UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049983 |
|---|---|
| Receipt number | R000056763 |
| Scientific Title | Psychological support and exercise intervention to increase resilience to life adaptation -single-center study of patients with hematopoietic tumors- |
| Date of disclosure of the study information | 2023/01/10 |
| Last modified on | 2024/01/20 20:52:29 |
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Basic information
Public title
Psychological support and exercise intervention to increase resilience to life adaptation
-single-center study of patients with hematopoietic tumors-
Acronym
Rehabilitation to increase the resilience of patients with hematopoietic tumors
Scientific Title
Psychological support and exercise intervention to increase resilience to life adaptation
-single-center study of patients with hematopoietic tumors-
Scientific Title:Acronym
Rehabilitation to increase the resilience of patients with hematopoietic tumors
Region
| Japan |
Condition
Condition
hematologic malignancy
Classification by specialty
| Hematology and clinical oncology | Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Examining the effects of interventions that combine exercise therapy and mindfulness training on resilience.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Connor-Davidson Resilience Scale
Key secondary outcomes
Profile of Mood States2
Autonomic nervous system
Attention bias score
Locomotor activity
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Exercise therapy
Mindfulness training
Interventions/Control_2
Exercise therapy
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Patients with hematopoietic tumors receiving chemotherapy or radiation therapy who were informed of their condition at least 2 weeks ago.
(2) Hematopoietic tumor patients prescribed occupational therapy.
(3) Patients with Performance Status of 2 or less.
Key exclusion criteria
(1) Patients with central illness.
(2) Patients with a history of mental illness such as depression and anxiety.
(3) Patients with cognitive decline.
(4) Patients with serious autonomic side effects from chemotherapy.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tetsuya |
| Middle name | |
| Last name | Okihara |
Organization
Saitama Medical University International Medical Center
Division name
Rehabilitation center
Zip code
350-1298
Address
1397-1, Yamane, Hidaka, Saitama
TEL
042-984-4367
to4601@5931.saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuya |
| Middle name | |
| Last name | Okihara |
Organization
Saitama Medical University International Medical Center
Division name
Rehabilitation center
Zip code
350-1298
Address
1397-1, Yamane, Hidaka, Saitama
TEL
042-984-4367
Homepage URL
to4601@5931.saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University International Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Medical University International Medical Center, Center for Clinical Research Integrity (CCRI), Clinical Research IRB Secretariat
Address
1397-1, Yamane, Hidaka, Saitama
Tel
042-984-4367
to4601@5931.saitama-med.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 | 10 | 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 | 07 | Month | 13 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 10 | 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
Patient uptake, ongoing trial.
Management information
Registered date
| 2023 | Year | 01 | Month | 06 | Day |
Last modified on
| 2024 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056763
| 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 |
