ChangeQoL
Quality of Life and High-Risk Abdominal Cancer Surgery
Rekrutierend
NCT-Nummer:
NCT04444544
Studienbeginn:
September 2020
Letztes Update:
01.03.2023
Wirkstoff:
-
Indikation (Clinical Trials):
Frailty
Geschlecht:
Alle
Altersgruppe:
Erwachsene (18+)
Phase:
-
Sponsor:
University Hospital, Geneva
Collaborator:
-
Brief 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.
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)
Primary outcome:
1. Health-related Quality of Life (Time Frame - 6 months after surgery):
EORTC-QLQ C30. Minimum 0, Maximum 100
Secondary outcome:
1. Regret (Time Frame - 6 and 12 months after surgery):
Decision Regret Scale. Minimum 0, Maximum 100
2. Health-related Quality of Life (Time Frame - 12 months after surgery):
EORTC-QLQ C30. Minimum 0, Maximum 100
- High Risk Abdominal Surgery:
Pancreatectomy, Esophagectomy, Gastrectomy and Hepatectomy
Quelle: ClinicalTrials.gov
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