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临床试验/NCT04186923
NCT04186923已完成不适用

Familien-SCOUT: Comprehensive Support for Families With a Parent Suffering From Cancer

RWTH Aachen University3 个研究点 分布在 1 个国家目标入组 472 人开始时间: 2019年10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
472
试验地点
3
主要终点
Hospital Anxiety and Depression Scale (HADS

研究概览

简要总结

When a parent with minor children falls ill with cancer, it is extremely stressful for all of the family members, including the partner and children. Familiar everyday routines are often disrupted even at an early stage, and for a prolonged period. Financial difficulties, the threat represented by the uncertain course of the disease, and worries about the children's future have a cumulative effect. The affected families are thereby pushed to their limits organizationally and emotionally. The burden involved tends to be underestimated, and secondary psychological conditions often develop among all the family members. They often do not have adequate access to support.

The aim of this project is to establish a care management system that provides support for families with underage children in which one parent is seriously ill. In order to reduce the burden on families, "family SCOUTS" are to be used who can provide advice and information at an early stage. They are intended to encourage families to discuss things openly, and they should also facilitate access to all the support services available.

The project will evaluate whether the use of family SCOUTS reduces the burden on the family in comparison with families who do not have a family SCOUT. For this purpose, investigations will be carried out before and after the family SCOUTS are deployed. Standardized questionnaires, interviews, and routine data from the participating health-insurance companies will provide the basic data.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • Confirmed ICD diagnosis of cancer in one parent
  • Custody of at least one underage child
  • Adequate knowledge of German
  • Availability of informed consent to participate in the study from the patient and/or healthy parent and linkage to questionnaire data and routine data

排除标准

  • Withdrawal of consent by the ill or healthy parent
  • Relevant cognitive limitation, advanced dementia
  • Individuals who are in relationships of dependence or employment to the project managers or their representatives

结局指标

主要结局

Hospital Anxiety and Depression Scale (HADS

时间窗: Change from Baseline HADS at 9 months

HADS is used to record anxiety and depression in patients with physical diseases or psychogenic physical symptoms.Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. The HADS uses a scale and therefore the data returned from the HADS is ordinal.

次要结局

  • Parenting Concerns Questionnaire (PCQ)(baseline and 9 month)
  • Distress Thermometer (DT)(baseline & 9 month)
  • HLS-EU-Q16(3 month)
  • PA-F-P-KF(baseline & 9 month)
  • CaPIN(3 & 9 Month)
  • MOS-SS(3 month)
  • FAD(baseline & 9 month)
  • EQ-5D-5L(baseline, 3 & 9 month)
  • KIDSCREEN-10:(baseline & 9 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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