Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-26 @ 12:48 AM
Study NCT ID:
NCT00972634
Status:
COMPLETED
Last Update Posted:
2017-01-18
First Post:
2009-09-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Computerized Questionnaires in Assessing Symptoms, Pain, Depression, and Physical Function in Patients With Metastatic and/or Advanced Locoregional Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002100', 'term': 'Cachexia'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013851', 'term': 'Thinness'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1051}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-16', 'studyFirstSubmitDate': '2009-09-04', 'studyFirstSubmitQcDate': '2009-09-04', 'lastUpdatePostDateStruct': {'date': '2017-01-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of applying a computer based system for symptom assessment and classification in palliative cancer care', 'timeFrame': 'Sept 2008-December 2009'}, {'measure': 'Differences across groups related to acceptance of computers (i.e., age, culture, stage of disease, cognitive and physical function, etc.)', 'timeFrame': 'Sept 2008-December 2009'}, {'measure': 'General user-friendliness of the tool', 'timeFrame': 'Sept 2008-December 2009'}, {'measure': 'Performance of selected domains and items for classification and assessment of pain and cachexia', 'timeFrame': 'Sept 2008-December 2009'}, {'measure': 'Validity of domains and items for depression', 'timeFrame': 'Sept 2008-December 2009'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['depression', 'cachexia', 'pain', 'unspecified adult solid tumor, protocol specific'], 'conditions': ['Cachexia', 'Depression', 'Pain', 'Unspecified Adult Solid Tumor, Protocol Specific']}, 'referencesModule': {'references': [{'pmid': '22795905', 'type': 'RESULT', 'citation': 'Hjermstad MJ, Lie HC, Caraceni A, Currow DC, Fainsinger RL, Gundersen OE, Haugen DF, Heitzer E, Radbruch L, Stone PC, Strasser F, Kaasa S, Loge JH; European Palliative Care Research Collaborative (EPCRC). Computer-based symptom assessment is feasible in patients with advanced cancer: results from an international multicenter study, the EPCRC-CSA. J Pain Symptom Manage. 2012 Nov;44(5):639-54. doi: 10.1016/j.jpainsymman.2011.10.025. Epub 2012 Jul 13.'}, {'pmid': '27342412', 'type': 'DERIVED', 'citation': 'Hjermstad MJ, Kaasa S, Caraceni A, Loge JH, Pedersen T, Haugen DF, Aass N; European Palliative Care Research Collaborative (EPCRC). Characteristics of breakthrough cancer pain and its influence on quality of life in an international cohort of patients with cancer. BMJ Support Palliat Care. 2016 Sep;6(3):344-52. doi: 10.1136/bmjspcare-2015-000887. Epub 2016 Jun 24.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: A computer-based system for assessing symptoms may be effective for patients with metastatic or advanced cancer.\n\nPURPOSE: This clinical trial is studying how well computerized questionnaires work in assessing symptoms, pain, depression, and physical function in patients with metastatic and/or advanced local/regional cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the feasibility of applying a computer-based system for symptom assessment and classification in palliative cancer care in patients with metastatic and/or advanced cancer.\n* Examine hypothesized differences across groups related to acceptance of computers (i.e., age, culture, stage of disease, cognitive and physical function, etc.).\n* Examine the general user-friendliness of the tool.\n* Test and validate the performance of selected domains and items for classification and assessment of pain and cachexia.\n* Explore the validity of domains and items for depression.\n\nOUTLINE: This is a multicenter study.\n\nAll patients undergo computer-based assessments of general symptoms by the Edmonton Symptom Assessment System (ESAS) and the European Organization for Research and Treatment of Cancer Core Quality of Life (EORTC QLQ C30) questionnaires and assessment of physical function, appetite/weight loss, and depression by the Brief Patient Health Questionnaire 9 (PRIME-MD PHQ9). Patients who score ≥ 1 (on a 0-10 numerical rating score) on the pain screening question with or without occurrence of breakthrough pain (BTP), undergo the Alberta BTP Assessment tool assessing precipitating factors for pain, time to pain relief after intake of medication, and satisfaction with medication. Patients complete questions regarding user-friendliness and feasibility of using the computer at the end of their session.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of incurable cancer, including patients receiving life-prolonging treatment\n* Metastatic and/or advanced locoregional disease\n\nPATIENT CHARACTERISTICS:\n\n* Able to provide written informed consent\n* Fluent in the language used at the study site\n\nPRIOR CONCURRENT THERAPY:\n\n* No prior inclusion in this study'}, 'identificationModule': {'nctId': 'NCT00972634', 'briefTitle': 'Computerized Questionnaires in Assessing Symptoms, Pain, Depression, and Physical Function in Patients With Metastatic and/or Advanced Locoregional Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian University of Science and Technology'}, 'officialTitle': 'The European Palliative Care Research Collaborative - Computerised Symptom Assessment and Classification of Pain, Depression and Physical Function (Cachexia) (EPCRC - CSA)', 'orgStudyIdInfo': {'id': 'CDR0000648077'}, 'secondaryIdInfos': [{'id': 'NUST-EPCRC-CSA'}, {'id': 'EU-20962'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'computer-assisted intervention', 'type': 'OTHER', 'description': 'symptom assessment'}, {'name': 'questionnaire administration', 'type': 'OTHER', 'description': 'Symptom assessment'}, {'name': 'assessment of therapy complications', 'type': 'PROCEDURE', 'description': 'Symptom assessment'}, {'name': 'quality-of-life assessment', 'type': 'PROCEDURE', 'description': 'Symptom assessment'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N-7006', 'city': 'Trondheim', 'country': 'Norway', 'facility': 'Norwegian University of Science and Technology', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Stein Kaasa, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Norwegian University of Science and Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}