NCT01331629已完成2 期
Impact of Art Therapy on Fatigue and Quality of Life of Patients Treated With Adjuvant Radiotherapy for Breast Cancer
Centre Francois Baclesse12 个研究点 分布在 1 个国家目标入组 322 人开始时间: 2010年7月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 322
- 试验地点
- 12
- 主要终点
- evaluate persistent fatigue
研究概览
简要总结
The purpose of this study is to compare intervention by Art-therapy to standard care in patients treated with adjuvant radiotherapy for breast cancer and evaluate the fatigue.
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
- •Breast cancer surgery (invasive or in situ) by conservative surgery
- •Age ≥ 18 years
- •Indication of adjuvant radiotherapy
- •Adjuvant chemotherapy allowed
- •Agreeing to participate in a clinical study
- •Able to participate in a clinical trial
排除标准
- •Metastatic Breast Cancer
- •Personal history of breast cancer
结局指标
主要结局
evaluate persistent fatigue
时间窗: up to 12 months after radiotherapy
Estimate the decrease in the proportion of patients with persistent fatigue after one month of radiotherapy in patients receiving an approach from art therapy as a complement to standard care compared to those with care standard alone. Evaluated by auto-questionnary
次要结局
- Evaluate the quality of life patients.(up to 12 months after radiotherapy)
- Assess the impact of the condition of patients on the reactions, depression and anxiety of relatives Assess the impact of the condition of patients on the reactions, depression and anxiety of relatives(up to 12 months after radiotherapy)
- Evaluate the fatigue away from the treatment (at 6 months and 1 year) of patients(6 months and 12 months after treatment)
- Evaluate the anxiety of patients(up 12 months after radiotherapy)
- evaluate the depression of patients(up 12 months after study)
- Evaluate the quality of life away from the treatment (at 6 months and 1 year) of patients(6 months and 1 year after treatment)
研究者
研究点 (12)
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