How patients' information and expectations affect outcomes after major abdominal cancer surgery
Evaluating Health Literacy, Expectations and Regrets in Patients Undergoing Major Abdominal Surgery for Malignant Disease
This project will see if patients' health literacy and preoperative expectations before major abdominal cancer surgery relate to their later feelings of regret and quality of recovery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 1 site (Copenhagen, Copenhagen) |
| Trial ID | NCT07450950 on ClinicalTrials.gov |
What this trial studies
This prospective observational cohort at Copenhagen University Hospital (Rigshospitalet) will enroll adults scheduled for elective major abdominal cancer surgeries, including pancreatic, hepatic, esophageal, gastric, and major colorectal procedures. Participants complete validated questionnaires on health literacy, preoperative information and expectations at baseline, then again about one month and three months after surgery to capture postoperative experiences, decision regret, and health-related quality of life. Investigators will correlate baseline literacy and expectation measures with postoperative regret and recovery metrics to identify patterns of unmet information needs. No investigational treatments are given; the study uses questionnaire data collected during routine care.
Who should consider this trial
Good fit: Adults (≥18) who can read Danish and are scheduled for elective major abdominal cancer surgery at Rigshospitalet are ideal candidates.
Not a fit: Patients who cannot read Danish, who are cognitively unable to complete questionnaires, or who undergo emergency surgery are unlikely to benefit from participating.
Why it matters
Potential benefit: If successful, the findings could help hospitals improve how they inform and support patients so fewer people experience unexpected outcomes or decision regret after major abdominal cancer surgery.
How similar studies have performed: Prior research has linked lower health literacy and unmet expectations to worse patient-reported outcomes and decision regret in surgical populations, but this study applies those ideas specifically to major abdominal cancer operations.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Copenhagen, Copenhagen
- Rigshospitalet — Copenhagen, Copenhagen, Denmark (Recruiting)
Study contacts
- Study coordinator: Amalie W. H. Westergaard, Medical student
- Email: amalie.winding.hjortshoej.westergaard@regionh.dk
- Phone: +4560528807
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.