Skip to content

Longitudinal Study on the QoL of Pediatric Patients After HSCT and Its Influencing Factors

Longitudinal Study on the Quality of Life of Pediatric Patients After Hematopoietic Stem Cell Transplantation and Its Influencing Factors

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06026839
Enrollment
250
Registered
2023-09-07
Start date
2023-10-30
Completion date
2024-12-31
Last updated
2023-10-23

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

Conditions

Acute Leukemia, Thalassemia Major

Keywords

hematopoietic stem cell transplantation, children, quality of life

Brief summary

Objective: To longitudinally track the dynamic changes in the survival quality of pediatric patients after hematopoietic stem cell transplantation at different time points within 1 year post-transplantation, analyze the influencing factors of survival quality at each time point, identify independent risk factors that can be intervened, provide reference for medical staff to recognize survival quality problems early, guide the dynamic management of clinical survival quality, and formulate continuation care management plans. Methods: This study adopted a repeated measurement study design. A total of 250 pediatric patients who underwent hematopoietic stem cell transplantation in three tertiary hospitals in Guangdong Province from August 2023 to December 2025 and met the research standards were selected as the research subjects. The Childhood Health Assessment Questionnaire Transplant Module 3.0 Chinese Version was used to evaluate the survival quality of the patients at six time points: 1 week before pre-treatment (T0), the day of stem cell infusion (T1), 1 month (T2), 3 months (T3), 6 months (T4), and 1 year (T5) after transplantation. Statistical methods for repeated measures were used to analyze the relevant information, and mixed-effect linear models were used to analyze the influencing factors of survival quality at the six time points, and to identify independent risk factors.

Detailed description

Objective: longitudinal tracking hematopoietic stem cell transplantation in 1 years after transplantation in different time points of the quality of life dynamic change trajectory, analyze the factors of quality of each time point, looking for independent risk factors for intervention, early identification of life quality for medical staff, guide the clinical quality of life dynamic management and continuation of nursing management plan to provide reference basis. Methods: In this study, 250 children with routine HSCT transplantation were selected from August 2023 to December 2025 (T1), 1 month (T2), 3 months after transplantation, 1 year after transplantation (T5). Statistical analysis of relevant information was performed using repeated measures, and the influencing factors of QOL at six time points were used to identify their independent risk factors.

Interventions

OTHERConventional nursing

Conventional nursing

Sponsors

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

1. children aged between 0 and 18 years old who will receive a stem cell infusion 2. conscious, have a certain level of cognitive ability and be able to express their physical and psychological state accurately 3. If the child is under 8 years old, their caregiver should have a primary school or higher education level with sufficient reading comprehension and expression abilities 4. both the child and the legal guardian are informed and consent to participate in the study

Exclusion criteria

1. the child has a history of mental illness 2. the child has severe organ failure or other serious complications involving the heart, brain, lungs, liver, kidneys, and other organs

Design outcomes

Primary

MeasureTime frameDescription
PedsQL™ 3.02023.6.30-2024.12.31the Chinese mandarin version of PedsQL™ 3.0 transplant module

Countries

China

Contacts

Primary ContactTing Zhong
33557423@163.com81332009

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026