Thalassemia MajorNCT06026839
Longitudinal Study on the QoL of Pediatric Patients After HSCT and Its Influencing Factors
An observational study of Thalassemia Major and Acute Leukemia, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Thalassemia Major, Acute Leukemia
- What is being tested?
- Conventional nursing
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510030
Ting Zhong, 18127880028, 33557423@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Thalassemia Major, Acute Leukemia
- Being tested
- Conventional nursing
- Keywords
- hematopoietic stem cell transplantation, children, quality of life
- Medical subject headings
- beta-Thalassemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional nursingOther
Conventional nursing
What is being measured
The primary outcome is the main question the study is designed to answer.
PedsQL™ 3.0
the Chinese mandarin version of PedsQL™ 3.0 transplant module
Measured: 2023.6.30-2024.12.31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start30 Oct 2023 (estimated)
- Primary completion30 Oct 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thalassemia MajorStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06026839
- Sponsor's protocol ID
- SYSKY-2022-339-01
- Status last verified
- Oct 2023
- First submitted
- 21 Jun 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Study on the Quality of Life of Pediatric Patients After Hematopoietic Stem Cell Transplantation and Its Influencing Factors
- ClinicalTrials.gov ID
- NCT06026839
- Acronym / sponsor ID
- SYSKY-2022-339-01
- Conditions
- Thalassemia Major, Acute Leukemia
- Keywords
- hematopoietic stem cell transplantation, children, quality of life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 30 Oct 2023 (estimated)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 7 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional nursingConventional nursing | Other | – |
Primary outcome
PedsQL™ 3.0
Time frame: 2023.6.30-2024.12.31
the Chinese mandarin version of PedsQL™ 3.0 transplant module
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thalassemia Major and Acute Leukemia, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ting Zhong (81332009, 33557423@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PedsQL™ 3.0 (time frame: 2023.6.30-2024.12.31). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.