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临床试验/NCT06389357
NCT06389357已完成不适用

Efficacy of the Web-based Return-to-school Adaptation Program for Children Diagnosed With Cancer

Gazi University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年5月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
social anxiety

研究概览

简要总结

The aim of this action research is to:

Stage 1: Conduct an in-depth investigation into the adaptation challenges faced by children aged 8-17 who are being treated for cancer during their return to school, from both the children's and parents' perspectives;

Stage 2: Develop a structured, evidence-based, and digitally accessible intervention program that addresses these identified needs;

Stage 3: Evaluate the feasibility and effectiveness of the intervention; and

Ultimately, based on all data gathered throughout the implementation process, continuously refine the intervention and analyze participant feedback holistically in order to establish a sustainable support model.

详细描述

Importance of research There are disease-specific medical and psychosocial difficulties that children with a diagnosis of cancer may experience. Standard school nursing practices can be helpful in meeting the physical, emotional, psychological, social and academic needs of children. However, a standard of care that is decided to be applied on return to school has not been developed. Therefore, it is thought that standard school nursing practices are not sufficient to meet the health and educational needs of children with cancer diagnosis. In the world, plans have been made using practices/methods/models appropriate for the population in the school return process of children followed up with a diagnosis of cancer. It is recommended to develop back-to-school programmes as they can benefit the child, family, peers, teachers and school staff who are followed up with a diagnosis of cancer. In our study, we aim to manage the transition care schematically with the back-to-school protocol to be made between the school-family-hospital, and to ensure care coordination and the safety of the child. The fact that the intervention in the back-to-school adaptation programme will be made to the child, parents, teachers and peers shows a holistic approach to the needs.

Place of application:

It will be performed in the paediatric leukaemia outpatient clinic of the Children's Hospital.

Study Population The population of the study consisted of children who were followed up in the paediatric leukaemia outpatient clinic of the Children's Hospital with a diagnosis of cancer.

Sample of the study In Phase 1, it was observed that after a certain number of interviews, no new themes or concepts emerged, and the data began to repeat previously obtained information. Accordingly, it was concluded that data saturation had been reached, and the data collection process was terminated. The sample for Phase 1 consisted of 12 children and their parents (n = 12).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
8 Years 至 17 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Implementation and Evaluation of the School Re-entry Adaptation Program
  • •Inclusion Criteria
  • •For Children:
  • •Aged between 8 and 17 years Diagnosed with cancer (leukemia, lymphoma, or solid tumor) For children diagnosed with leukemia, currently receiving or having completed maintenance therapy For children diagnosed with other cancer types, treatment has been completed or they are continuing outpatient treatment Have completed the treatment process but have not yet returned to school Have returned to school after treatment but discontinued again due to difficulties managing the adaptation process Have internet access Able to use the internet, computer, and phone Able to speak Turkish Consent to participate in the study
  • •For Parents:
  • •Own a computer or smartphone Have internet access Able to use the internet, computer, and phone Able to speak Turkish Consent to participate in the study

排除标准

  • •For Children:
  • •Requiring special physical and/or mental care Having learning disabilities Having a psychological or medical diagnosis (e.g., severe depression) Diagnosed with brain tumor Diagnosed with osteosarcoma Receiving immunosuppressive therapy Experiencing a major stressful event within the past year (e.g., loss, surgery unrelated to cancer treatment) Preparing to take secondary or higher education entrance exams during the study period
  • •For Parents:
  • •Requiring special physical and/or mental care Having learning disabilities Having a psychological or medical diagnosis (e.g., severe depression)

研究组 & 干预措施

Implementation and evaluation of the school re-entry adaptation program

Experimental

Counselling interviews and workshops will be held simultaneously with the children receiving the web-based training. There are 4 modules in total. The first module lasts 2 weeks. The counselling interview will start in the 2nd week. Implementation will be completed in 5 weeks.

干预措施: training and counselling (Behavioral)

Implementation and evaluation of the school re-entry adaptation program

Experimental

Counselling interviews and workshops will be held simultaneously with the children receiving the web-based training. There are 4 modules in total. The first module lasts 2 weeks. The counselling interview will start in the 2nd week. Implementation will be completed in 5 weeks.

干预措施: Interview (Other)

结局指标

主要结局

social anxiety

时间窗: Before the intervention, before starting school, one month after starting school, three months after starting school

Social anxiety scale fo children-revised. Scores that can be obtained from the scale are between 18-90 and as the scale score increases, the level of social anxiety increases.

coping

时间窗: Before the intervention, before starting school, one month after starting school, three months after starting school

Paediatric Cancer Coping Scale. Scores that can be obtained from the scale are between 0-99 and coping strategies increase as the scale score increases.

back to school readiness

时间窗: Before the intervention, before starting school, one month after starting school, three months after starting school

Back to school readiness scale for children with oncological problems: 7-18 years of age. The score that can be obtained from the scale is between 0 and 152 and a higher score indicates an increase in school readiness.

次要结局

  • process evaluation(1st month and 3rd month after starting school)

研究者

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

Gizem Çakır

Research Assistant, RN, PhD(c)

Gazi University

研究点 (1)

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