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

NCT06026839 | Unknown

• 1 other identifier: SYSKY-2022-339-01
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Thalassemia Major; Acute Leukemia

Keywords

hematopoietic stem cell transplantation; children; quality of life

Outcome Measures

Primary Outcomes (1)

• PedsQL™ 3.0

  the Chinese mandarin version of PedsQL™ 3.0 transplant module

  2023.6.30-2024.12.31

Interventions

Conventional nursing OTHER

Conventional nursing

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This is a planned study on hematopoietic stem cell transplantation for children aged between 0 and 18 years old who will receive a stem cell infusion. The children must be conscious, have a certain level of cognitive ability and be able to express their physical and psychological state accurately. 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. It is important that both the child and the legal guardian are informed and consent to participate in the study.

You may qualify if:

• children aged between 0 and 18 years old who will receive a stem cell infusion
• conscious, have a certain level of cognitive ability and be able to express their physical and psychological state accurately
• 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
• both the child and the legal guardian are informed and consent to participate in the study

You may not qualify if:

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

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510030, China

Location

MeSH Terms

Conditions

beta-Thalassemia

Condition Hierarchy (Ancestors)

Thalassemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Ting Zhong

CONTACT

81332009; 33557423@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: September 7, 2023
• Study Start: October 30, 2023
• Primary Completion: October 30, 2024
• Study Completion: December 31, 2024
• Last Updated: October 23, 2023

Record last verified: 2023-10

Locations

CN (1)