Chemobrain, Chemotherapy, Depression, Frailty, Gastroesophageal Cancer (GC), Malnutrition, Postoperative Delirium (POD), Quality of Life (QOL), Sarcopenia
Conditions
Keywords
postoperative delirium, gastroesophageal cancer, Frailty, Quality of life, Preoperative depression, Malnutrition, Sarcopenia, Chemobrain, Chemotherapy
Brief summary
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.
Interventions
None listed
Sponsors
Karolinska Institutet
Region Stockholm
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of postoperative delirium | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health-related quality of life | From enrollment to the follow up meeting after surgery, approximate 6 months. | Low score in quality of life is a risk factor for delirium. Patients will report health-related quality of life using the validated European Organisation for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQC-C30) and EORTC validated Quality of Life Questionnaire for Oesophago-Gastric cancer (QLQ-OG25). |
| Malnutrition | At admission for surgery | Patients with malnutrition before surgery have a higher risk of developing post-operative delirium. Malnutrition is assessed by using Patient-Generated Subjective Global Assessment (PG-SGA) before surgery. |
| Sarcopenia | From enrollment to admission for surgery | There is association between preoperative sarcopenia and postoperative delirium in patients undergoing gastrointestinal cancer surgery. Sarcopenia is assessed by using CT-scan in clinical routine. |
| Preoperative depression | From enrollment to admission for surgery | A risk factor for postoperative delirium is preoperative depression. Depression will be measured preoperatively with the Patient Health Questionnaire (PHQ-9). |
| Preoperative frailty | At admission for surgery | Frailty is a risk factor for post operative delirium. Frailty will be measured preoperatively with Clinical Frailty Scale (CFS-9). |
Countries
Sweden
Contacts
CONTACTMarcus Nömm, PhD-student
CONTACTMaria Lampi, PhD
PRINCIPAL_INVESTIGATORMaria Lampi, PhD
Karolinska Institutet
Outcome results
None listed