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

October 20, 2023 updated by: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510030
        • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
PedsQL™ 3.0
Time Frame: 2023.6.30-2024.12.31
the Chinese mandarin version of PedsQL™ 3.0 transplant module
2023.6.30-2024.12.31

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 30, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 21, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 4, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 7, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 23, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 20, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SYSKY-2022-339-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Since the study involves vulnerable populations, consent from guardians must be obtained before further data sharing can take place. This is to protect research subjects and adhere to ethical guidelines. During the process of data sharing, strict control over data usage is needed to ensure confidentiality and security of the data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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