Enhancing Adjustment to Parental Cancer: Short-term Counselling for Families. A Randomized, Wait-list Controlled Intervention Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Change of children's quality of life on the health-related quality of life questionnaire (KINDL)
研究概览
简要总结
A parental cancer diagnosis challenges the family's stability and the parent-child relationship. It may impact the children's well-being, so that about one third of them develop clinically relevant levels of psychological distress. Psycho-oncological family-based counselling programs have been shown to elevate children's and parents' well-being. However, there is still a dearth of familial health services in Switzerland, which has also been recognized by the Swiss National Cancer Program (2011-2017).
This study aims to implement and evaluate a short-term family counselling intervention at the Cancer Center of the University Hospital Basel. The primary objective of the study is the enhancement of adjustment to the parental cancer diagnosis. The study seeks secondary to determine the feasibility of the short-term counselling Intervention.
详细描述
This study ist designed as a randomized controlled wait-list Intervention study, which aims to implement and evaluate a short-term family counselling intervention at the Cancer Center of the University Hospital Basel. The study will be divided into two stages: Stage 1 serves as the preparatory work phase, where the intervention manual will be developed as well as the implementation strategy into the hospital. In stage 2 the intervention will be evaluated, with an interim analysis to test for feasibility. The primary objective of the study is the enhancement of adjustment (family, parents and children) to the parental cancer diagnosis. The study seeks secondary to determine the feasibility of the short-term counselling intervention in the Swiss medical setting and to identify predictors for families with continuing psychosocial adjustment problems.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed Consent as documented by signature
- •Diagnosis of any kind of cancer, inclusive relapse, within the last year with an expected survival of at least 8 months
- •Married, cohabiting or single parent
- •At least one child between 1-5 - 18 years
- •German speaking
排除标准
- •The diagnosis is more than 1 year ago
- •Diagnosed patients (parent) not living with their children
- •Diagnosed patients without custody of their children
结局指标
主要结局
Change of children's quality of life on the health-related quality of life questionnaire (KINDL)
时间窗: 6 weeks (change between baseline and week 6)
Enhancement of children's quality of life from T1 (baseline) to T2 (6 weeks) compared to the wait-list control group.
Change of children's behavioral-emotional functioning on the Strengths and Difficulties Questionnaire (SDQ)
时间窗: 6 weeks (change between baseline and week 6)
Enhancement of children's behavioral-emotional functioning from T1 (baseline) to T2 (6 weeks) compared to the wait-list control group.
Change of parent's mental health on the Hospital Anxiety and Depression Scale (HADS)
时间窗: 6 weeks (change between baseline and week 6)
Enhancement of parent's mental health from T1 (baseline) to T2 (6 weeks) compared to the wait-list control group.
Change of family functioning on the Family Adaptability and Cohesion Evaluation Scale (FACES IV)
时间窗: 6 weeks (change between baseline and week 6)
Enhancement of family functioning from T1 (baseline) to T2 (6 weeks) compared to the wait-list control group.
Change of relationship quality on the relationship questionnaire (Partnerschaftsfragebogen PFB)
时间窗: 6 weeks (change between baseline and week 6)
Enhancement of relationship quality from T1 (baseline) to T2 (6 weeks) compared to the wait-list control group.
次要结局
- Medical history characteristics (i.e. cancer diagnosis, cancer treatment) of the participants willing to participate in the counselling with the medical history questionnaire(Through study completion, an average of 2 years)
- Number of participants willing to participate in the counselling(Through study completion, an average of 2 years)
- Sociodemographic characteristics (i.e. age, gender, education) of the participants willing to participate in the counselling with the sociodemographic questionnaire(Through study completion, an average of 2 years)
- Dropout rate during the recruitment and intervention procedure(Through study completion, an average of 2 years)
- Client satisfaction on the Client Satisfaction Questionnaire (CSQ-8)(Measures assessed after 6 weeks)