Cognitive Impact Associated With Surgery For Gastric Or Esophageal Cancer (CASE)

Karolinska Institute

Status: Enrolling

Conditions: Postoperative Delirium (POD); Chemotherapy; Malnutrition; Gastroesophageal Cancer (GC); Quality of Life (QOL); Depression; Frailty; Sarcopenia; Chemobrain

Study type: Observational

Funder types: Other

Identifiers

NCT06687291

Ethical approval 2024-00971-01

Details and patient eligibility

About

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.

Enrollment: 130 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

130 participants in 2 patient groups

Participants identified with postoperative delirium

Description:

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

Description:

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.