Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2026-01-16 @ 9:02 PM
Study NCT ID:
NCT05809557
Status:
COMPLETED
Last Update Posted:
2024-02-28
First Post:
2023-03-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EMR Chemotoxicity Risk Calculator To Decrease Chemotherapy Toxicity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Providers, who were selected based on having at least 20 new patients with metastatic solid tumors in a 6-month period in 2021, will be randomized in a 1:1 ratio, stratified by quartiles of patient volume.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-01-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-27', 'studyFirstSubmitDate': '2023-03-30', 'studyFirstSubmitQcDate': '2023-03-30', 'lastUpdatePostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Unplanned hospitalization rate', 'timeFrame': 'Within 3 months of the Index Visit with the oncologist', 'description': 'Measured at the patient level as a binary outcome (yes/no) based on date of initial visit with the oncologist.'}], 'secondaryOutcomes': [{'measure': 'Healthcare contact days', 'timeFrame': 'Within 3 and 6 months of the Index Visit with the oncologist', 'description': 'Measured at the patient level as a continuous outcome (number of days).'}, {'measure': 'Chemotherapy use rate', 'timeFrame': 'Within 3 months of the Index Visit with the oncologist', 'description': 'Measured at the patient level as a binary outcome (yes/no) if patient ever received systemic cancer-directed treatment.'}, {'measure': 'Chemotherapy modification rate', 'timeFrame': 'Within 3 months of the Index Visit with the oncologist', 'description': 'Measured at the patient level as a binary outcome (yes/no) if patient had dose, schedule, or number of chemotherapy changed.'}, {'measure': 'Palliative Care Referral', 'timeFrame': 'Within 6 months of the Index Visit with the oncologist', 'description': 'Measured at the patient level as a binary outcome (yes/no) based on presence of a scheduled palliative care appointment'}, {'measure': 'Chemotherapy toxicity tool use rate', 'timeFrame': 'Within 3 months of the Index Visit with the oncologist', 'description': 'Measured at the patient level as a binary outcome (yes/no) based on whether the oncologist used the tool for that patient.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Oncology', 'Chemotherapeutic Toxicity', 'Metastatic Solid Tumor']}, 'descriptionModule': {'briefSummary': 'This study will formally test the quality improvement intervention of an EMR based tool that informs medical oncologists visiting a patient for the first time of potential risk of chemotherapy toxicity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* New outpatient visits with a medical oncologist following a new diagnosis of cancer and no prior history of chemotherapy treatment.\n* aged \\> 65 will be included.\n\nExclusion Criteria:\n\n* Patients who opt out of clinical research will be excluded from analysis, but not the intervention (which will be applied to all patients). Specifically, as sometimes opt-in/opt out status is coded ambiguously in the data we will only analyze results of patients with clear opt in and no history of opt out.\n* Patients with no EHR data after initial oncologist appointment.'}, 'identificationModule': {'nctId': 'NCT05809557', 'briefTitle': 'EMR Chemotoxicity Risk Calculator To Decrease Chemotherapy Toxicity', 'organization': {'class': 'OTHER', 'fullName': 'Masonic Cancer Center, University of Minnesota'}, 'officialTitle': 'Effect of an EMR Chemotoxicity Risk Calculator Availability To Decrease Chemotherapy Toxicity in Adults With Cancer', 'orgStudyIdInfo': {'id': '2022LS125'}, 'secondaryIdInfos': [{'id': 'STUDY00015357', 'type': 'OTHER', 'domain': 'IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Usual Care', 'interventionNames': ['Other: Oncology Consultation']}, {'type': 'EXPERIMENTAL', 'label': 'Chemotherapy Toxicity Tool', 'interventionNames': ['Other: Chemotherapy toxicity tool', 'Other: Oncology Consultation']}], 'interventions': [{'name': 'Chemotherapy toxicity tool', 'type': 'OTHER', 'otherNames': ['CARG'], 'description': 'CARG is an EMR based tool that informs medical oncologists visiting a patient for the first time of potential risk of chemotherapy toxicity. This intervention will make available a simple calculator which includes: Gender, Height and weight, Cancer Subtype, Hemoglobin, How is your hearing (with hearing aid, if needed)?, Number of falls in the past 6 months, Can you take your own medicines, Does your health limit you in walking one block., During the past 4 weeks, how much of the time has your physical health or emotional problems interfered with your social activities (like visiting with friends, relatives, etc.)? and Glomerular filtration rate.\n\nThe CARG chemotoxicity calculator will be built into the patient navigator and its use will be assessed on a monthly basis and used to inform iteration.', 'armGroupLabels': ['Chemotherapy Toxicity Tool']}, {'name': 'Oncology Consultation', 'type': 'OTHER', 'description': 'Oncologists will consult new patient with a new diagnosis of cancer.', 'armGroupLabels': ['Chemotherapy Toxicity Tool', 'Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Masonic Cancer Center, University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'All data will be housed as subset within the existing Center for Learning Health System Science/Center for Quality Outcomes, Discovery and Evaluation database covered by IRB 597 Protocol: STUDY00014481. Patient level data will not be shared with anyone outside the study team. Aggregated data will be shared with quality officials, hospital administrators, and more broadly disseminated in academic meetings and for publication.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Masonic Cancer Center, University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}