Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-02-20 @ 1:44 PM
Study NCT ID:
NCT03737058
Status:
COMPLETED
Last Update Posted:
2025-02-27
First Post:
2018-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Lay Health Worker Led Symptom Assessment Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'manalip@stanford.edu', 'phone': '650-723-4000', 'title': 'Manali I Patel, MD MPH MS', 'organization': 'Stanford University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The study was limited to one community oncology practice and to a Medicare Advantage population.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected between time of enrollment and 1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Control Group', 'description': 'All participants in the control group received usual cancer care provided by Oncology Institute for Hope and Innovation clinics.', 'otherNumAtRisk': 102, 'deathsNumAtRisk': 102, 'otherNumAffected': 0, 'seriousNumAtRisk': 102, 'deathsNumAffected': 29, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Intervention Group', 'description': "The intervention consisted of a 12-month telephonic program in which a lay health-worker (LHW), supervised by a physician assistant, assessed patient symptoms after diagnosis using the Edmonton Symptom Assessment Scale (ESAS) Participants were then sorted into two categories: High-risk or low-risk. For high-risk patients, the LHW conducted weekly telephone screenings until the patient's risk changed or death. For low-risk patients, the intervention was conducted by the LHW on a monthly basis.", 'otherNumAtRisk': 186, 'deathsNumAtRisk': 186, 'otherNumAffected': 0, 'seriousNumAtRisk': 186, 'deathsNumAffected': 73, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Edmonton Symptom Assessment Scale Score (ESAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'All participants in the control group received usual cancer care provided by Oncology Institute for Hope and Innovation clinics.'}, {'id': 'OG001', 'title': 'Intervention Group', 'description': "The intervention consisted of a 12-month telephonic program in which a lay health-worker (LHW), supervised by a physician assistant, assessed patient symptoms after diagnosis using the Edmonton Symptom Assessment Scale (ESAS) Participants were then sorted into two categories: High-risk or low-risk. For high-risk patients, the LHW conducted weekly telephone screenings until the patient's risk changed or death. For low-risk patients, the intervention was conducted by the LHW on a monthly basis."}], 'classes': [{'title': 'Symptom score at enrollment', 'categories': [{'measurements': [{'value': '9.6', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '10'}]}]}, {'title': 'Symptom score after 12 months', 'categories': [{'measurements': [{'value': '7.2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '8'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months after patient enrollment', 'description': 'ESAS measures participant responses to 10 common symptoms (pain, fatigue, nausea, depression, anxiety, drowsiness, shortness of breath, appetite, sleep problems, and feeling of well-being). Participants rate the intensity of 10 symptoms, each on a 11-point scale (0 to 10); sub-scores are then summed and averaged to create a total symptom score (range: 0 to 10, with 10 corresponding to worst symptom severity).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants in the intervention group were invited to complete the ESAS.'}, {'type': 'SECONDARY', 'title': 'Incidence of Emergency Department Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'All participants in the control group received usual cancer care provided by Oncology Institute for Hope and Innovation clinics.'}, {'id': 'OG001', 'title': 'Intervention Group', 'description': "The intervention consisted of a 12-month telephonic program in which a lay health-worker (LHW), supervised by a physician assistant, assessed patient symptoms after diagnosis using the Edmonton Symptom Assessment Scale (ESAS) Participants were then sorted into two categories: High-risk or low-risk. For high-risk patients, the LHW conducted weekly telephone screenings until the patient's risk changed or death. For low-risk patients, the intervention was conducted by the LHW on a monthly basis."}], 'classes': [{'categories': [{'measurements': [{'value': '0.92', 'groupId': 'OG000'}, {'value': '0.61', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months after patient enrollment', 'description': 'Emergency Department use for each patient abstracted from medical claims data review for each patient at 12 months after enrollment.', 'unitOfMeasure': 'visits per 1000 members/yr.', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hospitalization Visits (Claims Review)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'All participants in the control group received usual cancer care provided by Oncology Institute for Hope and Innovation clinics.'