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临床试验/NCT05806983
NCT05806983尚未招募不适用

Evaluation of the Efficiency of the Technology-Based Psychosocial Empowerment Program for Home Care of Children With Cancer and Their Parents

Gazi University1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2023年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
72
试验地点
1
主要终点
General Self-Efficacy Scale-Pediatric Cancer Version

研究概览

简要总结

This research was planned to evaluate the effectiveness of the technology-based psychosocial empowerment program for home care for children aged 8-18 years with cancer and their parents as a parallel-group randomized controlled study design.The required institutional permission and ethics committee approval was received.The study group of the study consisted of 72 children and parents (intervention group [n=36], control group [n=36]). Data were collected using the descriptive features form, the General Self-Efficacy Scale-Pediatric Cancer Version, the State and Trait Anxiety Inventory for Children, the Pediatric Cancer Coping Scale, the General Self-Efficacy Scale for parents, the Problem-Solving Scale, and the Cope and Adaptatıon Process Scale. The data were stored in the SPSS 25 program.

详细描述

The incidence of childhood cancers has become an important health problem increasing all over the world. Children and parents are affected in many dimensions physically, psychologically, and socially during this experience. The needs of the child and parents are not limited to the treatment period in the hospital. They also need to be supported and strengthened during the home care process. The required institutional permission and ethics committee approval was received. The study group of study consisted of 72 children and parents (intervention group [n=36], control group [n=36]).The technology-based program was applied to children and families for 4-6 weeks through modules on the website. In addition, at the end of each module, online interviews or telephone counseling will be applied.Children and parents in the control group will follow the standard care procedures included in the treatment process. At the end of the study, it was planned to apply website modules to the children and parents in the control group. The research is based on the Psychological Empowerment Theory.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

盲法说明

In the research, it was planned to blind the participant and outcome evaluation.

入排标准

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

入选标准

  • •For children's:
  • •Children between the ages of 8-18, Those receiving cancer treatment (leukemias and solid tumors) and completing the first 2 months of the treatment process, Children with tablets, android phones and internet access Children whose parents and themselves agree to participate in the study, Children who can continue the study for 4-6 weeks,
  • •For primary care parents, Parents who can speak Turkish, Parents who can use computers and android mobile phones, Parents who agreed to participate in the study, Parents who can continue the study for 4-6 weeks,

排除标准

  • •Newly diagnosed children (in induction phase), Children who are in the terminal period or who are treated for relapse, Presence of another important disease (such as chronic disease, psychiatric diagnosis) in the family that may prevent coping, other than the child followed up with the diagnosis of cancer

研究组 & 干预措施

Experimental group

Experimental

-The experimental group that applied the technology-based psychosocial program

干预措施: Technology Based Psychosocial Program (Other)

Control group

No Intervention

Control group receiving standard care

结局指标

主要结局

General Self-Efficacy Scale-Pediatric Cancer Version

时间窗: Change from Baseline level 'Self Efficacy' to 2 months (change is being assessed)

It is a one-dimensional, 10-item scale used to evaluate self-efficacy in children aged 8-18 years with cancer.As the score obtained from the scale increases, the level of self-efficacy also increases.

State-Trait Anxiety Inventory for Children

时间窗: Change from Baseline level 'State-Trait Anxiety' to 2 months (change is being assessed)

The 'State Anxiety Scale' for children between the ages of 8-18 was created to determine what the child feels at that moment, and the 'Trait Anxiety Scale' was created to determine what they usually feel. The higher the score, the higher the anxiety level.

Pediatric Cancer Coping Scale

时间窗: Change from Baseline level 'Pediatric Cancer Coping Scale' to 2 months (change is being assessed)

It was developed to evaluate coping in children aged 7-18 years with cancer diagnosis. The scale consists of 3 sub-dimensions as cognitive coping, problem-focused coping and defensive coping. The higher the score, the higher the coping strategies.

General Self-Efficacy Scale

时间窗: Change from Baseline level 'Self Efficacy' to 2 months (change is being assessed)

It is a one-dimensional scale developed to evaluate the general self-efficacy level of adults.As the score obtained from the scale increases, the level of self-efficacy also increases.

Problem Solving Inventory

时间窗: Change from Baseline level 'Problem Solving Inventory' to 2 months (change is being assessed)

It is a scale that measures the problem solving skills of individuals according to the perception of the individual.The inventory consists of three sub-dimensions: Safe in Problem Solving, Approach Avoidance Style and Personal Control.Low scores from the inventory indicate the ability to produce effective solutions to problems, while high scores indicate the inability to find effective solutions to problems.

Coping and Adaptation Process Scale

时间窗: Change from Baseline level 'Coping and Adaptation Process Scale' to 2 months (change is being assessed)

The scale is a scale that enables individuals to define coping and adaptation strategies in critical and difficult situations. The scale consists of 47 items and five sub-dimensions. Scale items are scored between 1 and 4. As the score obtained from the scale and subscales increases, it is interpreted as the use of effective coping methods increases.

次要结局

  • SSPedi: Symptom Screening Scale in Pediatric Patients(While the intervention continues (1 months), the log records of the scale on the website will be evaluated.)

研究者

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

Hazal Ozdemir Koyu

Research Assistant

Gazi University

研究点 (1)

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