跳至主要内容
临床试验/NCT02332226
NCT02332226已完成不适用

The PIFBO-study: Person-centred Information to Parents in Paediatric Oncology - A Randomized Controlled Trial Based Upon a Conceptual Framework for Patient Education

Umeå University2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
2
主要终点
Pediatric Inventory for Parents (compare the mean scoring)

研究概览

简要总结

The aim of this project is to evaluate a person-centred informational intervention aimed at parents of children with cancer.

The following hypotheses will be tested: an informational intervention emanating from the parents' self-identified needs is associated to decreased illness-related parenting stress, decreased post-traumatic stress symptoms, increased received knowledge, decreased anxiety, decreased depression, increased satisfaction with information, and decreased number of health care contacts in parents.

详细描述

BACKGROUND

Parents of children with cancer have great information needs and report that these are not always met. Psychosocial suffering such as stress and anxiety is also common in this group.

INTERVENTION

The intervention in this study builds upon the representational approach for patient education. It emanates from Leventhal's theories about illness representation and educational theories about conceptual change. Central elements in the approach are parental choice of information topics of interest, and a thorough assessment of present parental knowledge before information is given. Each parent in the intervention arm gets four sessions with an intervention nurse.

DESIGN AND METHODS

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
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Being a parent of a child that
  • is diagnosed with a first time occurrence of a malignancy that is curatively treated and
  • was diagnosed two months ago.
  • Further parents must be
  • able to talk, read and write Swedish enough to be able to participate without an interpreter.

排除标准

  • None specific.

结局指标

主要结局

Pediatric Inventory for Parents (compare the mean scoring)

时间窗: baseline up to one year post intervention

An instrument with 42 items measuring both frequency and intensity of stressors related to having a chronically ill child.

次要结局

  • Impact of Event Scale-Revised (compare the mean scoring)(baseline up to one year post intervention)
  • Satisfaction with information (compare the mean scoring)(baseline up to one year post intervention)
  • Anxiety and depression (compare the mean scoring)(baseline up to one year post intervention)
  • Number of health care contacts(baseline up to one year post intervention)
  • Experiences with your Health Care Provider (compare the mean scoring)(baseline up to one year post intervention)
  • Kowledge expectations of significant others and Received knowledge of significant others (compare the mean scorings)(baseline up to one year post intervention)

研究者

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

Anders Ringnér

PhD, Senior lecturer

Umeå University

研究点 (2)

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