Analysis of Anxiety-depressive Patterns, Quality of Life and Personality Assessment in Patients With Pancreatic Cancer: Outcome of Adaptation to Disease and Clinical Treatments
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Analysis of the anxiety and depression in patients who face active cancer treatment (chemotherapy, radiotherapy, surgery)
研究概览
简要总结
The aim of this study is the evaluation of psychological aspects, such as anxiety-depressive patterns, quality of life, personality and other psychopathological syndromes of patients who receive a diagnosis of pancreatic cancer and who face chemotherapy treatment, radio-chemotherapy or surgery
详细描述
Pancreatic cancer is an aggressive disease whose prognosis is generally unfavorable: less than 20% of patients results eligible for resection treatment with potentially curative purposes and only in 2019 in Italy 13,500 new cases were estimated. It represents one of the poorest prognosis with 8.1% survival at 5 years and 3% at 10 years.
Its treatments can have a negative effect on the quality of life linked to the health of patients (HRQoL). Over the past 20 years, the quality of life assessment has become an important component of evaluating new therapeutic approaches, providing indications on the patient's perception of the benefits of the treatments to which he undergoes. Therefore, an accurate assessment of HRQoL using valid and standardized tools is crucial to highlight the costs and benefits of the different therapeutic options and the clinical utility of the data.
Description of the intervention (schedule of visits):
Visit 1 (screening). Patients will be informed about the study. Once patients agree with the inclusion in the study the investigators will evaluate the inclusion and exclusion criteria. Those patients who meet all the inclusion criteria and none of the exclusion criteria will be finally included in the study. In this visit, patients, tumor-related variables, and general patients' features will be recorded, and all questionnaires will be administered EORTC QLQ 30, EORTC- PAN 26, HADS, Millon Clinical Multiaxial Inventory).
Enrolled patients will make a first psychological visit within one month of the initial diagnosis and before starting active medical treatment (chemotherapy, radiochemotherapy, surgery). During this visit, they will be asked to complete questionnaires aimed at assessing the quality of life (EORCT QLQ 30, EORCT PAN26) of the anxiety-depressant aspects related to the disease (HADS) and of the personological functioning (MCMI-III) to proceed psychological evaluation.
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
- •Patients older than 18 years
- •Patients candidated to receive an active treatment (surgery, chemiotherapy, chemio-radiation)
- •Patients able to sign the informed consent.
排除标准
- •• Patients with a school education level less than 8 years, since the complexity of submitted questionnaires.
结局指标
主要结局
Analysis of the anxiety and depression in patients who face active cancer treatment (chemotherapy, radiotherapy, surgery)
时间窗: 12 weeks after the diagnosis
The prevalence and variations of the anxious and depressive symptoms related to the disease condition (HADS questionnaire) during the disease course
Analysis of the quality of life in patients who face active cancer treatment (chemotherapy, radiotherapy, surgery)
时间窗: 12 weeks after the diagnosis
The quality of life self-perceived by the patient (EORTC QLQ 30 - PAN 26 questionnaires) and its variations during the disease path
次要结局
- The influence of patient personality on chemioterapic treatment response(12 weeks after the diagnosis)
研究者
Michele Reni
MD
IRCCS San Raffaele