Pediatric Leukemia, Acute MyeloidNCT06488456
Psychometric Properties of the Therapy-Related Symptom Checklist-Children
An observational study of Pediatric Leukemia, Acute Myeloid and Pediatric ALL, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
Diagnosis and treatment of childhood cancers is an exhausting process that affects both children and their caring parents physically and mentally. While the survival rate in childhood cancers was 28% in the 1960s, this rate has increased up to 80% with the developments in treatment methods. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Pediatric Leukemia, Acute Myeloid, Pediatric ALL
- What is being tested?
- TRSC-C
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2022to 1 Feb 2025
- 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: Children between the ages of 2-18 who are receiving chemotherapy treatment for leukaemia in the relevant clinic/polyclinic
Who may be able to join
- The patient is between 2-18 years of age
- The patient has received chemotherapy treatment at least twice,
- The patient/caregiver parent speaks Turkish and is open to communication
- Volunteering to participate in the study.
Who cannot join
- The patient is younger than 2 years of age
- The patient has never received chemotherapy
- The subject/caregiver parent does not speak Turkish
- The patient is being treated for a disease other than leukemia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Psychometric Properties of the Turkish Version of Therapy-Related Symptom Checklist for Children Scale
Diagnosis and treatment of childhood cancers is an exhausting process that affects both children and their caring parents physically and mentally. While the survival rate in childhood cancers was 28% in the 1960s, this rate has increased up to 80% with the developments in treatment methods. Although the main methods used in cancer treatment today are surgical treatment, radiotherapy, and immunotherapy, the main component of cancer treatment is chemotherapy. Improvements in chemotherapy protocols have increased survival; however, the use of high-dose chemotherapy may increase the frequency and severity of symptoms that may be seen in children. Therefore, diagnosis and management of treatment-related symptoms in the pediatric population receiving chemotherapy treatment as soon as possible is of vital importance as it will significantly affect the quality of life of children. In this context, this study aimed to add to the national literature by conducting a Turkish validity and reliability study of a checklist suitable for the use of health professionals in clinics for monitoring the side effects of chemotherapy. In the study, validity and reliability tests will be performed for intercultural scale adaptation.
Read the detailed description
Leukaemias are the most common type of cancer in children and young people, accounting for 1/3 of all cancers in the population. Most childhood leukaemias are acute lymphocytic leukaemia (ALL), while the rest of the cases are acute myeloid leukaemia (AML). In childhood, ALL peaks at the age of 2-4 years. AML, on the other hand, can be seen throughout childhood and is more common in children under 2 years of age and in adolescents. Chronic leukaemias are rarely seen in children.
After the leukaemia is diagnosed and the type of leukaemia is determined, the treatment protocol is decided according to the risk group of the disease. The main treatment for childhood leukaemia is chemotherapy. For children in the high-risk group, high-dose chemotherapy may be given together with stem cell transplantation. Treatment of leukaemias can last 2-3 years with maintenance treatment, depending on the type and risk group. Chemotherapy is known to cause many side effects in both adults and children. The most well-known of these side effects are nausea and vomiting, loss of appetite, weight loss, mucositis, gastrointestinal system changes and fatigue, alopecia, pain, depression.
Monitoring and effective management of side effects of chemotherapy is one of the most important aspects of cancer treatment. Symptoms resulting from the use of chemotherapies require careful monitoring to identify adverse side effects on patients. During the diagnosis and treatment process of leukaemia, children experience many symptoms at the same time. When these symptoms are both related to each other and occur at the same time, this is called a symptom cluster. Studies emphasise that multiple symptoms are seen in children and adolescents with cancer. When the literature was analysed, it was seen that there were few studies involving the use of checklists to identify symptoms and symptom management, the sample of which consisted of patients and their parents in Turkey. However, recognising symptom clusters may provide a better understanding of the structure of multiple symptoms and more effective symptom management. In this context, this study aimed to add to the national literature by conducting a Turkish validity and reliability study of a checklist suitable for the use of health professionals in clinics for monitoring the side effects of chemotherapy.
- Conditions
- Pediatric Leukemia, Acute Myeloid, Pediatric ALL
- Being tested
- TRSC-C
- Keywords
- psychometric properties, symptom, pediatrics, nursing care
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRSC-COther
Data were collected using TRSC-C
What is being measured
The primary outcome is the main question the study is designed to answer.
Turkish version of the scale
Use of the Turkish version of the Theraphy Related Symptom Checklist. Min: 0, Max: 120 points The higher the score, the worse the symptoms.
Measured: April 2022-December 2024
Secondary outcomes (2)
frequency of symptoms
frequency of symptoms related to chemotherapy treatment
Measured: April 2022-December 2024
symptom severity
symptom severity due to chemotherapy treatment
Measured: April 2022-December 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start1 Apr 2022
- Primary completion1 Dec 2024
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Leukemia, Acute MyeloidStudies of the same condition, open and under way.
