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

June 28, 2025 updated by: Maria Lampi, Karolinska Institutet

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Sweden
      • Huddinge, Sweden, 14157
        • Recruiting
        • Karolinska University Hospital, Huddinge
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of postoperative delirium
Time Frame: 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.
From enrollment to the follow up meeting after surgery, approximate 6 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preoperative depression
Time Frame: 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).
From enrollment to admission for surgery
Preoperative frailty
Time Frame: At admission for surgery
Frailty is a risk factor for post operative delirium. Frailty will be measured preoperatively with Clinical Frailty Scale (CFS-9).
At admission for surgery
Health-related quality of life
Time Frame: 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).
From enrollment to the follow up meeting after surgery, approximate 6 months.
Malnutrition
Time Frame: 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.
At admission for surgery
Sarcopenia
Time Frame: 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.
From enrollment to admission for surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients experience of Postoperative delirium
Time Frame: The interview takes place 2 weeks after follow up-meeting
All participants that suffered from POD will be invited to participate in an interview, with a maximum number of 25 participants. A semi-structured one-on-one interview with the aim to describe patient experiences of POD will be used. The semi-structured interview technique allows the interviewer to ask probing questions for clarification when necessary. An interview guide will be used to ensure covering issues such as cognition, memory loss, attention, awareness and orientation to the environment. The participant will be asked for participation at the follow-up meeting after surgery. The interview takes place 2 weeks after follow up-meeting after surgery at the location (or via that media) that best serve the participant. The interview will be recorded and transcribed, then analysed using qualitative content analysis with an inductive and latent approach.
The interview takes place 2 weeks after follow up-meeting

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Collaborators

Region Stockholm

Investigators

  • Principal Investigator: Maria Lampi, PhD, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2025

Primary Completion (Estimated)

November 11, 2026

Study Completion (Estimated)

November 11, 2027

Study Registration Dates

First Submitted

November 7, 2024

First Submitted That Met QC Criteria

November 12, 2024

First Posted (Actual)

November 13, 2024

Study Record Updates

Last Update Posted (Actual)

July 2, 2025

Last Update Submitted That Met QC Criteria

June 28, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ethical approval 2024-00971-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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