Quality of Life, Specific Needs and Satisfaction With Care After Treatment for Vulvar Cancer - a Prospective, Longitudinal Swedish Nationwide Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 153
- 试验地点
- 4
- 主要终点
- Global quality of life
研究概览
简要总结
The aim of this prospective, longitudinal Swedish multi-center study is to assess the quality of life, treatment-related morbidity, unmet needs and satisfaction with care after treatment for vulvar cancer, evaluated by a validated questionnaire.
详细描述
PRIMARY OBJECTIVES:
Information about:
- General and vulvar-cancer-specific quality of life before and after any treatment for newly diagnosed vulvar cancer
- Treatment-related morbidity after any treatment for newly diagnosed vulvar cancer
- Unmet needs of patients with newly diagnosed vulvar cancer
- Satisfaction with care after any treatment for newly diagnosed vulvar cancer in Sweden.
OUTLINE:
The study is planned as a prospective, longitudinal multi-centre study in Sweden. Since 2017, the treatment of vulvar cancer patients has been accredited to four tertiary referral university hospitals in Sweden; the Sahlgrenska University hospital in Gothenburg, the Linköping University hospital, the Skåne University hospital in Lund and the Karolinska University hospital in Stockholm.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Primary diagnosis of vulvar cancer, all stages, all planned treatments
- •Informed consent
排除标准
- •Disability to understand and complete the questionnaire due to language difficulties, severe psychiatric illness or dementia
结局指标
主要结局
Global quality of life
时间窗: 1 year after end of treatment
Measured by the European Organisation of Research and Treatment of Cancer (EORTC)-QLQ-C30-questionnaire. Measurement on a scale between 0-and 100. Higher values represent better quality of life. A change of at least 5-8 points is regarded as clinically significant.
Vulvar-cancer-specific quality of life
时间窗: 1 year after end of treatment
Measured by the EORTC-QLQ-VU34-questionnaire. Higher values represent higher quality of life.
次要结局
- Satisfaction with Care(3--4 months after end of treatment)
- Unmet needs(3-4 months after end of treatment.)
- Depression and anxiety(1 year after end of treatment.)
研究者
Diana Zach
MD, senior consultant
Karolinska University Hospital