Clinical trial · Observational
Evaluating Health Literacy, Expectations and Regrets in Patients Undergoing Major Abdominal Surgery for Malignant Disease
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Patients undergoing major abdominal surgery often have to make complex decisions about their treatment, where risks, benefits and possible complications must be considered. Limited health literacy and unmet expectations can make this process difficult and may increase the risk of regret after surgery, as well as feelings of not having received sufficient support or clear information. The aim of this study is to explore how well patients understand the information they receive before surgery, what expectations they have and how these expectations relate to their postoperative experiences. The study includes patients undergoing major abdominal cancer surgery, such as pancreatic, liver, esophageal, gastric, or large bowel surgery, at Copenhagen University Hospital, Rigshospitalet. Data will be collected before surgery, one month after discharge and again three months later.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Large Bowel/Sarcoma Resections | — | UNRESOLVED | — |
| Surgery, Major Esophageal or Stomach | — | UNRESOLVED | — |
| Surgery, Major Hepatic | — | UNRESOLVED | — |
| Surgery, Major Pancreatic | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (4)
- label
- Surgery, major pancreatic
- description
- Whipples resection, total pancreatectomy or distal pancreatectomy
- label
- Surgery, major hepatic
- description
- Hilar cholangiocarcinoma, major liver resection (3 segments or more)
- label
- Large bowel/sarcoma resections
- label
- Surgery, major esophageal or stomach
- description
- Ivor Lewis esophagectomy, total or subtotal gastrectomy
Primary outcomes (1)
- measure
- Postoperative decision regrets
- timeFrame
- 1 month, and 3 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients \> 18 years undergoing elective surgical treatment. * Patients who can read and understand the Danish language. Exclusion Criteria: \- Patients who are cognitively disabled and cannot mentally cooperate with the study design, as assessed by the investigator. In accordance with the Declaration of Helsinki, patients have the right to withdraw from the study at any time for any reason
References
Publications (13)
- BACKGROUNDBrehaut JC, O'Connor AM, Wood TJ, Hack TF, Siminoff L, Gordon E, Feldman-Stewart D. Validation of a decision regret scale. Med Decis Making. 2003 Jul-Aug;23(4):281-92. doi: 10.1177/0272989X03256005. PMID 12926578
- BACKGROUNDJensen MB, Jensen CE, Gudex C, Pedersen KM, Sorensen SS, Ehlers LH. Danish population health measured by the EQ-5D-5L. Scand J Public Health. 2023 Mar;51(2):241-249. doi: 10.1177/14034948211058060. Epub 2021 Nov 30. PMID 34847818
- BACKGROUNDDjukanovic I, Carlsson J, Arestedt K. Is the Hospital Anxiety and Depression Scale (HADS) a valid measure in a general population 65-80 years old? A psychometric evaluation study. Health Qual Life Outcomes. 2017 Oct 4;15(1):193. doi: 10.1186/s12955-017-0759-9. PMID 28978356
- BACKGROUNDShedden-Mora MC, Alberts J, Petrie KJ, Laferton JAC, von Blanckenburg P, Kohlmann S, Nestoriuc Y, Lowe B. The Treatment Expectation Questionnaire (TEX-Q): Validation of a generic multidimensional scale measuring patients' treatment expectations. PLoS One. 2023 Jan 23;18(1):e0280472. doi: 10.1371/journal.pone.0280472. eCollection 2023. PMID 36689398
- BACKGROUNDKong H, West S. WMA DECLARATION OF HELSINKI - ETHICAL PRINCIPLES FOR Scientic Requirements and Research Protocols. 2013;(June 1964):29-32.
- BACKGROUNDHickmann E, Richter P, Schlieter H. All together now - patient engagement, patient empowerment, and associated terms in personal healthcare. BMC Health Serv Res. 2022 Sep 2;22(1):1116. doi: 10.1186/s12913-022-08501-5. PMID 36056354
- BACKGROUNDHolden CE, Wagland R, Harle A, Wheelwright S. The experiences and decision making of patients with incurable cancer and health literacy difficulties. PLoS One. 2024 Oct 3;19(10):e0309104. doi: 10.1371/journal.pone.0309104. eCollection 2024. PMID 39361567