Ignite Creation Date:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2025-12-25 @ 1:50 PM
Study NCT ID:
NCT04463992
Status:
COMPLETED
Last Update Posted:
2025-04-27
First Post:
2020-07-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Lay Health Worker Expanded Intervention in Community Oncology Practices
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003643', 'term': 'Death'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 416}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-10-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-23', 'studyFirstSubmitDate': '2020-07-04', 'studyFirstSubmitQcDate': '2020-07-04', 'lastUpdatePostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '% of patients with Emergency Department Visit within 12-months after patient enrollment (Chart Review)', 'timeFrame': '12 months after patient enrollment', 'description': 'Emergency Department use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment. We will evaluate comparisons of the % of patients with emergency department visits between study arms.'}, {'measure': '% of patients with Hospitalization Visits within 12 months after patient enrollment (Chart Review)', 'timeFrame': '12 months after patient enrollment', 'description': 'Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment. We will evaluate comparisons of hospitalizations between the two study arms.'}], 'secondaryOutcomes': [{'measure': '% of patients with a Hospice Consult within 12-months after patient enrollment (Chart Review)', 'timeFrame': '12 months after patient enrollment', 'description': 'Hospice consult for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment.'}, {'measure': 'Total Health Care Costs (Claims Review)', 'timeFrame': '12 months after patient enrollment', 'description': 'Total Health Care Costs for each patient will be abstracted by medical claims data review for each patient at 12 months after enrollment.'}, {'measure': '% of patients with an Acute Care Facility Death (Chart Review)', 'timeFrame': '30 days prior to death for patients who died at 12-months follow-up', 'description': 'Acute Care Facility Deaths for each patient will be abstracted by electronic medical record chart review and claims review for each patient who has died at 12-months followup. We will evaluate comparisons of Acute Care Facility Deaths between study arms.'}, {'measure': '% of patients with Emergency Department Visit in the last 30 days of life (Chart Review)', 'timeFrame': '30 days prior to death for patients who died at 12-months follow-up', 'description': 'Emergency Department use for each patient will be abstracted by electronic medical record chart review for each patient who has died. We will evaluate comparisons of emergency department visits between study arms.'}, {'measure': '% of patients with Hospitalization Visits in the last 30 days of life (Chart Review)', 'timeFrame': '30 days prior to death for patients who died at 12-months follow-up', 'description': 'Hospital use for each patient will be abstracted by electronic medical record chart review for each patient who has died. We will evaluate comparisons of hospitalization use between study arms.'}, {'measure': '% of patients with a Hospice Consult in the last 30 days of life (Chart Review)', 'timeFrame': '30 days prior to death for patients who died at 12-months follow-up', 'description': 'Hospice use for each patient will be abstracted by electronic medical record chart review for each patient who has died. We will evaluate comparisons of hospice use between study arms.'}, {'measure': 'Total Costs of Care (Claims Review)', 'timeFrame': 'Time of enrollment to 12 months followup or death, whichever is first', 'description': 'Total costs of care for each patient will be obtained through claims data for each patient for each patient who has died. We will evaluate comparisons of Total costs of care between study arms.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cancer end of life patient-centered'], 'conditions': ['End of Life', 'Cancer']}, 'descriptionModule': {'briefSummary': 'Undertreated patient symptoms and resulting acute care use require approaches that improve symptom-burden. Previously a lay health worker (LHW)-led symptom screening intervention was developed for patients with cancer. In pilot work, the intervention was associated with improvements in patient symptom burden and reductions in healthcare use and costs of care at the end of life. This intervention will be expanded across several clinics to evaluate the impact of the LHW intervention on with cancer and the LHW will be trained to refer patients to palliative care. This randomized intervention will evaluate the effect on healthcare use, total costs, palliative care and hospice referral.', 'detailedDescription': 'All patients with newly diagnosed cancer, over the age of 75 will be randomized into the CareMore Pilot 2 Program with 200 randomized to the intervention grou and 200 randomized to the control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '75 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly diagnosed or relapsed cancer diagnosis.\n* 75 years or older\n* Diagnosis of relapse or progressive disease (any cancer diagnosis) as identified by imaging or biopsy and confirmed by physician.\n* Must have capacity to verbally consent\n\nExclusion Criteria:\n\n* Inability to consent to the study due to lack of capacity as documented by the referring physician.'}, 'identificationModule': {'nctId': 'NCT04463992', 'briefTitle': 'Lay Health Worker Expanded Intervention in Community Oncology Practices', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Lay Health Worker Expanded Intervention in Community Oncology Practices', 'orgStudyIdInfo': {'id': '57643'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group Arm', 'description': 'Patients randomized into the intervention will be assigned a lay health worker who will contact the patient to begin the intervention. The intervention includes: proactive symptom assessments for patients for up to 12-months.', 'interventionNames': ['Behavioral: Program participants', 'Other: Usual Care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Behavioral:Program participants', 'description': 'The control group arm will receive usual care as provided by their local oncologists.', 'interventionNames': ['Other: Usual Care']}], 'interventions': [{'name': 'Program participants', 'type': 'BEHAVIORAL', 'description': 'The intervention is a 12-month telephonic program in which a lay health worker (LHW), supervised on-site by a registered nurse practitioner (RNP), assessed patient symptoms after diagnosis using the validated Edmonton Symptom The intervention is a 12-month telephonic program in which a lay health worker (LHW), supervised on-site by a registered nurse practitioner (RNP), assessed patient symptoms after diagnosis using the validated Edmonton Symptom Assessment Scale (ESAS) (cite) with the frequency of symptom assessment varying based on patient risk.', 'armGroupLabels': ['Intervention Group Arm']}, {'name': 'Usual Care', 'type': 'OTHER', 'description': 'Usual care as provided by local oncologists', 'armGroupLabels': ['Behavioral:Program participants', 'Intervention Group Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85710', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'The Oncology Institute of Hope and Innovation', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '89052', 'city': 'Henderson', 'state': 'Nevada', 'country': 'United States', 'facility': 'The Oncology Institute of Hope and Innovation', 'geoPoint': {'lat': 36.0397, 'lon': -114.98194}}], 'overallOfficials': [{'name': 'Manali I Patel, MD MPH MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Manali Indravadan Patel', 'investigatorAffiliation': 'Stanford University'}}}}