Quality of Life and High-Risk Abdominal Cancer Surgery

  • STATUS
    Recruiting
  • End date
    Dec 30, 2022
  • participants needed
    266
  • sponsor
    University Hospital, Geneva
Updated on 15 June 2021
cancer surgery
primary cancer

Summary

The investigators plan to measure the changes of health-related quality of life (HRQoL) at 6 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 after the surgery. The investigators will identify phenotypes of HRQoL changes (improvement, stability and deterioration) at 6 months after surgery.

The second aim is to assess the regret of the patient at 6 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; assess the regret of the next of kin regarding the decision of the patient to undergo surgical oncology at 6 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 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 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.

Details
Condition Surgery, Cancer, Surgical aspects, Surgery, Quality of life, Frailty, primary cancer, primary malignant neoplasm, malignancy, cancers, malignancies, malignant tumor, malignant tumors, quality-of-life, surgical procedures, surgical treatment, surgeries, surgical procedure
Treatment High Risk Abdominal Surgery
Clinical Study IdentifierNCT04444544
SponsorUniversity Hospital, Geneva
Last Modified on15 June 2021

Eligibility

Yes No Not Sure

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)
Clear my responses

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