Clinical trial NCT06026839: Longitudinal Study on the QoL of Pediatric Patients After HSCT and Its Influencing Factors
Official title: Longitudinal Study on the Quality of Life of Pediatric Patients After Hematopoietic Stem Cell Transplantation and Its Influencing Factors
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Thalassemia Major
Acute Leukemia
Keywords: hematopoietic stem cell transplantation
children
quality of life
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2023-09-07
Enrollment: 250
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: PedsQL™ 3.0
timeFrame: 2023.6.30-2024.12.31
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
References: