Clinical trial NCT06687291: Cognitive Impact Associated with Surgery for Gastric or Esophageal Cancer
Official title: Cognitive Impact Associated with Surgery for Gastric or Esophageal Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
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
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2024-11-13
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of postoperative delirium
timeFrame: From enrollment to the follow up meeting after surgery, approximate 6 months.
Secondary outcomes:
measure: Preoperative depression
timeFrame: From enrollment to admission for surgery
measure: Preoperative frailty
timeFrame: At admission for surgery
measure: Health-related quality of life
timeFrame: From enrollment to the follow up meeting after surgery, approximate 6 months.
measure: Malnutrition
timeFrame: At admission for surgery
measure: Sarcopenia
timeFrame: From enrollment to admission for surgery
Other outcomes:
measure: Patients experience of Postoperative delirium
timeFrame: The interview takes place 2 weeks after follow up-meeting
Locations:
city: Huddinge
country: Sweden
facility: Karolinska University Hospital Huddinge
Study officials:
affiliation: Karolinska Institutet
name: Maria Lampi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.