Cognitive Impact Associated With Surgery For Gastric Or Esophageal Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-13

Study Completion Date

2027-11-11

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No