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临床试验/NCT06488456
NCT06488456已完成不适用

Psychometric Properties of the Turkish Version of Therapy-Related Symptom Checklist for Children Scale

Ege University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2022年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
300
试验地点
1
主要终点
Turkish version of the scale

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
2 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

Turkish version of the scale

时间窗: 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.

次要结局

  • frequency of symptoms(April 2022-December 2024)
  • symptom severity(April 2022-December 2024)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

SEDA ARDAHAN SEVGİLİ

Assistant Professor

Ege University

研究点 (1)

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