Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-31 @ 3:34 PM
Study NCT ID:
NCT04727294
Status:
UNKNOWN
Last Update Posted:
2021-08-04
First Post:
2021-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MGUS, SMM, and MM Patient Experience With Coronavirus 19 (COVID-19) Survey
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2022-03-24', 'releaseDate': '2022-03-23'}, {'resetDate': '2022-04-05', 'releaseDate': '2022-03-25'}, {'resetDate': '2023-07-03', 'releaseDate': '2022-08-04'}], 'estimatedResultsFirstSubmitDate': '2022-03-23'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D000075122', 'term': 'Smoldering Multiple Myeloma'}, {'id': 'D008998', 'term': 'Monoclonal Gammopathy of Undetermined Significance'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D006942', 'term': 'Hypergammaglobulinemia'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, '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': 1500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-02', 'studyFirstSubmitDate': '2021-01-26', 'studyFirstSubmitQcDate': '2021-01-26', 'lastUpdatePostDateStruct': {'date': '2021-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'COVID-19 Diagnosis and Treatment', 'timeFrame': 'Up to one year', 'description': 'Describe how patients diagnosed with COVID-19 were treated for the virus.'}, {'measure': 'Changes to Myeloma Treatment and Care', 'timeFrame': 'Up to one year', 'description': 'Describe which treatments were changed and how care was affected as a result of COVID-19'}, {'measure': 'Health and Fitness', 'timeFrame': 'Up to one year', 'description': "Describe how COVID-19 impacted patient's health and fitness"}, {'measure': 'Quality of Life (QOL) Distress Screening tool', 'timeFrame': 'Up to one year', 'description': "Describe how patients rate their level of concern on psychosocial, practical, and physical needs during the COVID-19 pandemic using the Cancer Support Community's CancerSupportSource distress screening tool."}], 'secondaryOutcomes': [{'measure': 'Clinical Trial Familiarity', 'timeFrame': 'Upon enrollment', 'description': 'Describe how familiar patients are with multiple myeloma clinical trials.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Questionnaire'], 'conditions': ['Multiple Myeloma', 'Smoldering Multiple Myeloma', 'Monoclonal Gammopathy of Undetermined Significance', 'Coronavirus']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine how patients with multiple myeloma (MM) have been impacted by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic.\n\nThe study will use a questionnaire to further understand how patients are being affected and gather information in order to track the long-term effects of the coronavirus.\n\nThe scope of the questionnaire will include, COVID-19 diagnosis and treatment, changes in myeloma treatment and care, clinical trial familiarity, health and fitness, and quality of life.\n\nThis questionnaire is a follow-on to the "MM and COVID-19" questionnaire.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with MGUS, smoldering myeloma, or multiple myeloma.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (greater than 18 years) diagnosed with MGUS, smoldering myeloma, and multiple myeloma.\n* Access to a computer or electronic device with internet access, or phone\n* Willing to create a patient profile on the HealthTree Cure Hub For Multiple Myeloma\n* Willing to give electronically-signed consent\n* Ability to read questions in English'}, 'identificationModule': {'nctId': 'NCT04727294', 'briefTitle': 'MGUS, SMM, and MM Patient Experience With Coronavirus 19 (COVID-19) Survey', 'organization': {'class': 'OTHER', 'fullName': 'HealthTree Foundation'}, 'officialTitle': 'Monoclonal Gammopathy of Undetermined Significance (MGUS), Smoldering Myeloma (SMM), and Multiple Myeloma Patient Experience With COVID-19 Survey', 'orgStudyIdInfo': {'id': 'MM/COVID-19 part II'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MGUS, SMM, MM Patients or their Caregivers', 'description': 'Eligible participants will be asked to create a free patient profile on the HealthTree Cure Hub (www.healthtree.org) or use their existing patient profile.\n\nThe creation of a HealthTree Cure Hub patient profile will serve as a screen for eligibility.\n\nPatients will complete a one-time questionnaire found on the HealthTree Cure Hub. Telephone assistance can be provided as needed. The questionnaire will take 20-30 minutes to complete.', 'interventionNames': ['Behavioral: Questionnaire']}], 'interventions': [{'name': 'Questionnaire', 'type': 'BEHAVIORAL', 'description': 'Series of questions covering COVID-19 diagnosis and treatment, changes in myeloma treatment and care, clinical trial familiarity, health and fitness, and quality of life.', 'armGroupLabels': ['MGUS, SMM, MM Patients or their Caregivers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84043', 'city': 'Lehi', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nathan Sweeney, PhD', 'role': 'CONTACT', 'email': 'nathan@healthtree.org', 'phone': '800-709-1113'}, {'name': 'Ana Sahagun, MS', 'role': 'CONTACT', 'phone': '1-800-709-1113'}], 'facility': 'HealthTree.org (Online)', 'geoPoint': {'lat': 40.39162, 'lon': -111.85077}}], 'centralContacts': [{'name': 'Nathan Sweeney, PhD', 'role': 'CONTACT', 'email': 'nathan@healthtree.org', 'phone': '18007091113'}], 'overallOfficials': [{'name': 'Nathan Sweeney, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'HealthTree Foundation'}]}, 'ipdSharingStatementModule': {'url': 'http://healthtree.org', 'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'CSR'], 'ipdSharing': 'YES', 'description': 'The HealthTree foundation values responsible and ethical sharing of data from clinical trials. De-identified patient responses to the questionnaire will be aggregated and shared back with the patient. Additionally, portions of the de-identified results will be shared with the research community through publications (abstracts, reports, manuscripts).', 'accessCriteria': "Visit the HealthTree Foundation's online patient portal: HealthTree Cure Hub For Multiple Myeloma"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HealthTree Foundation', 'class': 'OTHER'}, 'collaborators': [{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-03-23', 'type': 'RELEASE'}, {'date': '2022-03-24', 'type': 'RESET'}, {'date': '2022-03-25', 'type': 'RELEASE'}, {'date': '2022-04-05', 'type': 'RESET'}, {'date': '2022-08-04', 'type': 'RELEASE'}, {'date': '2023-07-03', 'type': 'RESET'}], 'unpostedResponsibleParty': 'HealthTree Foundation'}}}}