NCT06212414招募中不适用
Mind Programme for Women With Breast Cancer: A Randomized Controlled Trial Testing the Programme´s Cost-effectiveness and Efficacy in Changing Psychological and Biological Outcomes (Nationwide Coverage)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 153
- 试验地点
- 2
- 主要终点
- Change from baseline cancer-specific quality of life at post-treatment and 6-month follow-up
研究概览
简要总结
The purpose of this research project is to optimize the Mind programme for women with breast cancer, taking into consideration the results from its pilot study, and to testits efficacy and cost-effectiveness through a 3-arm randomized controlled trial
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change from baseline cancer-specific quality of life at post-treatment and 6-month follow-up
时间窗: Baseline, post-treatment (2 months after baseline) and 6-month follow-up
EORTC QLQ-C30
次要结局
- Change from baseline health-related quality of life at post-treatment and 6-month follow-up(Baseline, post-treatment (2 months after baseline) and 6-month follow-up)
- Major life events - controlling variable(6-month follow-up)
- Change from baseline depressive symptoms and anxiety severity at post-treatment and 6-month follow-up(Baseline, post-treatment (2 months after baseline) and 6-month follow-up)
- Change from baseline psychological flexibility at post-treatment and 6-month follow-up(Baseline, post-treatment (2 months after baseline) and 6-month follow-up)
- Change from baseline self-compassion and mindfulness at post-treatment and 6-month follow-up(Baseline, post-treatment (2 months after baseline) and 6-month follow-up)
- Sociodemographic and clinical variables - controlling variables(Baseline)
- Change from baseline consumption of resources and costs in breast cancer at post-treatment and 6-month follow-up(Baseline, post-treatment (2 months after baseline) and 6-month follow-up)
研究者
Inês A Trindade
Principal investigator
University of Coimbra
研究点 (2)
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