Quality of Life and High-Risk Abdominal Cancer Surgery

Cancer Clinical Trial

— ChangeQoL  

Official title:

Changes of Health-related Quality of Life 6 Months After High-risk Oncological Upper Gastrointestinal and Hepatobiliary Surgery: a Single-centre Prospective Observational Study (ChangeQol Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04444544
• Other study ID #: 2020-00536
• Status: Recruiting
• Start date: September 5, 2020
• Est. completion date: December 30, 2024

Study information

• Verified date: February 2023
• Source: University Hospital, Geneva
• Contact: Julien Maillard, MD
• Phone: 0041787753730
• Email: julien.maillard[@]hcuge.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The investigators plan to measure the changes of health-related quality of life (HRQoL) at 6 months and 12 months after the following high-risk oncological abdominal surgery: gastrectomy, esophagectomy, pancreatectomy and hepatectomy. The investigators will measure the HRQoL using the validated EORTC QLQ-C30 questionnaire before and at 6 months and 12 month after the surgery. The investigators will identify phenotypes of HRQoL changes (improvement, stability and deterioration) at 6 months and 12 months after surgery.

The second aim is to assess the regret of the patient at 6 months and 12 months regarding his/her decision to undergo surgery. The investigators will also assess the regret of the next of kin at 6 months regarding the decision to undergo surgery.

This descriptive, prospective, observational, single-centre cohort study aims to: identify phenotypes of HRQoL changes after abdominal surgical oncology (improvement, stability and deterioration); assess the regret of patients regarding their decision to undergo surgical oncology at 6 months and 12 months; assess the regret of the next of kin regarding the decision of the patient to undergo surgical oncology at 6 months and 12 months. The investigators will include patients scheduled for the following elective abdominal cancer surgery: gastrectomy; esophagectomy; pancreas resection and hepatectomy. The investigators will assess HRQoL using the validated EORTC QLQ-C30 Summary Score before and 6 months and 12 months after surgery. The cut-offs for the three phenotypes of HRQoL changes will be defined using the minimal clinically important difference (MCID) of 10 points. The investigators will assess regret using the Decision Regret Scale (DRS) at 6 months and 12 months after surgery.

The expected results are: The investigators can identify phenotypes of HRQoL changes after surgical oncology using the EORTC QLQ-C30 Summary Score; the investigators will describe the distribution of these phenotypes and will find an association with the pre-existing frailty. The investigators can describe the extent of the regret of the patient and of the next of kin at 6 months using the DRS. The investigators will observe an association between the DRS score at 6 months and the HRQoL Summary Score change. The investigators will not observe a relationship between the DRS score of patients and next-of-kins.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 295
• Est. completion date: December 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients (>18 years) scheduled for the following elective abdominal cancer surgery known for high one-year mortality4: gastrectomy; esophagectomy; pancreas resection and hepatectomy

Exclusion Criteria:

• Patients with inoperable tumours; i.e. some patients will be excluded at the time of surgery if unexpected advanced tumour staging is confirmed intraoperatively (e.g. peritoneal carcinomatosis or any other diagnosis without therapy).

• Hepatectomy for metastasectomy

• Mentally impaired patients (known diagnosis)

• Psychotic diagnoses (i.e. schizophrenia)

• Dementia (mini mental score (MMSE) < 18)

• Incapacity to understand the information sheet

• Blindness (unable to perform the visual part of the mini-mental state examination)

Related Conditions & MeSH terms

• Cancer
• Frailty
• Quality of Life
• Surgery

Intervention

Other:
• High Risk Abdominal Surgery
Pancreatectomy, Esophagectomy, Gastrectomy and Hepatectomy

Locations

Country	Name	City	State
Switzerland	University Hospitals of Geneva	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health-related Quality of Life	EORTC-QLQ C30. Minimum 0, Maximum 100	6 months after surgery
Secondary	Regret	Decision Regret Scale. Minimum 0, Maximum 100	6 and 12 months after surgery
Secondary	Health-related Quality of Life	EORTC-QLQ C30. Minimum 0, Maximum 100	12 months after surgery