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临床试验/NCT07298980
NCT07298980Enrolling By Invitation不适用

Expressive Writing in Breast Cancer - The ExBRAC Trial

Region Skane1 个研究点 分布在 1 个国家目标入组 272 人开始时间: 2026年2月1日最近更新:
适应症
干预措施

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

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

Experimental

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

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

研究者

发起方
Region Skane
申办方类型
Other
责任方
Sponsor

研究点 (1)

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