Rigshospitalet
Copenhagen, 2100, Denmark
Location status: Recruiting
NCT Number: NCT07450950
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Copenhagen, 2100, Denmark
Location status: Recruiting
Patients undergoing major abdominal cancer surgery often face complex treatment decisions that involve weighing potential benefits against significant risks, including postoperative complications and prolonged recovery. In such situations, adequate patient information, realistic expectations and sufficient health literacy may be essential for supporting informed decision-making. When patients feel insufficiently informed or experience a mismatch between their expectations and postoperative outcomes, this may contribute to decision regret and reduced quality of life.
The purpose of this study is to explore the relationship between health literacy, preoperative information, patient expectations, and postoperative experiences in patients undergoing major abdominal cancer surgery. In particular, the study will examine how these factors relate to postoperative decision regret and health-related quality of life.
This is a prospective observational cohort study conducted at the Department of Transplantation and Digestive Diseases at Copenhagen University Hospital, Rigshospitalet, Denmark. Patients undergoing major abdominal cancer surgery, including pancreatic, hepatic, esophageal, gastric, and major colorectal procedures, will be invited to participate.
Data will be collected at baseline before surgery and at follow-up approximately one month and three months after surgery. Participants will complete validated questionnaires about health literacy, treatment expectations, perceived information received before surgery, anxiety and depression, decision regret and health-related quality of life. In addition, a subgroup of participants will be invited to participate in semi-structured qualitative interviews to explore how their preoperative expectations correspond with their postoperative experiences.
The study aims to improve understanding of how patient-related factors such as health literacy and expectations influence postoperative experiences and decision regret. The findings may contribute to a better understanding of factors associated with postoperative decision regret and patient-reported outcomes following major abdominal cancer surgery.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
In accordance with the Declaration of Helsinki, patients have the right to withdraw from the study at any time for any reason
Time frame: 1 month, and 3 months
Decision regret will be measured using the Danish version of the Decision Regret Scale (DRS). The scale consists of 5 items assessing the degree of regret following the surgical decision. Each item is rated on a 5-point scale, and the total score is transformed to a 0-100 scale, where 0 indicates no regret and 100 indicates high regret.
Time frame: Baseline
Anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale (HADS). The questionnaire contains 14 questions divided into two subgroups (anxiety and depression). Therefore there are 7 questions for each and is scored from 0 to 3 resulting in a total score ranging from 0 to 21 for each subgroup. Higher scores indicate higher levels of anxiety or depression.
Time frame: Perioperative
Patients' satisfaction with the information provided before surgery will be measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Information Module (EORTC QLQ-INFO25). The instrument assesses perceived information received about disease, medical tests, treatment, and other services. Scores range from 0 to 100, with higher scores indicating higher satisfaction with information.
Time frame: Baseline
Patients' preoperative expectations evaluated by The Treatment Expectation Questionnaire (TEX-Q). The questionnaire contains 15 questions where the patient can rate their expectations from 0 to 10. 0 indicates their expectations of no relief, no benefit or no improvement, whereas 10 represents the opposite.
Time frame: Baseline
Health literacy will be measured using the Brief Health Literacy Scale, which evaluates patients' ability to understand and use health-related information. Higher scores indicate higher levels of health literacy.
Time frame: 1 month
Fulfillment of preoperative expectations will be explored 14-30 days after surgery using a short semi-structured interview. Patients will be asked to reflect on how their expectations compared to their actual postoperative experiences.
Time frame: Baseline, 1 month, and 3 months
Health-related quality of life will be measured using EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L), which includes five domains: mobility, personal care, activities, pain/discomfort, and anxiety/depression. Each area has five response levels ranging from "no problems" to "extreme problems." In addition, patients will rate their overall health on a visual analog scale (VAS) from 0 (worst imaginable health) to 100 (best imaginable health). The patient will mark on the number indicating the self-evaluated health.
Contact information is provided by the study sponsor or research team.
Amalie W. H. Westergaard, Medical student
CONTACT
Anja E. Geisler, Dr.Med.Sc.
CONTACT
Rigshospitalet, Denmark
Other
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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