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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000009546

Enrollment

400

Registered

2012-12-15

Start date

2012-12-07

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Japan

Contacts

Public ContactYasushi Ishida, M.D.

Ehime Prefectural Central Hospital / St.Luke's International Hospital Department of Pediatrics

yaishida@luke.or.jp089-947-1111

Outcome results