Cognitive Impact Associated With Surgery For Gastric Or Esophageal Cancer

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Sweden
Karolinska University Hospital, Huddinge
RECRUITING
Huddinge
Contact Information
Primary
Marcus Nömm, PhD-student
marcus.nomm@ki.se
0733765652
Backup
Maria Lampi, PhD
maria.lampi@ki.se
0852483721
Time Frame
Start Date: 2025-02-13
Estimated Completion Date: 2027-11-11
Participants
Target number of participants: 130
Treatments
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.
Sponsors
Leads: Karolinska Institutet
Collaborators: Region Stockholm

This content was sourced from clinicaltrials.gov