
St. Marianna university of medicine Yokohama Seibu hospital
Division name
rehabilitation division
Zip code
2410811
Address
Kanagawa Prefecture,Yokohama City, Asahi-ku,Yasashityo1197-1
TEL
0453661111
Homepage URL
chika-kondo@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna university of medicine Yokohama Seibu hospital
Institute
Department
Personal name
Chika Kondo
Funding Source
Organization
nothing
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
St. Marianna university
Address
Kanagawa Prefecture, Kawasaki City,Miyamae-ku,Sugao 2-16-1
Tel
044-977-8111
k-sienbu.mail@marianna-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 | 18 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 01 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 01 | Month | 18 | Day |
Last modified on
| 2023 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057032
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
