Clinical trial NCT06488456: Psychometric Properties of the Therapy-Related Symptom Checklist-Children
Official title: Psychometric Properties of the Turkish Version of Therapy-Related Symptom Checklist for Children Scale
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric Leukemia, Acute Myeloid
Pediatric ALL
Keywords: psychometric properties
symptom
pediatrics
nursing care
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2024-07-05
Enrollment: 300
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

Brief 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.

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.

Eligibility criteria: 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:

* 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

Primary outcomes:
measure: Turkish version of the scale
timeFrame: April 2022-December 2024
Secondary outcomes:
measure: frequency of symptoms
timeFrame: April 2022-December 2024
measure: symptom severity
timeFrame: April 2022-December 2024
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University
Study officials:
affiliation: Ege University
name: Seda Ardahan Sevgili, PhD
role: PRINCIPAL_INVESTIGATOR
References: