Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-25 @ 8:17 PM
Study NCT ID:
NCT03407469
Status:
RECRUITING
Last Update Posted:
2025-11-18
First Post:
2018-01-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Measurement of Adherence and Health-Related Quality of Life, and Health-Care Resource Utilization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 260}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-01-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2018-01-16', 'studyFirstSubmitQcDate': '2018-01-22', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-Reported Adherence to Anticoagulation', 'timeFrame': 'Baseline up to 6 months', 'description': 'Adherence categorized as "adequate" versus "non-adequate" based on the Morisky scale.'}], 'secondaryOutcomes': [{'measure': 'HRQL Variables in Patients for Cancer-Related VTE Treated with Anticoagulation', 'timeFrame': 'Baseline, 3 months, and 6 months', 'description': 'The HRQL variables measured using a deep venous thrombosis quality of life questionnaire: DVTQOL.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Questionnaires', 'Surveys', 'Cancer-related Venous Thromboembolism', 'VTE'], 'conditions': ['Cancer-related Venous Thromboembolism']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'MD Anderson Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'The goal of this research study is to learn about the quality of life, experiences with treatment, and healthcare costs of patients who are receiving long-term treatment for venous thromboembolism (VTE) that is related to cancer.\n\nThis is an investigational study. Up to 260 participants will be enrolled in this multicenter study. Up to 170 will take part in MD Anderson.', 'detailedDescription': 'If you agree to take part in this study, you will complete 2 questionnaires either at an already-scheduled clinic visit or over the phone at the time you join this study and then about 30 days, 3 months, 6 months, and 12 months after that. These questionnaires will be about your quality of life and experiences with treatment for VTE. It should take less than 10 minutes to complete the questionnaires each time.\n\nInformation from your medical record may also be collected at these time points.\n\nYour participation will be over after the last questionnaires are completed at about 12 months after you enroll in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants treated for cancer-related VTE at UT MD Anderson Cancer Center and other institutions.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult (≥ 18 years) female or male subjects.\n2. Confirmed symptomatic proximal or distal lower extremity deep venous thrombosis with or without pulmonary embolism or other venous thromboses. For a symptomatic lower extremity deep venous thrombosis confirmed by compression ultrasonography, venography, or specific computerized tomography (CT) venography, or a thrombus detected in the iliac veins on an abdominal or pelvic CT. For symptomatic pulmonary embolism confirmed by computerized tomographic pulmonary angiography, ventilation perfusion scan, or catheter pulmonary angiography.\n3. Cancer (other than basal-cell or squamous-cell carcinoma of the skin), either active or diagnosed within 2 years prior to VTE. The diagnosis of cancer must be objectively documented by histopathologic diagnosis.\n4. Intention for long-term treatment (at least 3 months) with anticoagulation.\n5. Participants will be enrolled in the study within the first 5 days from initiation of anticoagulation.\n6. Able to provide informed consent and complete study survey tools\n7. Able to read and speak English.\n\nExclusion Criteria:\n\n1. Indication for anticoagulation other than cancer-related VTE.\n2. An Eastern Cooperative Oncology Group (ECOG) Performance Status of 4 at the time of study enrollment.\n3. Life expectancy \\< 3 months.\n4. Isolated pulmonary embolism, or isolated upper extremity deep venous thrombosis, or isolated splanchnic venous thrombosis, or isolated cerebral venous thrombosis confirmed by compression ultrasonography, venography, or CT.'}, 'identificationModule': {'nctId': 'NCT03407469', 'briefTitle': 'Measurement of Adherence and Health-Related Quality of Life, and Health-Care Resource Utilization', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Measurement of Adherence and Health-related Quality of Life, and Health-Care Resource Utilization During Anticoagulation Therapy in Cancer-Related Venous Thromboembolism (VTE)', 'orgStudyIdInfo': {'id': '2017-0303'}, 'secondaryIdInfos': [{'id': 'NCI-2018-00900', 'type': 'REGISTRY', 'domain': 'NCI CTRP'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Questionnaires', 'description': 'Questionnaires completed at the time participant joins this study and then about 30 days, 3 months, 6 months, and 12 months after that. Questionnaires will be about quality of life and experiences with treatment for venous thromboembolism (VTE).', 'interventionNames': ['Behavioral: Questionnaires']}], 'interventions': [{'name': 'Questionnaires', 'type': 'BEHAVIORAL', 'otherNames': ['Surveys'], 'description': 'Questionnaires completed at the time participant joins this study and then about 30 days, 3 months, 6 months, and 12 months after that. Questionnaires will be about quality of life and experiences with treatment for venous thromboembolism (VTE). It should take less than 10 minutes to complete the questionnaires each time.', 'armGroupLabels': ['Questionnaires']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Cristhiam M Rojas Hernandez, MD', 'role': 'CONTACT', 'email': 'cmrojas@mdanderson.org'}], 'facility': 'University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'Cali', 'status': 'RECRUITING', 'country': 'Colombia', 'contacts': [{'name': 'Juan E Gomez-Mesa, MD', 'role': 'CONTACT'}, {'role': 'CONTACT', 'email': 'juanestebang@yahoo.com'}], 'facility': 'Fundacion Valle del Lili', 'geoPoint': {'lat': 3.43054, 'lon': -76.5199}}, {'zip': '08036', 'city': 'Barcelona', 'state': 'Carrer de Villarroel, 170', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Carme Font, MD', 'role': 'CONTACT'}], 'facility': 'Hospital Clinic', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08916', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': ': Juan J Lopez Nuñez, MD', 'role': 'CONTACT'}, {'role': 'CONTACT', 'email': 'jjlopez.germanstrias@gencat.cat'}], 'facility': 'Hospital German Trias i Pujol', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'centralContacts': [{'name': 'Cristhiam M. Rojas Hernandez, MD', 'role': 'CONTACT', 'email': 'cmrojas@mdanderson.org', 'phone': '713-563-3070'}], 'overallOfficials': [{'name': 'Cristhiam M. Rojas Hernandez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}