Quality of LifeChangeQoLNCT04444544
Quality of Life and High-Risk Abdominal Cancer Surgery
An observational study of Quality of Life and Surgery, run by University Hospital, Geneva at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life, Surgery, Cancer
- What is being tested?
- High Risk Abdominal Surgery
- How many people
- 295 participants
- Where
- 1 siteSwitzerland
- Study dates
- 5 Sep 2020to 20 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Elective patients scheduled for high-risk abdominal cancer surgery
Who may be able to join
- Adult patients (>18 years) scheduled for the following elective abdominal cancer surgery known for high one-year mortality4: gastrectomy; esophagectomy; pancreas resection and hepatectomy
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read more
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.
Read the detailed description
The full protocol has been published: DOI 10.1136/bmjopen-2022-065902
- Conditions
- Quality of Life, Surgery, Cancer, Frailty
- Being tested
- High Risk Abdominal Surgery
- Keywords
- Quality of Life, Surgery, Regret
- Medical subject headings
- Neoplasms, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Risk Abdominal SurgeryOther
Pancreatectomy, Esophagectomy, Gastrectomy and Hepatectomy
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related Quality of Life
EORTC-QLQ C30. Minimum 0, Maximum 100
Measured: 6 months after surgery
Secondary outcomes (2)
Regret
Decision Regret Scale. Minimum 0, Maximum 100
Measured: 6 and 12 months after surgery
Health-related Quality of Life
EORTC-QLQ C30. Minimum 0, Maximum 100
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start5 Sep 2020
- Primary completion8 Dec 2024
- Study completion20 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 295 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julien Maillard, University Hospital, Geneva
- Investigators
- Bernhard Walder, MD, Study director, University Hospitals of Geneva - Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04444544
- Sponsor's protocol ID
- 2020-00536
- Acronym
- ChangeQoL
- Status last verified
- Apr 2026
- First submitted
- 12 Mar 2020
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Maillard J, Elia N, Ris F, Courvoisier DS, Zekry D, Labidi Galy I, Toso C, Monig S, Zaccaria I, Walder B. 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). BMJ Open. 2023 Feb 22;13(2):e065902. doi: 10.1136/bmjopen-2022-065902.
PubMed 36813502
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04444544
- Acronym / sponsor ID
- ChangeQoL / 2020-00536
- Conditions
- Quality of Life, Surgery, Cancer, Frailty
- Keywords
- Quality of Life, Surgery, Regret
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 295 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 5 Sep 2020 (actual)
- Primary completion
- 8 Dec 2024 (actual)
- Study completion
- 20 Jul 2025 (actual)
- First posted
- 23 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The full protocol has been published: DOI 10.1136/bmjopen-2022-065902
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Elective patients scheduled for high-risk abdominal cancer surgery
Key inclusion criteria (1 listed)
- Adult patients (>18 years) scheduled for the following elective abdominal cancer surgery known for high one-year mortality4: gastrectomy; esophagectomy; pancreas resection and hepatectomy
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Risk Abdominal SurgeryPancreatectomy, Esophagectomy, Gastrectomy and Hepatectomy | Other | – |
Primary outcome
Health-related Quality of Life
Time frame: 6 months after surgery
EORTC-QLQ C30. Minimum 0, Maximum 100
2 secondary outcomes
Regret
Time frame: 6 and 12 months after surgery
Health-related Quality of Life
Time frame: 12 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Derived from this study: PubMed 36813502Maillard J, Elia N, Ris F, Courvoisier DS, Zekry D, Labidi Galy I, Toso C, Monig S, Zaccaria I, Walder B. 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). BMJ Open. 2023 Feb 22;13(2):e065902. doi: 10.1136/bmjopen-2022-065902.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernhard Walder, MD study director
University Hospitals of Geneva - Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life and Surgery, run by University Hospital, Geneva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related Quality of Life (time frame: 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04444544, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.