UMIN-CTR Clinical Trial

Public title

A cross sectional study of Quality of Life in long-term pediatric survivors after autologous and allogeneic hematopoietic stem cell transplantation

Acronym

QOL in pediatric survivors after hematopoietic stem cell transplantation

Scientific Title

A cross sectional study of Quality of Life in long-term pediatric survivors after autologous and allogeneic hematopoietic stem cell transplantation

Scientific Title:Acronym

QOL in pediatric survivors after hematopoietic stem cell transplantation

Region

Japan

Condition

Hematopoietic stem cell trans-
plantation targeted diseases such as hematological/malignant diseases, primary immunodeficiency and severe congenital metabolic disease

Classification by specialty

Pediatrics

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To improve Quality of Life (QOL) in patients after transplantation by a cross sectional study of QOL in long-term survivors with hematopoietic stem cell transplantation.

Basic objectives2

Others

Basic objectives -Others

QOL

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

We will examine QOL of survivors which assessed by the comprehensive QOL instruments (SF-36 for 16 years or older and PedsQL Generic Core Scale for less than 16 years of age at the time of getting an informed consent), FACT-BMT and VAS described below.
(1) SF-36 or PedsQL Generic Core Scale: Compare QOL of patients with that of same sex, coeval national certified value.
(2) FACT-BMT: Examine factors associated with QOL.
(3) To evaluate the following factors which are associated with QOL
*Donor and type of transplantation in related and un-related allogeneic HSCT
*Allogeneic or autologous HSCT
*Conditioning regimens and total body irradiation
*Years after transplantation, reintegration into society, connubiality and restoration of gonadal function
*Chronic GVHD
*Psychological influence including PTSS
*With or without HSCT
(4) Compare background factors of patients who are engaged in this study with who disapproved or unable to explain this study.
(5) Compare patients who are included in this study and patients who are included in the pediatric study.

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

Not applicable

Age-upper limit

20

years-old

>

Gender

Male and Female

Key inclusion criteria

(1)Patients who received HSCT at younger than 20 years of age.
(2)Patients who were transplanted at pediatric department.
(3)Patients who survived for two years and above after last transplantation without relapse.
(4)Patients who signed a written informed consents by themselves or legal guardians.
(5)Patients who can read Japanese questionnaire.
(6)Patients who are compatible with exclusion criteria.

Key exclusion criteria

(1)Patients who disapproved of TRUMP search.
(2)Patients who are disqualified by his attending physician.

Target sample size

400

Name of lead principal investigator

1st name
Middle name
Last name	Shuichi Taniguchi M.D.

Organization

Late Effects / Quality of Life Working Group, the Japan Society for Hematopietic Cell Tranplantation
(Toranomon Hospital)

Division name

Department of Hematology

Zip code

Address

2-2 Toranomon2-chome, Minato-ku, Tokyo, 105-8470 Japan

TEL

03-3588-1111

Email

taniguchi-s@toranomon.gr.jp

Name of contact person

1st name
Middle name
Last name	Yasushi Ishida, M.D.

Organization

Ehime Prefectural Central Hospital / St.Luke's International Hospital

Division name

Department of Pediatrics

Zip code

Address

83 Kasuga-machi, Matsuyama-city, Ehime 790-0024 Japan

TEL

089-947-1111

Homepage URL

http://jshct.com

Email

yaishida@luke.or.jp

Institute

Late Effects / Quality of Life Working Group, the Japan Society for Hematopietic Cell Tranplantation

Institute

Department

Personal name

Organization

The Clinical research committee of the Japan Society for Hematopietic Cell Tranplantation

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Department of HSCT Data Management and Biostatistics

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2012

Year

12

Month

15

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

No longer recruiting

Date of protocol fixation

2012

Year

12

Month

06

Day

Date of IRB

Anticipated trial start date

2012

Year

12

Month

07

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This is a cross-sectional observational study. Long-term survivors without relapse after hematopoietic stem cell transplantation, who fulfill inclusion criteria, who visited participating centers during the registration period (one year) are the subjects for this study.

Registered date

2012

Year

12

Month

14

Day

Last modified on

2017

Year

01

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010962