Cognitive Impact Associated With Surgery For Gastric Or Esophageal Cancer

NCT06687291 | Recruiting

• 1 other identifier: Ethical approval 2024-00971-01
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

postoperative delirium; gastroesophageal cancer; Frailty; Quality of life; Preoperative depression; Malnutrition; Sarcopenia; Chemobrain; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative delirium

  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.

  From enrollment to the follow up meeting after surgery, approximate 6 months.

Secondary Outcomes (5)

• 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

Other Outcomes (1)

• Patients experience of Postoperative delirium

  The interview takes place 2 weeks after follow up-meeting

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with esophageal or gastric cancer who will be treated with (or without) chemotherapy and surgery at Karolinska University Hospital in Huddinge (Sweden).

You may qualify if:

• Patients diagnosed with esophageal or gastric cancer, treated with (or without) chemotherapy and surgery.
• Participate on a voluntary basis and can (for any reason) end its participation during the study.
• Capable of giving informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator

Study Sites (1)

Karolinska University Hospital, Huddinge

Huddinge, 14157, Sweden

RECRUITING

Related Publications (4)

• Tieges Z, Maclullich AMJ, Anand A, Brookes C, Cassarino M, O'connor M, Ryan D, Saller T, Arora RC, Chang Y, Agarwal K, Taffet G, Quinn T, Shenkin SD, Galvin R. Diagnostic accuracy of the 4AT for delirium detection in older adults: systematic review and meta-analysis. Age Ageing. 2021 May 5;50(3):733-743. doi: 10.1093/ageing/afaa224.

  PMID: 33951145 BACKGROUND

• Liu J, Li J, Wang J, Zhang M, Han S, Du Y. Associated factors for postoperative delirium following major abdominal surgery: A systematic review and meta-analysis. Int J Geriatr Psychiatry. 2023 Jun;38(6):e5942. doi: 10.1002/gps.5942.

  PMID: 37260053 BACKGROUND

• Loh KP, Janelsins MC, Mohile SG, Holmes HM, Hsu T, Inouye SK, Karuturi MS, Kimmick GG, Lichtman SM, Magnuson A, Whitehead MI, Wong ML, Ahles TA. Chemotherapy-related cognitive impairment in older patients with cancer. J Geriatr Oncol. 2016 Jul;7(4):270-80. doi: 10.1016/j.jgo.2016.04.008. Epub 2016 Jul 5.

  PMID: 27197918 BACKGROUND

• Hughes CG, Boncyk CS, Culley DJ, Fleisher LA, Leung JM, McDonagh DL, Gan TJ, McEvoy MD, Miller TE; Perioperative Quality Initiative (POQI) 6 Workgroup. American Society for Enhanced Recovery and Perioperative Quality Initiative Joint Consensus Statement on Postoperative Delirium Prevention. Anesth Analg. 2020 Jun;130(6):1572-1590. doi: 10.1213/ANE.0000000000004641.

  PMID: 32022748 BACKGROUND

Related Links

• Cognitive test 4AT
• European Organisation for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQC-C30). Quality of life questionnaire for patients with cancer.
• European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Oesophago-Gastric cancer (QLQ-OG25) questionnaire. Quality of life questionnaire for patients with gastroesophageal cancer.
• Patient Health Questionnaire (PHQ-9), questionnaire about depression
• Clinical Frailty Scale (CFS-9). Frailty questionnaire
• Patient-Generated Subjective Global Assessment (PG-SGA). A validated tool for screening and assessing malnutrition

MeSH Terms

Conditions

Emergence Delirium; Frailty; Malnutrition; Sarcopenia; Chemotherapy-Related Cognitive Impairment; Depression

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Nutrition Disorders; Nutritional and Metabolic Diseases; Muscular Atrophy; Neuromuscular Manifestations; Atrophy; Pathological Conditions, Anatomical; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Cognitive Dysfunction; Cognition Disorders; Behavioral Symptoms; Behavior

Study Officials

• Maria Lampi, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcus Nömm, PhD-student

CONTACT

0733765652; marcus.nomm@ki.se

Maria Lampi, PhD

CONTACT

0852483721; maria.lampi@ki.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: November 13, 2024
• Study Start: February 13, 2025
• Primary Completion (Estimated): November 11, 2026
• Study Completion (Estimated): November 11, 2027
• Last Updated: July 2, 2025

Record last verified: 2025-06

Locations

SE (1)