UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029427
Receipt number 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 08:47:19

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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 or person

Institute

Keio University Graduate School of Health Management

Institute

Department

Personal name



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

Value
https://center6.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