UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028975
Receipt number R000033086
Scientific Title A longitudinal study of quality of life in hematopoietic stem cell transplant recipients
Date of disclosure of the study information 2017/09/02
Last modified on 2023/09/14 16:56:42

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Basic information

Public title

A longitudinal study of quality of life in hematopoietic stem cell transplant recipients

Acronym

A longitudinal study of quality of life in hematopoietic stem cell transplant recipients

Scientific Title

A longitudinal study of quality of life in hematopoietic stem cell transplant recipients

Scientific Title:Acronym

A longitudinal study of quality of life in hematopoietic stem cell transplant recipients

Region

Japan


Condition

Condition

Hematological disorders

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The longitudinal evaluation of QOL and the identification of factors affecting QOL in hematopoietic stem cell transplant recipients

Basic objectives2

Others

Basic objectives -Others

QOL

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

QOL changes over time after hematopoietic stem cell transplantation

Key secondary outcomes

Factors affecting QOL after hematopoietic stem cell transplantation


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


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Adult hematological patients who underwent hematopoietic stem cell transplantation at Toranomon Hospital
2. Patients who can answer the QOL questionnaire written in Japanese
3. Patients from whom written informed consent has been obtained

Key exclusion criteria

Patients who are deemed ineligible by the treating physician

Target sample size

700


Research contact person

Name of lead principal investigator

1st name Yuki
Middle name
Last name Asano-Mori

Organization

Toranomon Hospital

Division name

Department of Hematology

Zip code

105-8470

Address

2-2-2, Toranomon, Minato-ku, Tokyo, 105-8470, Japan

TEL

03-3588-1111

Email

yuki-am@toranomon.gr.jp


Public contact

Name of contact person

1st name Yuki
Middle name
Last name Asano-Mori

Organization

Toranomon Hospital

Division name

Department of Hematology

Zip code

105-8470

Address

2-2-2, Toranomon, Minato-ku, Tokyo, 105-8470, Japan

TEL

03-3588-1111

Homepage URL


Email

yuki-am@toranomon.gr.jp


Sponsor or person

Institute

Toranomon Hospital

Institute

Department

Personal name



Funding Source

Organization

Okinaka Memorial Institute for Medical Research

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor

Department of Family Nursing, Division of Health Science and Nursing, Graduate School of Medicine, The University of Tokyo

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Department of Clinical Trial and Research

Address

2-2-2, Toranomon, Minato-ku, Tokyo, 105-8470, Japan

Tel

03-3588-1111

Email

chiken-jim@toranomon.gr.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

2017 Year 09 Month 02 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

551

Results


Results date posted


Results Delayed

Delay expected

Results Delay Reason

Data is currently being analyzed

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

2010 Year 05 Month 17 Day

Date of IRB

2010 Year 05 Month 17 Day

Anticipated trial start date

2010 Year 07 Month 12 Day

Last follow-up date

2022 Year 05 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

A single-center longitudinal study, to analyze QOL changes over time and factors associated with QOL after hematopoietic stem cell transplantation


Management information

Registered date

2017 Year 09 Month 02 Day

Last modified on

2023 Year 09 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033086


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name