UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination into the physical activity level and related factor among post allogeneic hematopoietic cell transplantation patients
Title of the study (Brief title)	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	Tatsuya Kishi
Organization	Keio university Graduate School of Health Management
Division name	Nursing
Address	4411 Endo, Fujisawa-shi, Kanagawa
TEL	0466-49-6265
Email	h16707tk@sfc.keio.ac.jp

Public contact
Name of contact person	Tatsuya Kishi
Organization	Keio University Graduate School of Health Management
Division name	Nursing
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 09 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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