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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000022141
Receipt No. R000025519
Scientific Title Stress properties of the patients with Hematologic Malignancies. -Effect of cognitive-behavioral therapy program combines exercise therapy on autonomic nerve function-
Date of disclosure of the study information 2016/04/29
Last modified on 2019/11/12

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Basic information
Public title Stress properties of the patients with Hematologic Malignancies.
-Effect of cognitive-behavioral therapy program combines exercise therapy on autonomic nerve function-
Acronym An intervention study to stress attenuation and enhancement of locomotor activity in patients with Hematologic Malignancies.
Scientific Title Stress properties of the patients with Hematologic Malignancies.
-Effect of cognitive-behavioral therapy program combines exercise therapy on autonomic nerve function-
Scientific Title:Acronym An intervention study to stress attenuation and enhancement of locomotor activity in patients with Hematologic Malignancies.
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 To verify the intervention combined with exercise and the attention bias modification method based on cognitive behavioral therapy, that give to attenuate the symptomatic anxiety and the gain in an amount of locomotor activity.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Profile of Mood States
Key secondary outcomes Autonomic nervous system
Salivary amylase activity
Locomotor activity

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Single blind -participants 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
Attention bias modification (ABM)
Cognitive behavioral therapy
Interventions/Control_2 Exercise therapy
Placebo ABM
Stretching
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
18 years-old <
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria (1) The patients with leukemia and malignant lymphoma who scheduled for chemotherapy or hematopoietic stem cell transplantation, they has been prescribed occupational therapy after the announcement by doctor past two weeks.
(2) Any person can be more than 40 minutes sitting at a position holds.
Key exclusion criteria (1) merging the central disease
(2) depression and history of mental disorders of anxiety
(3) the cognitive decline admit persons
(4) a person who has exhibited serious side effects on the autonomic nervous with chemotherapy
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Kohei
Middle name
Last name Koizumi
Organization Saitama Medical University International Medical Center
Division name Rehabilitation center
Zip code 350-1298
Address 1397-1, Yamane, Hidaka, Saitama 350-1298, Japan
TEL 042-984-4367
Email izumiko@saitama-med.ac.jp

Public contact
Name of contact person
1st name Kohei
Middle name
Last name koizumi
Organization Saitama Medical University International Medical Center
Division name Rehabilitation center
Zip code 350-1298
Address 1397-1, Yamane, Hidaka, Saitama 350-1298, Japan
TEL 042-984-4367
Homepage URL
Email izumiko@saitama-med.ac.jp

Sponsor
Institute Saitama Medical University International Medical Center
Institute
Department

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
Address 1397-1, Yamane, Hidaka, Saitama 350-1298, Japan
Tel 042-984-4367
Email izumiko@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
2016 Year 04 Month 29 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 30
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 No longer recruiting
Date of protocol fixation
2015 Year 09 Month 18 Day
Date of IRB
2015 Year 09 Month 18 Day
Anticipated trial start date
2015 Year 10 Month 01 Day
Last follow-up date
2020 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
2016 Year 04 Month 29 Day
Last modified on
2019 Year 11 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025519

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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