}, {'id': 'OG001', 'title': 'Intervention Group', 'description': "The intervention consisted of a 12-month telephonic program in which a lay health-worker (LHW), supervised by a physician assistant, assessed patient symptoms after diagnosis using the Edmonton Symptom Assessment Scale (ESAS) Participants were then sorted into two categories: High-risk or low-risk. For high-risk patients, the LHW conducted weekly telephone screenings until the patient's risk changed or death. For low-risk patients, the intervention was conducted by the LHW on a monthly basis."}], 'classes': [{'title': 'No. of Admissions', 'categories': [{'measurements': [{'value': '1.02', 'spread': '1.44', 'groupId': 'OG000'}, {'value': '0.72', 'spread': '0.96', 'groupId': 'OG001'}]}]}, {'title': 'No. of readmissions', 'categories': [{'measurements': [{'value': '0.10', 'spread': '0.41', 'groupId': 'OG000'}, {'value': '0.18', 'spread': '0.47', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months after patient enrollment', 'description': 'Hospitalization Use for each patient will be abstracted by medical claims data review for each patient at 12 months after enrollment.', 'unitOfMeasure': 'number of visits', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Intensive Care Unit Visits (Claims Review)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'All participants in the control group received usual cancer care provided by Oncology Institute for Hope and Innovation clinics.'}, {'id': 'OG001', 'title': 'Intervention Group', 'description': "The intervention consisted of a 12-month telephonic program in which a lay health-worker (LHW), supervised by a physician assistant, assessed patient symptoms after diagnosis using the Edmonton Symptom Assessment Scale (ESAS) Participants were then sorted into two categories: High-risk or low-risk. For high-risk patients, the LHW conducted weekly telephone screenings until the patient's risk changed or death. For low-risk patients, the intervention was conducted by the LHW on a monthly basis."}], 'classes': [{'categories': [{'measurements': [{'value': '0.66', 'spread': '1.23', 'groupId': 'OG000'}, {'value': '0.60', 'spread': '1.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months after patient enrollment', 'description': 'Intensive Care Unit Visits for each patient will be abstracted by medical claims data review for each patient at 12 months after enrollment.', 'unitOfMeasure': 'number of visits', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Health Care Costs (Claims Review)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'All participants in the control group received usual cancer care provided by Oncology Institute for Hope and Innovation clinics.'}, {'id': 'OG001', 'title': 'Intervention Group', 'description': "The intervention consisted of a 12-month telephonic program in which a lay health-worker (LHW), supervised by a physician assistant, assessed patient symptoms after diagnosis using the Edmonton Symptom Assessment Scale (ESAS) Participants were then sorted into two categories: High-risk or low-risk. For high-risk patients, the LHW conducted weekly telephone screenings until the patient's risk changed or death. For low-risk patients, the intervention was conducted by the LHW on a monthly basis."}], 'classes': [{'categories': [{'measurements': [{'value': '31,946', 'groupId': 'OG000', 'lowerLimit': '15,754', 'upperLimit': '57,369'}, {'value': '21,266', 'groupId': 'OG001', 'lowerLimit': '8,102', 'upperLimit': '47,900'}]}]}], 'paramType': 'MEDIAN', '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.', 'unitOfMeasure': '$USD', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Patient Satisfaction With Care Using the Consumer Assessment of Health Care Providers and Systems -General Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'All participants in the control group received usual cancer care provided by Oncology Institute for Hope and Innovation clinics.'}, {'id': 'OG001', 'title': 'Intervention Group', 'description': "The intervention consisted of a 12-month telephonic program in which a lay health-worker (LHW), supervised by a physician assistant, assessed patient symptoms after diagnosis using the Edmonton Symptom Assessment Scale (ESAS) Participants were then sorted into two categories: High-risk or low-risk. For high-risk patients, the LHW conducted weekly telephone screenings until the patient's risk changed or death. For low-risk patients, the intervention was conducted by the LHW on a monthly basis."}], 'classes': [{'title': 'Baseline (diagnosis)', 'categories': [{'measurements': [{'value': '8.34', 'spread': '1.83', 'groupId': 'OG000'}, {'value': '8.10', 'spread': '1.80', 'groupId': 'OG001'}]}]}, {'title': '5-month follow-up', 'categories': [{'measurements': [{'value': '8.10', 'spread': '1.96', 'groupId': 'OG000'}, {'value': '9.25', 'spread': '1.03', 'groupId': 'OG001'}]}]}, {'title': 'Change at 5-months', 'categories': [{'measurements': [{'value': '-0.23', 'spread': '1.88', 'groupId': 'OG000'}, {'value': '1.15', 'spread': '1.79', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change in Patient Satisfaction with Care from baseline to 5 months.', 'description': 'Each patient will receive a satisfaction with care survey (The Consumer Assessment of Health Care Providers and Systems - General (CAHPS)) at baseline and 5 months. We will measure the change in satisfaction from calculated as the value at 5 months minus the baseline value. Scores for satisfaction were assessed using the Consumer Assessment of Healthcare Providers and Systems-General survey question #18 which measured rating of health provider, on which scores range from 0 to 10, with higher ratings correspond to higher patient satisfaction. Scores for each group are averaged at baseline and at 12 months.