Ignite Creation Date:
2025-12-24 @ 5:21 PM
Ignite Modification Date:
2025-12-27 @ 6:57 PM
Study NCT ID:
NCT05974150
Status:
RECRUITING
Last Update Posted:
2025-02-12
First Post:
2023-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real World Treatment Experience of Patients With Breast, Lung, Ovarian, Multiple Myeloma, or Acute Myelogenous Leukemia Using Remote Symptom Monitoring
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'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': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-11', 'studyFirstSubmitDate': '2023-07-26', 'studyFirstSubmitQcDate': '2023-08-02', 'lastUpdatePostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Create Data Set', 'timeFrame': '1 year', 'description': 'The goal of this registry is to create a data set from real world clinical and patient reported data collected using an electronic care planning system (CPS) that is used in routine care for cancer patients on active treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer', 'Lung Cancer', 'Multiple Myeloma', 'Ovarian Cancer', 'Acute Myelogenous Leukemia']}, 'descriptionModule': {'briefSummary': "The goal of this study is to create a data set to add to Carevive's registry from real world clinical and patient reported data collected using an electronic care planning system (CPS) with remote symptom monitoring that is used in routine care for cancer patients on active treatment.\n\nPatients will complete a baseline survey in person using a secured device or remotely using their own electronic device in a location of their choice. Weekly electronic patient reported outcome (PRO) surveys are collected from the patients using the Carevive platform for a minimum of 12 weeks. Patients may continue weekly surveys as long as they are receiving treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients receiving cancer treatment for breast, lung, GI or multiple myeloma', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All participants must be 18 years of age or older.\n* Subjects may be any stage and anywhere in the treatment continuum.\n* Subject participants must have a diagnosis of a breast, lung, AML, ovarian cancer or multiple myeloma.\n* Subjects must be able to complete on-line surveys using a cell phone, tablet, or computer.\n* All participants must be able to understand English.\n\nExclusion Criteria:\n\n* Any patient who cannot understand written or spoken English.\n* Any patient without the ability to complete on-line surveys using a cell phone, tablet, or computer.\n* Any patient on a treatment clinical trial.\n* Any prisoner and/or other vulnerable persons as defined by NIH (45 CFR 46, Subpart B, C and D).'}, 'identificationModule': {'nctId': 'NCT05974150', 'briefTitle': 'Real World Treatment Experience of Patients With Breast, Lung, Ovarian, Multiple Myeloma, or Acute Myelogenous Leukemia Using Remote Symptom Monitoring', 'nctIdAliases': ['NCT05974137'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Carevive Systems, Inc.'}, 'officialTitle': 'Real World Treatment Experience of Patients With Breast, Lung, Ovarian, Multiple Myeloma, or Acute Myelogenous Leukemia (AML) Using Remote Symptom Monitoring', 'orgStudyIdInfo': {'id': 'OPT-IN Carevive Registry'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Web based survey', 'type': 'OTHER', 'description': 'online weekly survey'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kim Blenman', 'role': 'CONTACT', 'email': 'kim.blenman@yale.edu'}, {'name': 'Kim Blenman', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Yale Cancer Center', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '31024', 'city': 'Evanston', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michele Britto', 'role': 'CONTACT', 'email': 'MBritto@northshore.org'}, {'name': 'Nicklas Pfanzelter', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Northshore University Health System', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Univeristy of North Carolina at Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27707', 'city': 'Durham', 'state': 'North Carolina', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Duke', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44708', 'city': 'Canton', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Janet Muckley', 'role': 'CONTACT', 'email': 'MUCKLEJ@ccf.org'}, {'name': 'Mitchell Haut, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cleveland Clinic Mercy Hospital', 'geoPoint': {'lat': 40.79895, 'lon': -81.37845}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jill Severino-Powell, MSN', 'role': 'CONTACT', 'email': 'Jill.Severino-Powell@UHhospitals.org'}, {'name': 'Alberto Montero, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospitals Seidman Cancer Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44646', 'city': 'Massillon', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Janet Muckley', 'role': 'CONTACT', 'email': 'MUCKLEJ@ccf.org'}, {'name': 'Nagaprasad Nagajothi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tri-County Hematology & Oncology Associates, Inc.', 'geoPoint': {'lat': 40.79672, 'lon': -81.52151}}], 'centralContacts': [{'name': 'JULIE SCOTT, MSN', 'role': 'CONTACT', 'email': 'Julie.Scott@Carevive.com', 'phone': '8778423210'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carevive Systems, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}