Health Related Quality of Life (HRQoL) in Patients With Solid Tumors Treated With Hadrontherapy (HadroQoL).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- investigate relation between quality of life and several socio- psycho- variables
研究概览
简要总结
The Quality of Life of patients treated with hadrontherapy is still limited. Two cohorts are established, they will be receiving specific standardized questionnaires to be evalutaed in their results.
详细描述
Since 2011, CNAO has been treating patients suffering from solid tumors with particle therapy (both protons and carbon ions). Hadrontherapy improves outcome of radioresistant tumors which normally do not benefit from conventional radiotherapy. The treated population is highly heterogenous in term of tumor site, histotype, treatment fields and doses however its common anatomical origin justifies a unified approach in evaluating a QoL in this setting. QoL of patients suffering from these tumors have been poorly investigated and there are still few studies on patient reported outcomes (PROs) and QoL following hadrontherapy. In this context, therefore, there is a need to generate data by designing distinct cohort studies, conceived within a single protocol, that will gather quality of life data by means of standardized questionnaires of patients along their oncological history. Thanks to this protocol design, the investigator will be facilitated, in the future, in adding new cohorts pending a study protocol amendment and ethical approval.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Histological and/or radiological diagnosis of head and neck tumors
- •Patients candidate for curative intent hadrontherapy
- •Patients ≥ 18 years of age
- •The patient is able to give consent
- •Exclusion criteria:
- •Re-irradiation.
- •Second tumor
- •Known cases of any psychiatric and neurological diseases leading to disability (eg, manic disorder, schizophrenia etc..), which could impair compilation of questionnaires or affect quality of life
- •Presence of diffused metastasis
排除标准
- 未提供
结局指标
主要结局
investigate relation between quality of life and several socio- psycho- variables
时间窗: 5 years follow uo after hadrontherapy
quality of life in subjects treated with curative hadrontherapy investigated by global score according to Short-form-12-health-survey-questionnaire (SF-12) and compared to healthy population
次要结局
- quality of life related also to psychological variables, socio-cognitive factors, resilience(before treatment and after 1 year from treatment completion)