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control Group', 'description': 'All participants in the control group received usual cancer care provided by Oncology Institute for Hope and Innovation clinics.'}, {'id': 'FG001', 'title': 'Intervention Group', 'description': "The intervention consisted of a 12-month telephonic program in which a lay health-worker (LHW), supervised by a physician assistant, assessed patient symptoms after diagnosis using the Edmonton Symptom Assessment Scale (ESAS) Participants were then sorted into two categories: High-risk or low-risk. For high-risk patients, the LHW conducted weekly telephone screenings until the patient's risk changed or death. For low-risk patients, the intervention was conducted by the LHW on a monthly basis."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '102'}, {'groupId': 'FG001', 'numSubjects': '186'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '183'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'The study was implemented with CareMore Health and the Oncology Institute of Hope and Innovation, which has 26 locations across southern California. Enrollment was conducted between November 1, 2015 and September 30, 2016. Each patient participated for 12 months or until death, whichever occurred first.', 'preAssignmentDetails': 'Patients were excluded from the intervention and control groups if they did not require medical oncology services.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'BG000'}, {'value': '186', 'groupId': 'BG001'}, {'value': '288', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control Group', 'description': 'All participants in the control group received usual cancer care provided by Oncology Institute for Hope and Innovation clinics.'}, {'id': 'BG001', 'title': 'Intervention Group', 'description': "The intervention consisted of a 12-month telephonic program in which a lay health-worker (LHW), supervised by a physician assistant, assessed patient symptoms after diagnosis using the Edmonton Symptom Assessment Scale (ESAS) Participants were then sorted into two categories: High-risk or low-risk. For high-risk patients, the LHW conducted weekly telephone screenings until the patient's risk changed or death. For low-risk patients, the intervention was conducted by the LHW on a monthly basis."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '186', 'groupId': 'BG001'}, {'value': '288', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '79', 'spread': '7.5', 'groupId': 'BG000'}, {'value': '79', 'spread': '8.0', 'groupId': 'BG001'}, {'value': '79', 'spread': '7.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '158', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race/Ethnicity, No. (%)', 'categories': [{'title': 'Non-Hispanic White', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}]}, {'title': 'Hispanic', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}]}, {'title': 'Non-Hispanic Black', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Asian Pacific Islander', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian/Alaskan Native/American Indian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cancer Diagnosis', 'classes': [{'categories': [{'title': 'Thoracic', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'GI', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}, {'title': 'Genitourinary', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}, {'title': 'Malignant hematologic conditions', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'Breast', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'Other (i.e. skin, brain, bone, soft tissues, head/neck)', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cancer Stage', 'classes': [{'categories': [{'title': '3', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}, {'title': '4', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '170', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Cancer stages: stage 0 - the cancer is where it started (in situ) and hasn\'t spread; stage 1 - the cancer is small and hasn\'t spread anywhere else; stage 2 - the cancer has grown, but hasn\'t spread; stage 3 - the cancer is larger and may have spread to the surrounding tissues and/or the lymph nodes (or "glands", part of the immune system); stage 4 - the cancer has spread from where it started to at least 1 other body organ, also known as "secondary" or "metastatic" cancer. Stage was abstracted through chart review of clinical notes documented in the electronic health record by the oncologist.', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All newly diagnosed Medicare Advantage enrollees with stage 3 or 4 solid tumors or hematologic malignancies who were receiving care in a community oncology practice.'