Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2026-02-21 @ 9:25 PM
Study NCT ID:
NCT01795157
Status:
COMPLETED
Last Update Posted:
2017-09-25
First Post:
2013-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Computer Based Assessment and Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 255}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-20', 'studyFirstSubmitDate': '2013-02-18', 'studyFirstSubmitQcDate': '2013-02-18', 'lastUpdatePostDateStruct': {'date': '2017-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-02-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'average and worst pain during the last 24 hours', 'timeFrame': '1 week', 'description': '\\- The Brief Pain Inventory (BPI, a self-reported pain assessment tool aiming to quantify two aspects of cancer pain: Pain intensity and the functional disability as a result of cancer pain.'}, {'measure': 'average and worst pain during the last 24 hours', 'timeFrame': '3 weeks', 'description': '\\- The Brief Pain Inventory (BPI, a self-reported pain assessment tool aiming to quantify two aspects of cancer pain: Pain intensity and the functional disability as a result of cancer pain.'}, {'measure': 'average and worst pain during the last 24 hours', 'timeFrame': '1 week', 'description': "\\- The Alberta Breakthrough Pain Assessment Tool for cancer patients (ABPAT), a questionnaire developed in order to measure several dimensions of cancer-related breakthrough pain. It contains 15 questions, and was translated into Norwegian by our research group according to EORTC's rules for translation."}, {'measure': 'average and worst pain during the last 24 hours', 'timeFrame': '3 weeks', 'description': "\\- The Alberta Breakthrough Pain Assessment Tool for cancer patients (ABPAT), a questionnaire developed in order to measure several dimensions of cancer-related breakthrough pain. It contains 15 questions, and was translated into Norwegian by our research group according to EORTC's rules for translation."}], 'secondaryOutcomes': [{'measure': 'symptoms', 'timeFrame': '1 week', 'description': '\\- The Edmonton Symptom Assessment System (ESAS), a validated standardized questionnaire consisting of 10 items, which evaluate physical and psychological symptoms as well as general wellbeing.'}, {'measure': 'symptoms', 'timeFrame': '3 weeks', 'description': '\\- The Edmonton Symptom Assessment System (ESAS), a validated standardized questionnaire consisting of 10 items, which evaluate physical and psychological symptoms as well as general wellbeing.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['decision support systems, clinical', 'decision making, computer assisted', 'evidence based practice', 'practice guidelines as topic'], 'conditions': ['Neoplasms', 'Pain']}, 'referencesModule': {'references': [{'pmid': '28850380', 'type': 'RESULT', 'citation': 'Raj SX, Brunelli C, Klepstad P, Kaasa S. COMBAT study - Computer based assessment and treatment - A clinical trial evaluating impact of a computerized clinical decision support tool on pain in cancer patients. Scand J Pain. 2017 Oct;17:99-106. doi: 10.1016/j.sjpain.2017.07.016. Epub 2017 Aug 8.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to investigate computer based symptom assessment in an outpatient cancer population, and the use of a computer based decision support system to facilitate the diagnosis and treatment of cancer related pain.\n\nPrimary hypothesis is, that this approach improves pain control and pain management in an unselected group of cancer patients in an outpatient setting.\n\n* Improvement of average pain last 24 hours by at least 1.5 points on a 0-11 scale\n* Improvement of worst pain last 24 hours by at least 1.5 points on a 0-11 scale\n* An alteration in the prescribing dose of opioids in equipotent opioid dosage\n\nSecondary hypothesis is, that this system improves overall symptom control and symptom management in an unselected group of cancer patients in an outpatient setting.', 'detailedDescription': 'The traditional way of symptom assessment is by the paper-and-pen method, which suffers from several limitations. The assessment items are not individually adjusted to each patient and his/her subjective symptoms, the collected data is rarely used in clinical practice, and decision-support for the physician is not possible.\n\nAlthough the body of evidence is accumulating regarding the benefits of computerised symptom assessment in cancer patients, there is still insufficient knowledge of the impact of computerised assessment tools on the management of cancer pain and other cancer related symptoms.\n\nThe COMBAT study aims to investigate if a computer based assessment of cancer related symptoms, and a computerized decision support can improve treatment of pain and other symptoms in cancer patients.\n\nThis is an open, comparative study with a sequential design with two consecutive study periods, the non-intervention period and the intervention period.\n\nThe computer-based clinical decision support system will utilize the following data to generate one or several treatment options:\n\n1. Data from self assessment of cancer related symptoms\n2. Data from relevant variables reported by the physician\n3. Revisited guidelines on treatment of cancer pain'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* attending the outpatient clinic at the Cancer Clinic, St. Olavs Hospital Trondheim\n* histologically verified malignancy\n* able to follow study instructions\n* able to read the information on the computer screen in the intervention period of the study\n* able to use a touch screen in the intervention period of the study\n* cancer related pain measured as average pain in last 24 hours of 4 or above on a numeric rating scale\n* elective or emergency consultation with a physician'}, 'identificationModule': {'nctId': 'NCT01795157', 'acronym': 'COMBAT', 'briefTitle': 'Computer Based Assessment and Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian University of Science and Technology'}, 'officialTitle': 'Computer Based Assessment and Treatment', 'orgStudyIdInfo': {'id': '2009/859'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CCADSS', 'description': 'questionnaire completed using i-Pad', 'interventionNames': ['Device: CCADSS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'pen-paper', 'description': 'Questionnaire completed using pen and paper', 'interventionNames': ['Device: pen-paper']}], 'interventions': [{'name': 'CCADSS', 'type': 'DEVICE', 'description': "Questionnaire is transferred wireless to the physician's PC", 'armGroupLabels': ['CCADSS']}, {'name': 'pen-paper', 'type': 'DEVICE', 'description': 'Questionnaire completed and transferred to the physician using standard methods', 'armGroupLabels': ['pen-paper']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Trondheim', 'country': 'Norway', 'facility': 'Department of Oncology outpatient clinic, St Olavs Hospital', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Stein Kaasa, MD prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Norwegian University of Science and Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'St. Olavs Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}