UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050934 |
|---|---|
| Receipt number | R000057602 |
| Scientific Title | Feasibility study of an cancer rehabilitation program for elderly patients with hematopoietic malignancies |
| Date of disclosure of the study information | 2023/04/27 |
| Last modified on | 2023/04/26 13:38:31 |
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Basic information
Public title
Feasibility study of an cancer rehabilitation program for elderly patients with hematopoietic malignancies
Acronym
Feasibility study of an cancer rehabilitation program for elderly patients with hematopoietic malignancies
Scientific Title
Feasibility study of an cancer rehabilitation program for elderly patients with hematopoietic malignancies
Scientific Title:Acronym
Feasibility study of an cancer rehabilitation program for elderly patients with hematopoietic malignancies
Region
| Japan |
Condition
Condition
Hematopoietic malignancy
Classification by specialty
| Hematology and clinical oncology | Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To confirm the feasibility of a rehabilitation program for patients with hematopoietic malignancies aged 65 years or older
Basic objectives2
Others
Basic objectives -Others
feasibility
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Outpatient rehabilitation implementation rate:
Calculate the proportion of outpatient rehabilitation out of 3-4 planned interventions.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Rehabilitation during inpatient and outpatient chemotherapy for 3 months. During hospitalization, rehabilitation is carried out under the guidance of a therapist.
At the time of outpatient visits, a flow chart is used to select an exercise program that is suitable for oneself. Exercise will be performed at home every day, and the records will be reported at the time of outpatient rehabilitation.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1 Elderly patients with hematopoietic malignancies aged 65 years or older, regardless of gender
2 Subjects who have obtained written consent for this research
Key exclusion criteria
1 Leukemia patients with disseminated intravascular coagulation at the time of admission
2 Subjects whose prognosis is expected to be less than 6 months
3 Those who score less than 18 on the Japanese version of the Mini-Mental State Examination (MMSE-J)
4 Those who are judged to be ineligible by the attending physician
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Sonoko |
| Middle name | |
| Last name | Kamoshita |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of hematology
Zip code
474-8511
Address
7-430 Morioka-cho Obu City,Aichi Prefecture
TEL
0562-46-2311
skamoshita@ncgg.go.jp
Public contact
Name of contact person
| 1st name | Youtaka |
| Middle name | |
| Last name | Yada |
Organization
National Center for Geriatrics and Gerontology
Division name
Research Promotion Office Research and Medical Division Planning and Management Department
Zip code
474-8511
Address
7-430 Morioka-cho Obu City,Aichi Prefecture
TEL
0562-46-2311
Homepage URL
yaday@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
Japan health research promotion bureau
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Geriatrics and Gerontology
Address
Morioka-cho Obu City,Aichi Prefecture
Tel
0562-46-2311
yaday@ncgg.go.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 | 04 | Month | 27 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 10 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2024 | 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 | 04 | Month | 26 | Day |
Last modified on
| 2023 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057602
