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Completed

NCT Number: NCT04444544

Quality of Life and High-Risk Abdominal Cancer Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals of Geneva

Geneva, 1206, Switzerland

About this study

The full protocol has been published: DOI 10.1136/bmjopen-2022-065902

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

High Risk Abdominal Surgery

Other

Pancreatectomy, Esophagectomy, Gastrectomy and Hepatectomy

Primary outcomes

  1. Health-related Quality of Life

    Time frame: 6 months after surgery

    EORTC-QLQ C30. Minimum 0, Maximum 100

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Official study 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)

Acronym: ChangeQoL

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Jun 23, 2020
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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