Impact of a Family-oriented Rehabilitation Programme for Mothers With Breast Cancer and Their Children - Quality of Life and Psychological Health of Mothers and Their Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 801
- 试验地点
- 2
- 主要终点
- Mothers' and children's Quality of Life (EORTC OLQ-C30, QLQ-BR23; ILK)
研究概览
简要总结
About 1/3 of newly diagnosed breast cancer patients are mothers of children who still live at home. They face additional challenges and stress, their children are also affected by the mother's illness. The oncological rehabilitation programme "getting better together" focuses on these special family needs. This waiting-control-group study examines the effectiveness of the intervention by accompanying the patients and their children over the course of a year and assessing their quality of life and psychological health.
详细描述
About 1/3 of newly diagnosed breast cancer patients are mothers of children who still live at home. They face additional challenges and stress, their children are also affected by the mother's illness. The oncological rehabilitation programme "getting better together", administered by the Rexrodt von Fircks Foundation and the Clinic Ostseedeich in Groemitz, Germany, focuses on these special family needs. This waiting-control-group-study, designed and executed at the Philipps University Marburg Medical Center, Department of Child and Adolescent Psychiatry, examines the effectiveness of the intervention by accompanying the patients and their children over the course of a year and assessing their quality of life and psychological health.
The primary outcome measure for mothers is the health related quality of life as assessed by the EORTC QLQ-C30 and BR-23; children's adaptation is assessed with the ILK (Inventory for the Assessment of Quality of Life of Children and Adolescents) as well as the Strengths and Difficulties Questionnaire (SDQ)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •participants of the rehabilitation programme "getting better together"
- •mothers of children up to the age of 16
- •have been diagnosed with and treated for breast cancer for the first time in their lives
- •chemotherapy or radiation therapy ended no less than 6 weeks ago
排除标准
- •metastases
研究组 & 干预措施
3-week family oriented rehabprogramme
waiting control group
干预措施: rehabilitation programme "getting better together" (Behavioral)
结局指标
主要结局
Mothers' and children's Quality of Life (EORTC OLQ-C30, QLQ-BR23; ILK)
时间窗: 4 weeks before, at the beginning & post treatment, 3 and 12 months follow-up
次要结局
- Mothers' Depressive Symptoms (BDI)(4 weeks before, at the beginning and post treatment, 3 and 12 months follow up)
- Mothers' and children's Treatment Satisfaction(Post Treatment)
- Children's psychological difficulties (SDQ)(4 weeks before, at the beginning & post treatment, 3 and 12 months follow-up)
- Mother's Life Satisfaction(4 weeks before, at the beginning & post treatment, 3 and 12 months follow up)