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CompletedNCT06488456Updated Feb 28, 2025

Psychometric Properties of the Therapy-Related Symptom Checklist-Children

An observational study in Pediatric Leukemia, Acute Myeloid and Pediatric ALL, sponsored by Ege University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-02-28.

Sponsored by Ege University · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
300
Ages
2 Years to 18 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Pediatric Leukemia, Acute Myeloid
  • Pediatric ALL

Keywords

  • psychometric properties
  • symptom
  • pediatrics
  • nursing care
03

In context

Precursor Cell Lymphoblastic Leukemia-Lymphoma

2,121 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 492 are open to participants now.

This study's enrollment of 300 is above the median of 120 across 313 observational studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.

Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →

Lead sponsor

Ege University is the lead sponsor of 375 studies on the registry; 47 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Children between the ages of 2-18 who are receiving chemotherapy treatment for leukaemia in the relevant clinic/polyclinic

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
300 participants (actual)
Patient registry
No

Interventions

  • OtherTRSC-C

    Data were collected using TRSC-C

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: April 2022-December 2024

Secondary outcomes

  1. frequency of symptoms

    frequency of symptoms related to chemotherapy treatment

    Time frame: April 2022-December 2024

  2. symptom severity

    symptom severity due to chemotherapy treatment

    Time frame: April 2022-December 2024

07

Study locations

1 site
  • Ege University
    Izmir, 35100, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No — Study data are not shared due to ethical rules and laws. If necessary, it will be shared with the relevant parties if requested

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06488456
Lead sponsor
Ege University
Responsible party
SEDA ARDAHAN SEVGİLİ (Assistant Professor, Ege University) — Principal investigator
First posted
Jul 5, 2024
Start date
Apr 1, 2022
Primary completion
Dec 1, 2024
Completion
Feb 1, 2025
Last update
Feb 28, 2025

Study contacts

Seda Ardahan Sevgili, PhD
principal investigator · Ege University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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