}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2018-03-31', 'size': 355211, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-01-23T19:17', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 288}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-06', 'studyFirstSubmitDate': '2018-11-07', 'resultsFirstSubmitDate': '2022-11-10', 'studyFirstSubmitQcDate': '2018-11-08', 'lastUpdatePostDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-06', 'studyFirstPostDateStruct': {'date': '2018-11-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Edmonton Symptom Assessment Scale Score (ESAS)', 'timeFrame': '12 months after patient enrollment', 'description': 'ESAS measures participant responses to 10 common symptoms (pain, fatigue, nausea, depression, anxiety, drowsiness, shortness of breath, appetite, sleep problems, and feeling of well-being). Participants rate the intensity of 10 symptoms, each on a 11-point scale (0 to 10); sub-scores are then summed and averaged to create a total symptom score (range: 0 to 10, with 10 corresponding to worst symptom severity).'}], 'secondaryOutcomes': [{'measure': 'Incidence of Emergency Department Visits', 'timeFrame': '12 months after patient enrollment', 'description': 'Emergency Department use for each patient abstracted from medical claims data review for each patient at 12 months after enrollment.'}, {'measure': 'Hospitalization Visits (Claims Review)', 'timeFrame': '12 months after patient enrollment', 'description': 'Hospitalization Use for each patient will be abstracted by medical claims data review for each patient at 12 months after enrollment.'}, {'measure': 'Intensive Care Unit Visits (Claims Review)', 'timeFrame': '12 months after patient enrollment', 'description': 'Intensive Care Unit Visits for each patient will be abstracted by medical claims data 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': 'Change in Patient Satisfaction With Care Using the Consumer Assessment of Health Care Providers and Systems -General Survey', 'timeFrame': 'Change in Patient Satisfaction with Care from baseline to 5 months.', 'description': 'Each patient will receive a satisfaction with care survey (The Consumer Assessment of Health Care Providers and Systems - General (CAHPS)) at baseline and 5 months. We will measure the change in satisfaction from calculated as the value at 5 months minus the baseline value. Scores for satisfaction were assessed using the Consumer Assessment of Healthcare Providers and Systems-General survey question #18 which measured rating of health provider, on which scores range from 0 to 10, with higher ratings correspond to higher patient satisfaction. Scores for each group are averaged at baseline and at 12 months.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': "Rising costs and poor patient experiences from under-treated symptoms have led to the demand for approaches that improve patients' experiences and lower expenditures. This observational project assigned a lay health worker to conduct proactive symptom assessments intended to achieve these goals among patients with advanced cancer.", 'detailedDescription': 'All newly diagnosed Medicare Advantage enrollees with Stage 3 or 4 solid tumors or hematologic malignancies who planned to receive all oncology care at the Oncology Institute of Hope and Innovation from 11/1/2015 through 9/30/2016 were enrolled in the program. The program consisted of 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) with the frequency of symptom assessment varying based on patient risk. We evaluated feasibility, defined as monthly LHW documentation of symptom assessments, and change in patient-reported satisfaction and overall and emotional and mental health with validated assessments at enrollment and 5-months post-enrollment among patients in the intervention. We compared healthcare use and costs to a historical cohort of similar Medicare Advantage enrollees diagnosed between 11/1/2014-10/31/2015 (control). We assessed differences in demographic and clinical factors between the two groups using chi-square and t-tests and used generalized linear models to evaluate differences in healthcare use and costs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients who have a diagnosis of stage 3 and 4 cancers and who are receiving care at the Oncology Institute of Hope and Innovation and have CareMore Medicare Advantage as their healthcare payer plan.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Clinical diagnosis of stage 3 and 4 cancer\n2. Clinical diagnosis of hematologic malignancy\n3. Must receive care at the Oncology Institute of Hope and Innovation\n4. Must be an enrollee of CareMore Medicare Advantage\n\nExclusion Criteria:\n\nNone'}, 'identificationModule': {'nctId': 'NCT03737058', 'briefTitle': 'Lay Health Worker Led Symptom Assessment Intervention', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Joint Oncology Collaboration for Proactive Symptom Assessments by a Lay Health Worker', 'orgStudyIdInfo': {'id': 'SU12'}}, 'armsInterventionsModule': {'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 Assessment Scale (ESAS) (cite) with the frequency of symptom assessment varying based on patient risk.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Manali Indravadan Patel', 'investigatorAffiliation': 'Stanford University'}}}}