FAMOS: The Effect of Psychosocial Intervention for Childhood Cancer Survivors and Their Families: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 185
- 试验地点
- 2
- 主要终点
- Post traumatic stress symptoms (PTSS) in parents measured by Harvard Trauma Questionnaire (HTQ)
研究概览
简要总结
To investigate whether a home-based psychosocial family intervention that takes place shortly after ending the primary medical treatment can help families adjust to their cancer-related psychological issues.
详细描述
The objective of this randomized controlled trial is to investigate whether home-based psychosocial interventions are able to help families of childhood cancer survivors cope with cancer-related psychological issues.
Method: 300 families will be recruited from the four pediatric oncology departments in Denmark where 150 families' will receive a home-based psychosocial intervention and 150 families will be in the control group. The study will take place shortly after the child completes the primary treatment. The primary outcome is post-traumatic stress symptoms (PTSS) in parents and secondary outcomes include among others quality of life, sick-leave, coping strategies and family functioning. Families in the intervention group will receive a 6 session manualized intervention based on a Cognitive Behavioral framework. Four sessions will focus on the parents and two sessions will focus on the child, who had cancer, and his/her siblings. The main goal of the sessions is to teach families how to adapt healthy psychological adjustments to pediatric oncology and prevent PTSS in family members. As a part of the intervention, families will be presented with video clips of other parents discussing how cancer has affected their family, to show common issues in experiencing having a child undergo cancer treatment. Every family member will be asked to complete a set of questionnaires to measure the outcome of the intervention at baseline before the intervention, 6 months follow-up and 12 months follow-up.
It is expected that families in the intervention group experience a larger improvement in their post-traumatic stress symptoms as well as strengthening the family function, quality of life and reducing sick leave compared to the control group.
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
- 年龄范围
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Families of children in the age range of 0-17 years diagnosed with any kind of cancer and treated at one of the four pediatric oncology departments in Denmark are invited to participate in the project after ending primary medical treatment.
排除标准
- •If the child has a severe co-morbidity
- •If the child has a mental disorder at diagnosis
- •If the child is declared terminal ill at the end of treatment (less than 6 months of survival).
- •If the parents and the children do not speak Danish. The participants have to be able to read and answer the questionnaires at the least, to be included in the project.
- •If the parents do not wish to hand in consent form
- •If the family participates in another randomized psychosocial intervention project
结局指标
主要结局
Post traumatic stress symptoms (PTSS) in parents measured by Harvard Trauma Questionnaire (HTQ)
时间窗: Baseline and 6 months
A larger reduction in post traumatic stress symptoms amongst parents of childhood cancer survivors in the intervention group from baseline to 6 months follow up compared to parents in the control group
次要结局
- Post traumatic stress symptoms (PTSS) in parents measured by Harvard Trauma Questionnaire (HTQ)(Baseline and 12 months)
- Post traumatic stress symptoms (PTSS) in childhood cancer survivors and their siblings measured by Harvard Trauma Questionnaire (HTQ), Daryl or Pediatric Emotional Distress Scale (PEDS)(Baseline, 6 months and 12 months)
- Family psychosocial functioning measured by Psychological Assessment Tool 2.0 (PAT2.0) and Family Impact Module 2.0 (FIM2.0)(Baseline, 6 months and 12 months)
- Siblings perception measured by the Siblings Perception Questionnaire (SPQ)(Baseline, 6 months and 12 months)
- Quality of life measured by Pediatric Quality of Life (PedsQL)(Baseline, 6 months and 12 months)
- Self reported sick leave in parents(Baseline, 6 months and 12 months)
- Less stress induced telomere shortening(Baseline and 12 months)
- Anxiety and depression in parents of childhood cancer survivors measured by the Symptom Checklist (SCL)(Baseline, 6 months and 12 months)
- Anxiety and depression in siblings over 18 years of childhood cancer survivors measured by the Symptom Checklist (SCL)(Baseline, 6 months and 12 months)
- Anxiety and depression in childhood cancer survivors and their siblings i the age range 8 to 17 years measured by the Revised Child Anxiety and Depression Scale (RCADS)(Baseline, 6 months and 12 months)
研究者
Pernille Bidstrup
PhD, group leader
Danish Cancer Society