Cognitive Impact Associated With Surgery For Gastric Or Esophageal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Incidence of postoperative delirium
研究概览
简要总结
The primary objective of this observational study is to investigate the incidence of Post Operative Delirium (POD) after gastroesophageal cancer surgery. Secondary objectives are to investigate the relationship between POD, preoperative depression, frailty, quality of life, malnutrition and sarcopenia.
Participants identified with POD will be asked (at the routine follow-up meeting after surgery) to participate in an qualitative interview, in order to understand the participant's experience of postoperative delirium.
The main objective aims to answer:
What is the incidence of POD after gastroesophageal cancer surgery.
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 diagnosed with esophageal or gastric cancer, treated with (or without) chemotherapy and surgery.
- •Age ≥18 at the time for inclusion.
- •Participate on a voluntary basis and can (for any reason) end its participation during the study.
- •Capable of giving informed consent.
排除标准
- •Patients with preoperative cognitive dysfunction such as dementia.
- •Patients who are inoperable due to metastases.
- •Patients unable to communicate due to severely impaired hearing and/or - seeing.
- •Patients with ongoing drug and/or alcohol abuse.
- •Patients who cannot give informed consent.
研究组 & 干预措施
Participants identified with postoperative delirium
Participants identified with postoperative delirium will be asked (at the routine follow-up meeting after surgery) to participate in an qualitative interview in order to understand the participant's experience of postoperative delirium.
CASE-study participants
All included participants in the CASE-study.
- The assessment of cognitive function will be performed using the validated 4AT Test (4AT). Cognitive impact will be assessed at baseline before neoadjuvant chemotherapy (if chemotherapy is indicated) and at patient admission for surgery, postoperative day 1, 3 and 7, and at follow-up 4-8 weeks after surgery.
- Risk factors for POD will be explored by investigate the relationship between postoperative delirium, chemotherapy preoperative depression, frailty, quality of life, malnutrition and sarcopenia. Patients will report health-related quality of life using the validated EORTC QLQC-C30 and EORTC QLQ-OG25 questionnaires. Frailty and depression will be measured preoperatively with Clinical Frailty Scale (CFS-9) and the Patient Health Questionnaire (PHQ-9). Malnutrition is evaluated by using Patient-Generated Subjective Global Assessment (PG-SGA). Sarcopenia is assessed through CT-scan, which is conducted as part of clinical routine.
结局指标
主要结局
Incidence of postoperative delirium
时间窗: From enrollment to the follow up meeting after surgery, approximate 6 months.
The assessment of cognitive function will be performed using the validated 4AT Test (4AT). Cognitive impact will be assessed at baseline before neoadjuvant chemotherapy (if chemotherapy is indicated) and at patient admission for surgery, postoperative day 1, 3 and 7, and at follow-up 4-8 weeks after surgery.
次要结局
- Preoperative depression(From enrollment to admission for surgery)
- Preoperative frailty(At admission for surgery)
- Health-related quality of life(From enrollment to the follow up meeting after surgery, approximate 6 months.)
- Malnutrition(At admission for surgery)
- Sarcopenia(From enrollment to admission for surgery)
研究者
Maria Lampi
Principal Investigator
Karolinska Institutet