Totally Implantable Venous Access Devices (TIVAD): Impact on Quality of Life and Body Image
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Generic and quality of life and body image
研究概览
简要总结
Our hypothesis is that totally Implantable Venous Access Devices in neoplastic patients modify body image and self-representation. Therefore, the purpose of this study is to evaluate the efficacy of psychological intervention on patients undergone this surgical practice.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •neoplastic patients
- •not visible demolitive interventions
- •not psychopathological diagnosis
- •language understanding
排除标准
- •not neoplastic patients
- •psychopathological diagnosis
- •language misunderstanding
研究组 & 干预措施
psychological support
Arm A will undergo psychological support and standard care prior and post TIVAD (Totally Implantable Venous Access Devices) insertion Arm B will undergo standard care prior and post TIVAD insertion
干预措施: psychological support (interactive/cognitive strategies) (Behavioral)
standard care
this arm does not receive psychological support before and after Totally Implantable Venous Access Devices positioning
结局指标
主要结局
Generic and quality of life and body image
时间窗: 15 days
EORTC (European Organization for Research and Treatment of Cancer) questionnaire: BR23 (Breast questionnaire, used just for BI scale, that is Body Image items)
次要结局
- Satisfaction with care(15 days)
研究者
Marco Scarpa
MD, PhD
Istituto Oncologico Veneto IRCCS