Psychometric Properties of the Therapy-Related Symptom Checklist-Children

NCT06488456 | Completed DMC

• 1 other identifier: 22-3.1T/16
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Leukemia, Acute Myeloid; Pediatric ALL

Keywords

psychometric properties; symptom; pediatrics; nursing care

Outcome Measures

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.

  April 2022-December 2024

Secondary Outcomes (2)

• frequency of symptoms

  April 2022-December 2024

• symptom severity

  April 2022-December 2024

Interventions

TRSC-C OTHER

Data were collected using TRSC-C

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University

Izmir, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Seda Ardahan Sevgili, PhD

  Ege University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 5, 2024
• Study Start: April 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: February 1, 2025
• Last Updated: February 28, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)