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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029427
Receipt No. R000033622
Scientific Title Examination into the physical activity level and related factor among post allogeneic hematopoietic cell transplantation patients
Date of disclosure of the study information 2017/10/06
Last modified on 2017/10/05

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Basic information
Public title Examination into the physical activity level and related factor among post allogeneic hematopoietic cell transplantation patients
Acronym Examination into the physical activity level and related factor among post allo-HCT patients
Scientific Title Examination into the physical activity level and related factor among post allogeneic hematopoietic cell transplantation patients
Scientific Title:Acronym Examination into the physical activity level and related factor among post allo-HCT patients
Region
Japan

Condition
Condition Hematologic malignancy
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the physical activity level,related factor and the relationship between physical activity level and HRQOL among post allogeneic hematopoietic cell transplantation patients
Basic objectives2 Others
Basic objectives -Others Relationship between physical activity and HRQOL
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Objective and subjective physical activity level and subjective evaluation of QOL among post allogeneic hematopoietic cell transplantation patients
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
20 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria 1)Patient who gained consent to participate in research
2)Patient aged from 20 to 70
3)Patient who is Within 2 years after allogeneic hematopoietic cell transplantation
4)patient who can understand and write down japanese
5)Patient who is judged by primary doctor
Key exclusion criteria 1)Patient who has Respiratory complications like always needed oxygen inhalation
2)Patient decided by primary doctor that it is not suitable for participating in research because of cognitive/mental disorder
3)Patient with recurrence or secondary cancer
4)Patient who is more than 3 PS(performace status)
5)Patinet who is judged by primary doctor that it is not suitable for participating in research
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tatsuya Kishi
Organization Keio university Graduate School of Health Management
Division name Nursing
Zip code
Address 4411 Endo, Fujisawa-shi, Kanagawa
TEL 0466-49-6265
Email h16707tk@sfc.keio.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuya Kishi
Organization Keio University Graduate School of Health Management
Division name Nursing
Zip code
Address 4411 Endo, Fujisawa-shi, Kanagawa
TEL 0466-49-6265
Homepage URL
Email h16707tk@sfc.keio.ac.jp

Sponsor
Institute Keio University Graduate School of Health Management
Institute
Department

Funding Source
Organization Self-sustaining
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor National Cancer Center Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 国立研究開発法人 国立がん研究センター中央病院

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 06 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
2017 Year 09 Month 15 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Design: Observational cross-sectional study

Management information
Registered date
2017 Year 10 Month 05 Day
Last modified on
2017 Year 10 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033622

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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