Evaluating Health Literacy, Expectations and Regrets in Patients Undergoing Major Abdominal Surgery for Malignant Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Surgery, Major Pancreatic, Surgery, Major Hepatic, Large Bowel/Sarcoma Resections, Surgery, Major Esophageal or Stomach. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed description
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.
Primary outcome measures
- Postoperative decision regrets [Time frame: 1 month, and 3 months]
Secondary outcome measures (6)
- Preoperative anxiety and depression [Time frame: Baseline]
- Quality of information [Time frame: Perioperative]
- Patients' preoperative expectations [Time frame: Baseline]
- Health literacy [Time frame: Baseline]
- Fulfillment of patient expectations [Time frame: 1 month]
- Health-related quality of life [Time frame: Baseline, 1 month, and 3 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Denmark · 1 center
- Rigshospitalet — Copenhagen
Publications
- Brehaut 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
- Jensen 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
- Djukanovic 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
- Shedden-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
- Kong H, West S. WMA DECLARATION OF HELSINKI - ETHICAL PRINCIPLES FOR Scientic Requirements and Research Protocols. 2013;(June 1964):29-32.
- Hickmann 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
- Holden 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
- van der Weijden T, van der Kraan J, Brand PLP, van Veenendaal H, Drenthen T, Schoon Y, Tuyn E, van der Weele G, Stalmeier P, Damman OC, Stiggelbout A. Shared decision-making in the Netherlands: Progress is made, but not for all. Time to become inclusive to patients. Z Evid Fortbild Qual Gesundhwes. 2022 Jun;171:98-104. doi: 10.1016/j.zefq.2022.04.029. Epub 2022 May 23. PMID 35613990
Identifiers
NCT: NCT07450950 · AW-regrets25