Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:50 AM
Study NCT ID:
NCT07450950
Status:
RECRUITING
Last Update Posted:
2026-03-05
First Post:
2026-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating Health Literacy, Expectations and Regrets in Patients Undergoing Major Abdominal Surgery for Malignant Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017060', 'term': 'Patient Satisfaction'}], 'ancestors': [{'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-04', 'studyFirstSubmitDate': '2026-02-24', 'studyFirstSubmitQcDate': '2026-03-04', 'lastUpdatePostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative decision regrets', 'timeFrame': '1 month, and 3 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Preoperative anxiety and depression', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Quality of information', 'timeFrame': 'Perioperative', 'description': "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."}, {'measure': "Patients' preoperative expectations", 'timeFrame': 'Baseline', 'description': "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."}, {'measure': 'Health literacy', 'timeFrame': 'Baseline', 'description': "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."}, {'measure': 'Fulfillment of patient expectations', 'timeFrame': '1 month', 'description': '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.'}, {'measure': 'Health-related quality of life', 'timeFrame': 'Baseline, 1 month, and 3 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Health literacy', 'Patient expectations', 'Expectations', 'Decision', 'Regret', 'Quality of life', 'Major abdominal surgery', 'Pancreatic surgery', 'Hepatic surgery', 'Esophageal surgery', 'Gastric surgery', 'Prospective cohort study', 'Qualitative interviews', 'Patient satisfaction'], 'conditions': ['Surgery, Major Pancreatic', 'Surgery, Major Hepatic', 'Large Bowel/Sarcoma Resections', 'Surgery, Major Esophageal or Stomach']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': "Validation of a decision regret scale Jamie C Brehaut 1, Annette M O'Connor, Timothy J Wood, Thomas F Hack, Laura Siminoff, Elisa Gordon, Deb Feldman-Stewart PMID: 12926578 DOI: 10.1177/0272989X03256005"}, {'type': 'BACKGROUND', 'citation': 'Jensen MB, Jensen CE, Gudex C, Pedersen KM, Sørensen SS, Ehlers LH. Danish population health measured by the EQ-5D-5L. Scand J Public Health. marts 2023;51(2):241-9.'}, {'type': 'BACKGROUND', 'citation': 'Djukanovic I, Carlsson J, Årestedt 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;15(1):1-10.'}, {'type': 'BACKGROUND', 'citation': "Shedden-Mora MC, Alberts J, Petrie KJ, Laferton JAC, Von Blanckenburg P, Kohlmann S, m.fl. The Treatment Expectation Questionnaire (TEX-Q): Validation of a generic multidimensional scale measuring patients' treatment expectations. Abe T, redaktør. PLOS ONE. 23. januar 2023;18(1):e0280472."}, {'type': 'BACKGROUND', 'citation': 'Kong H, West S. WMA DECLARATION OF HELSINKI - ETHICAL PRINCIPLES FOR Scientic Requirements and Research Protocols. 2013;(June 1964):29-32.'}, {'type': 'BACKGROUND', 'citation': 'Hickmann E, Richter P, Schlieter H. All together now - patient engagement, patient empowerment, and associated terms in personal healthcare. BMC Health Serv Res. 2. september 2022;22(1):1116.'}, {'type': 'BACKGROUND', 'citation': 'Holden CE, Wagland R, Harle A, Wheelwright S. The experiences and decision making of patients with incurable cancer and health literacy difficulties. Babu N, redaktør. PLOS ONE. 3. oktober 2024;19(10):e0309104.'}, {'type': 'BACKGROUND', 'citation': 'Van Der Weijden T, Van Der Kraan J, Brand PLP, Van Veenendaal H, Drenthen T, Schoon Y, m.fl. Shared decision-making in the Netherlands: Progress is made, but not for all. Time to become inclusive to patients. Z Für Evidenz Fortbild Qual Im Gesundheitswesen. juni 2022;171:98-104.'}, {'type': 'BACKGROUND', 'citation': 'Becerra Pérez MM, Menear M, Brehaut JC, Légaré F. Extent and Predictors of Decision Regret about Health Care Decisions: A Systematic Review. Med Decis Making. august 2016;36(6):777-90'}, {'type': 'BACKGROUND', 'citation': 'Jumma W, Mohamed M, Joseph L, Canby G, Paungmali A, Sitilertpisan P. Are patient expectations associated with treatment outcomes in individuals with chronic low back pain ? A systematic review of randomised controlled trials. 2020;(August):1-18.'}, {'type': 'BACKGROUND', 'citation': 'Chichua M, Brivio E, Mazzoni D, Pravettoni G. Shared decision-making and the lessons learned about decision regret in cancer patients. Support Care Cancer. juni 2022;30(6):4587-90.'}, {'type': 'BACKGROUND', 'citation': 'Pel-Littel RE, Buurman BM, Minkman MM, Scholte Op Reimer WJM, Twisk JWR, Van Weert JCM. The influence of health literacy, anxiety and education on shared decision making and decisional conflict in older adults, and the mediating role of patient participation: A video observational study. Patient Educ Couns. juli 2024;124:108274.'}, {'type': 'BACKGROUND', 'citation': 'Muscat DM, Shepherd HL, Nutbeam D, Trevena L, McCaffery KJ. Health Literacy and Shared Decision-making: Exploring the Relationship to Enable Meaningful Patient Engagement in Healthcare. J Gen Intern Med. februar 2021;36(2):521-4.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/32472490/', 'label': 'Muscat DM, Shepherd HL, Nutbeam D, Trevena L, McCaffery KJ. Health Literacy and Shared Decision-making: Exploring the Relationship to Enable Meaningful Patient Engagement in Healthcare. J Gen Intern Med. februar 2021;36(2):521-4.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.', 'detailedDescription': '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.\n\nThe 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.\n\nThis 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.\n\nData 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who will undergo major surgery in the pancreas, liver, esophagus or stomach at Copenhagen University Hospital, Rigshospitalet', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients \\> 18 years undergoing elective surgical treatment.\n* Patients who can read and understand the Danish language.\n\nExclusion Criteria:\n\n\\- Patients who are cognitively disabled and cannot mentally cooperate with the study design, as assessed by the investigator.\n\nIn accordance with the Declaration of Helsinki, patients have the right to withdraw from the study at any time for any reason'}, 'identificationModule': {'nctId': 'NCT07450950', 'briefTitle': 'Evaluating Health Literacy, Expectations and Regrets in Patients Undergoing Major Abdominal Surgery for Malignant Disease', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Evaluating Health Literacy, Expectations and Regrets in Patients Undergoing Major Abdominal Surgery for Malignant Disease', 'orgStudyIdInfo': {'id': 'AW-regrets25'}}, 'armsInterventionsModule': {'armGroups': [{'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'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'state': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Amalie W. H. Westergaard, Medical student', 'role': 'CONTACT', 'email': 'amalie.winding.hjortshoej.westergaard@regionh.dk', 'phone': '+4560528807'}, {'name': 'Anja E. Geisler, Dr.Med.Sc.', 'role': 'CONTACT', 'email': 'Anja.Edith.Geisler@regionh.dk', 'phone': '+4523318446'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Nursing Research Manager, Senior Preacher/Associate Professor, Dr. med', 'investigatorFullName': 'Anja Edith Geisler', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}