- More trials run by Ege 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SEDA ARDAHAN SEVGİLİ, Ege University
- Investigators
- Seda Ardahan Sevgili, PhD, Principal investigator, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06488456
- Sponsor's protocol ID
- 22-3.1T/16
- Status last verified
- Aug 2024
- First submitted
- 28 Jun 2024
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study data are not shared due to ethical rules and laws. If necessary, it will be shared with the relevant parties if requested
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychometric Properties of the Turkish Version of Therapy-Related Symptom Checklist for Children Scale
- ClinicalTrials.gov ID
- NCT06488456
- Acronym / sponsor ID
- 22-3.1T/16
- Conditions
- Pediatric Leukemia, Acute Myeloid, Pediatric ALL
- Keywords
- psychometric properties, symptom, pediatrics, nursing care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 5 Jul 2024 (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.
Diagnosis and treatment of childhood cancers is an exhausting process that affects both children and their caring parents physically and mentally. While the survival rate in childhood cancers was 28% in the 1960s, this rate has increased up to 80% with the developments in treatment methods. Although the main methods used in cancer treatment today are surgical treatment, radiotherapy, and immunotherapy, the main component of cancer treatment is chemotherapy. Improvements in chemotherapy protocols have increased survival; however, the use of high-dose chemotherapy may increase the frequency and severity of symptoms that may be seen in children. Therefore, diagnosis and management of treatment-related symptoms in the pediatric population receiving chemotherapy treatment as soon as possible is of vital importance as it will significantly affect the quality of life of children. In this context, this study aimed to add to the national literature by conducting a Turkish validity and reliability study of a checklist suitable for the use of health professionals in clinics for monitoring the side effects of chemotherapy. In the study, validity and reliability tests will be performed for intercultural scale adaptation.
Detailed description
Leukaemias are the most common type of cancer in children and young people, accounting for 1/3 of all cancers in the population. Most childhood leukaemias are acute lymphocytic leukaemia (ALL), while the rest of the cases are acute myeloid leukaemia (AML). In childhood, ALL peaks at the age of 2-4 years. AML, on the other hand, can be seen throughout childhood and is more common in children under 2 years of age and in adolescents. Chronic leukaemias are rarely seen in children.
After the leukaemia is diagnosed and the type of leukaemia is determined, the treatment protocol is decided according to the risk group of the disease. The main treatment for childhood leukaemia is chemotherapy. For children in the high-risk group, high-dose chemotherapy may be given together with stem cell transplantation. Treatment of leukaemias can last 2-3 years with maintenance treatment, depending on the type and risk group. Chemotherapy is known to cause many side effects in both adults and children. The most well-known of these side effects are nausea and vomiting, loss of appetite, weight loss, mucositis, gastrointestinal system changes and fatigue, alopecia, pain, depression.
Monitoring and effective management of side effects of chemotherapy is one of the most important aspects of cancer treatment. Symptoms resulting from the use of chemotherapies require careful monitoring to identify adverse side effects on patients. During the diagnosis and treatment process of leukaemia, children experience many symptoms at the same time. When these symptoms are both related to each other and occur at the same time, this is called a symptom cluster. Studies emphasise that multiple symptoms are seen in children and adolescents with cancer. When the literature was analysed, it was seen that there were few studies involving the use of checklists to identify symptoms and symptom management, the sample of which consisted of patients and their parents in Turkey. However, recognising symptom clusters may provide a better understanding of the structure of multiple symptoms and more effective symptom management. In this context, this study aimed to add to the national literature by conducting a Turkish validity and reliability study of a checklist suitable for the use of health professionals in clinics for monitoring the side effects of chemotherapy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children between the ages of 2-18 who are receiving chemotherapy treatment for leukaemia in the relevant clinic/polyclinic
Key inclusion criteria (4 listed)
- The patient is between 2-18 years of age
- The patient has received chemotherapy treatment at least twice,
- The patient/caregiver parent speaks Turkish and is open to communication
- Volunteering to participate in the study.
Key exclusion criteria (4 listed)
- The patient is younger than 2 years of age
- The patient has never received chemotherapy
- The subject/caregiver parent does not speak Turkish
- The patient is being treated for a disease other than leukemia
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 |
|---|---|---|
| TRSC-CData were collected using TRSC-C | Other | – |
Primary outcome
Turkish version of the scale
Time frame: April 2022-December 2024
Use of the Turkish version of the Theraphy Related Symptom Checklist. Min: 0, Max: 120 points The higher the score, the worse the symptoms.
2 secondary outcomes
frequency of symptoms
Time frame: April 2022-December 2024
symptom severity
Time frame: April 2022-December 2024
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Individual participant dataSharing planned: No. Study data are not shared due to ethical rules and laws. If necessary, it will be shared with the relevant parties if requested
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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.
Seda Ardahan Sevgili, PhD principal investigator
Ege University
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 Pediatric Leukemia, Acute Myeloid and Pediatric ALL, run by Ege University at 1 site in Turkey (Türkiye).
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 4 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: finished, as of the sponsor's last update on 28 Feb 2025. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Turkish version of the scale (time frame: April 2022-December 2024). 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 28 Feb 2025.