Cognitive Impact Associated with Surgery for Gastric or Esophageal Cancer

Not yet recruiting

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

• Registration Number: NCT06687291
• Lead Sponsor: Karolinska Institutet

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-07
• Study Start: 2024-11-11
• Study First Submitted QC: 2024-11-12
• Last Update Submitted: 2024-11-12
• Study First Posted: 2024-11-13
• Last Update Posted: 2024-11-13
• Primary Completion: 2026-11-11
• Study Completion: 2027-11-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 130

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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.

Trial Locations

Locations (1)

Karolinska University Hospital Huddinge; 🇸🇪 Huddinge, Sweden