Support Pathway for ENT Cancer Patients in a Support Care Day Hospital Single-centre Prospective Randomised Interventional Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Anxiety
研究概览
简要总结
Cancers of the upper respiratory / digestive tract are a major public health problem, ranking 5th among the most common cancers. Surgery plays a central role in the recommended treatments for this type of pathology. The surgical procedure and its after-effects can be anxiety-provoking and have a major psychological, physical and social impact on patients over the long term.
Our institution's standard protocol is based on a pre-operative supportive care day hospital. The aim of this study is to compare our current care pathway with a more extensive interdisciplinary care pathway focused on patients' needs, in order to reduce anxiety and improve the quality of life of patients undergoing surgery for cancers of the upper respiratory / digestive tract.
Our aim is to use a prospective single-centre interventional study to assess the impact of adding three post-operative day hospitals to the existing care pathway in terms of reducing anxiety and improving the quality of life of patients undergoing surgery.
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
- All
- 接受健康志愿者
- 否
入选标准
- •patient undergoing surgery for VADS cancer requiring at least one night's post-operative hospitalisation
- •Understanding of spoken and written French
- •Patient covered by a social security scheme
排除标准
- •Protected patient under a protective measure or legal safeguard
- •Pregnant or breast-feeding patients
- •Patients suffering from major cognitive disorders
- •Patients with major anxiety disorders prior to the onset of cancer
研究组 & 干预措施
Control
Supportive care
干预措施: Consultations with paramedics (Procedure)
结局指标
主要结局
Anxiety
时间窗: 1 month ; 3 months ; 6 months
Anxiety evaluation by State Trait Anxiety Inventory (STAI) scale. It is a psychological inventory consisting of 40 self-report items on a 4-point Likert scale. The STAI measures two types of anxiety - state anxiety and trait anxiety. Higher scores are positively correlated with higher levels of anxiety.
次要结局
- Quality of life evaluation(1 month ; 3 months ; 6 months)
- pain evaluation(1 month ; 3 months ; 6 months)
- Toxic behaviour (tobacco and alcohol) evaluation(1 month ; 3 months ; 6 months)
- Weight status evaluation(1 month ; 3 months ; 6 months)
- nutritional status evaluation(1 month ; 3 months ; 6 months)
- swallowing assessment(1 month ; 3 months ; 6 months)
- vocal status assessment(1 month ; 3 months ; 6 months)