Longitudinal Study on the Quality of Life of Pediatric Patients After Hematopoietic Stem Cell Transplantation and Its Influencing Factors
Conditions: Thalassemia Major, Acute Leukemia
Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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Clinical study Informed consent
form
Project name: Longitudinal study of the quality of life and its
influencing factors in children after hematopoietic stem cell
transplantation
Sponsor: Sun Yat-sen Memorial Hospital of Sun Yat-sen
University
Version number: Version 4.0
Version date: 2023.4.25
project leader:

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honorific
Children's parents:
Your child will undergo hematopoietic stem cell transplantation, and we
invite you and your child to volunteer to participate in a longitudinal study of
the quality of life and its influencing factors after hematopoietic SCT
transplant. The aim is to evaluate the quality of life of the children after HSCT.

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1, and signed the informed consent form
2. Screscreening for clinical studies
3. If you meet the inclusion conditions, you will receive a regular QOL survey
4. There were 6 time points investigated, namely, 1 week before pretreatment (T 0),
the day of stem cell infusion (T 1), and transplantation
After 1 month (T 2), 3 months (T 3), 6 months (T 4), 1 year (T 5), the
investigation and follow-up included the child's general condition, quality
of survival score, symptom score and condition related content.
5. During the study period, you also have some corresponding responsibilities,
such as visiting the hospital on time, receiving the examination, and
answering the follow-up phone calls in time. At the same time, you also have
the responsibility to truthfully report any physical and mental changes to
you.

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The results of this clinical study are only used for scientific purposes,
so your personal data in your study and study are confidential and will be
protected in accordance with the law. Your name and identity will not be
disclosed and your name will not appear in any study report or public
publication. The hospital ethics committee and researchers, if required by
work, shall have the right to contact all your research data, including
clinical observation form, experimental data, etc.

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This clinical study has been reviewed and approved by the Medical Ethics
Committee of Sun Yat-sen Memorial Hospital, Sun Yat-sen University, and the
protocol design meets the ethical requirements, which will guarantee that your
interests are not infringed in this study.
Your participation in this clinical study is entirely voluntary, you may
refuse to participate or withdraw at any time without discrimination or
retaliation, and your medical treatment and interests will not be affected.
If you have any concerns or questions about your participation in this
study, you should contact:
If you have any complaints or concerns or questions about the way the
study as a study subject, you
The Medical Ethics Committee of the Center can be contacted with:

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1. I have read the informed consent form carefully, and the researchers have given
me detailed explanations and answered my relevant questions,
I am fully aware of the following:
(1) As the legal representative of the minor subject, I will comply with the
subject information requirements and voluntarily participate in and study the
study
Work fully together to truthfully and objectively provide the
researchers with their health status and relevant information before
participating in the study.
(2) The results of this clinical study are only used for scientific research
purposes, except for the ethics committee, researchers, etc., and I participate
in the study and research
Personal data is kept confidential and will be protected in accordance
with the law.
(3) My participation in this clinical study is completely voluntary, and I may
refuse to participate or withdraw from the study at any time without being met
with
Discrimination or retaliation, and my medical treatment and rights and
interests will not be affected.
Also, I declare that:
(1) During the study period, I am willing to cooperate with the nurses to receive
timely follow-up visits, and truthfully report the true situation;
(2) This informed consent form has been received.
Subject legal representative signature: relationship with subject: Contact information:
Date: year month day time minutes
Witness Signature (if necessary): Contact Information:
Date: year month day time minutes
2. I have fully explained and explained to the subject the purpose of the
clinical study, the study methods, operating procedures, and the possible
risks and potential benefits of the subject's participation in the study,
and answered all relevant questions of the subject satisfactorily.

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Investigator (subject subject) signature: Contact:
Date: year month day time minutes

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Honey
children:
You will undergo hematopoietic stem cell transplantation, and your nurse
sister invites you to volunteer to participate in "a longitudinal study of the
quality of life and its influencing factors after hematopoietic stem cell
transplantation."The goal is to know what you do after the transplant.
1. Get your consent
2. If you meet the requirements, the nurse sister will often contact you to ask
about your situation
3. Ask you about the situation for 6 times. Before you enter the warehouse, on the day
of stem cell infusion, 1 month after transplantation, 3 months after transplantation,
and after transplantation
Six months, a year after the transplant, when it's time the nurse sister will
contact your parents and you and ask you if you are sick,
Such as pain, no strength, poor sleep, not eating, itchy skin and so on.
For example, is it painful? How painful is it?
Do you have nausea, vomiting?

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Like being tired?
4, the nurse sister needs your cooperation, for example, when the nurse sister
asks you questions, I hope you can tell your true feelings.
You answer the nurse sister's words, the nurse sister will keep it secret
for you, this is a little secret between us, other else will not know
Tao, so you don't have to worry about being known.
Nurse sister asked your question, if you are not willing to answer, you can
not answer, nurse sister is still the same so like you.
If you don't understand or have any questions when she asked you later,
you can call us. Her phone number is
If you have any questions about the nurse sister, if you feel unhappy and
make you angry, you can call the aunts in the hospital that their phone
number is

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1. I have read the informed consent form carefully, and the nurse sister has made
a detailed explanation to me and answered me
Question of, I already know the following content very well:
(1) As a minor child, I volunteered to truly answer the questions raised by
the nurse sister every time,
(2) I answer the nurse sister's questions is a little secret between me and
the nurse sister, no one else can guide,
(3) I volunteer to answer the nurse's questions. If I do not want to answer
the nurse's questions, I can not answer at any time
Answer, and the nurse elder sister won't blame me, or like me equally.
Also, I declare that:
(1) I am willing to cooperate with the nurse sister to answer the nurse sister's
questions;
(2) This informed consent form has been received.
Signature of the children:
Date: year month day time minutes
2. I have fully explained and explained to the subject the purpose of the
clinical study, the study methods, operating procedures, and the possible
risks and potential benefits of the subject's participation in the study,
and answered all relevant questions of the subject satisfactorily.
Investigator (subject subject) signature: Contact:
Date: year month day time minutes