Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 3:55 AM
Study NCT ID:
NCT07481994
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-03-19
First Post:
2026-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Changes in Value-Based Assessment in Patients Undergoing Major Oncological Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-10-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-12-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-15', 'studyFirstSubmitDate': '2026-03-15', 'studyFirstSubmitQcDate': '2026-03-15', 'lastUpdatePostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-11-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Understanding of illness', 'timeFrame': 'one week before surgery', 'description': '1. What do you know about your health condition?\n2. How do you understand it?'}, {'measure': 'Identification of a close person', 'timeFrame': 'one week before surgery', 'description': '* With whom do you discuss important life matters?\n* Who could think or decide for you?'}, {'measure': 'Patient values and preferences', 'timeFrame': 'one week before surgery', 'description': 'What is important to you in life? Besides the surgery, what else do you think about?'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['senior'], 'conditions': ['Senior', 'Oncologic Disease']}, 'descriptionModule': {'briefSummary': "Introduction The study focuses on analyzing the level of awareness among oncological patients, their perception of their health status, and expectations regarding radical surgical intervention. It assesses changes in patients' attitudes toward their diagnosis, therapeutic options, and prognosis both preoperatively and postoperatively. The research involves a systematic collection of value-based medical history through structured interviews, enabling the identification of key factors influencing patient experience and decision-making processes in oncological treatment.", 'detailedDescription': "The study is particularly focused on collecting patients' value-based medical history before and immediately after surgery. Respondents must meet specific inclusion criteria to undergo surgical procedures classified as BUPA D-hemicolectomy, rectal resection, urological surgery (cystectomy or radical nephrectomy), or resection of malignant brain tumors. Patients scheduled for surgical intervention initially underwent an assessment in the anesthesiology clinic, where they were informed about the possibility of participating in the study. Upon signing the informed consent, the collection of their value-based medical history commenced. Following surgery and prior to discharge from the intensive care unit (ICU), a subsequent interview was conducted, during which responses were compared and potential changes in personal attitudes were evaluated \\[1,2, 3\\].\n\nThe value-based medical history was obtained following a predefined set of questions. The aim of the study is to determine whether collecting value-based medical history reveals patients' level of awareness regarding their illness, their expectations, and any shifts in attitudes after surgery and hospitalization in the ICU at ARIM KNTB Zlín. The findings may indicate further hypotheses related to the collection of value-based medical history."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Older adults aged 65 and above undergoing surgical procedures with oncological diagnosis.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Age ≥ 65 years\n\n * Type of procedure: hemicolectomy, rectal amputation, cystectomy, extensive nephrectomy, malignant brain tumor\n * ASA classification III\n * No sensory impairment (blindness, deafness, deaf-muteness)\n * Patients had access to sensory aids (glasses) during assessment\n * No legal incapacity\n * Consent to participate in the study\n * Signed informed consent\n * Postoperative hospitalization in the ICU (anticipated during pre-anesthetic examination)\n\nExclusion Criteria:\n\n* • Glasgow Coma Scale ≤ 14\n\n * Somnolence, coma\n * Known psychiatric disorder\n * Effect of premedication, psychiatric or analgesic-sedative drugs during cognitive function assessment'}, 'identificationModule': {'nctId': 'NCT07481994', 'acronym': 'Value-Based As', 'briefTitle': 'Changes in Value-Based Assessment in Patients Undergoing Major Oncological Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Tomas Bata Hospital, Czech Republic'}, 'officialTitle': 'Changes in Value-Based Assessment in Patients Undergoing Major Oncological Surgery', 'orgStudyIdInfo': {'id': 'ARIM Tomas Bata Hospital Zlin'}, 'secondaryIdInfos': [{'id': 'Radovan Turek', 'type': 'OTHER', 'domain': 'ARIM Tomas Bata Hospital Zlin'}]}, 'contactsLocationsModule': {'locations': [{'zip': '76001', 'city': 'Zlín', 'country': 'Czechia', 'facility': 'Tomas Bata regional Hospital', 'geoPoint': {'lat': 49.22645, 'lon': 17.67065}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tomas Bata Hospital, Czech Republic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy Head of the Department of Anesthesiology and Intensive Care', 'investigatorFullName': 'Turek Radovan', 'investigatorAffiliation': 'Tomas Bata Hospital, Czech Republic'}}}}