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NCT04444544: ChangeQoL
Quality of Life and High-Risk Abdominal Cancer Surgery
trial testing High Risk Abdominal Surgery in Quality of Life in 295 participants. Status unknown.
30 June 2024
Quick facts
| Lead sponsor | University Hospital, Geneva |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 295 |
| Start date | 5 September 2020 |
| Primary completion | 30 June 2024 |
| Estimated completion | 30 December 2024 |
| Sites | 1 location across Switzerland |
Drugs / interventions tested
- High Risk Abdominal Surgery
Conditions studied
- Quality of Life — all drugs for Quality of Life →
- Surgery — all drugs for Surgery →
- Cancer — all drugs for Cancer →
- Frailty — all drugs for Frailty →
Sponsor
University Hospital, Geneva
Who can join
18 and older, any sex, with Quality of Life or Surgery. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Changes of health-related quality of life 6 months after high-risk oncological upper gastrointestinal and hepatobiliary surgery: a single-centre prospective observational study (<i>ChangeQol Study</i>).
Maillard J, Elia N, Ris F, Courvoisier DS, et al · · 2023 · cited 3× · PMID 36813502 · DOI 10.1136/bmjopen-2022-065902
Verify or expand the search:
- PubMed search for NCT04444544
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04444544 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Geneva
- Last refreshed: 1 March 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04444544.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing