Cognitive Impact Associated With Surgery For Gastric Or Esophageal Cancer

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKarolinska Institutet

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

130 Participants
are grouped into 2 trial groups
Group A: Participants identified with postoperative delirium
Group B: CASE-study participants

Trial outcomes

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.

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

Secondary outcomes

1

Preoperative depression

A risk factor for postoperative delirium is preoperative depression. Depression will be measured preoperatively with the Patient Health Questionnaire (PHQ-9).

Time frame
From enrollment to admission for surgery
2

Preoperative frailty

Frailty is a risk factor for post operative delirium. Frailty will be measured preoperatively with Clinical Frailty Scale (CFS-9).

Time frame
At admission for surgery
3

Health-related quality of life

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).

Time frame
From enrollment to the follow up meeting after surgery, approximate 6 months.
4

Malnutrition

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.

Time frame
At admission for surgery

Other outcomes

1

Patients experience of Postoperative delirium

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.

Time frame
The interview takes place 2 weeks after follow up-meeting

Sponsors and contacts

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Karolinska Institutet

Lead sponsor

Region Stockholm

Collaborator