Expressive Writing in Breast Cancer - The ExBRAC Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Region Skane
- 入组人数
- 272
- 试验地点
- 1
- 主要终点
- Health-related quality of life
研究概览
简要总结
The study is a randomized trial designed to examine whether an "expressive writing" intervention can affect the quality of life in patients recently diagnosed with breast cancer. The method "expressive writing" consists of writing about the breast cancer or other related subjects during 20 minutes, once a week for four consecutive weeks. The impact on quality of life will be assessed by having participants complete questionnaires at three different time points during the study. The questionnaire will be developed using a clinimetric approach, based on semi-structured interviews with breast cancer patients. The themes emerging from these interviews will be used to formulate the questions. Additionally, well-known quality-of-life measurement instruments and registry data with clinically relevant information-such as tumor stage and treatment-will be incorporated.
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
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Planned for surgery of breast cancer without neoadjuvant treatment
排除标准
- •Not able to understand Swedish
- •Previous breast cancer
研究组 & 干预措施
Expressive Writing
Expressive writing for 20 minutes, once a week, for 4 consecutive weeks. The intervention is done in addition to standard care.
干预措施: Expressive Writing (Behavioral)
Control group
No intervention. Treatment according to standard care.
结局指标
主要结局
Health-related quality of life
时间窗: At the 12 months follow-up
According to EQ-5D-5L VAS. The scale ranges from 0-100 where 0 is "worst possible health" and 100 is "best possible health".
Health-related quality of life
时间窗: At the 12 months follow-up
According to EQ-5D-5L VAS. The scale ranges from 0-100 where 0 is "worst possible health" and 100 is "best possible health".
次要结局
未报告次要终点
