Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-03-06 @ 5:28 PM
Study NCT ID:
NCT03892967
Status:
COMPLETED
Last Update Posted:
2025-10-07
First Post:
2019-03-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Enhanced, EHR-facilitated Cancer Symptom Control Pragmatic Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007407', 'term': 'Interviews as Topic'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Cheville.Andrea@mayo.edu', 'phone': '507-284-1402', 'title': 'Andrea L. Cheville, MD', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': "Adverse events were collected from baseline to end of study participation for up to 46 months (beginning from a participants' index medical oncology encounter until death or end of study) for all participants", 'eventGroups': [{'id': 'EG000', 'title': 'Usual Care (Control)', 'description': 'Participants were administered ePROM surveillance alone. Participants who responded to \\>=2 ePROMs were included in the analytic cohort.', 'otherNumAtRisk': 16180, 'deathsNumAtRisk': 16180, 'otherNumAffected': 0, 'seriousNumAtRisk': 16180, 'deathsNumAffected': 2214, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'EHR-facilitated Collaborative Care (Intervention)', 'description': "Participants were administered ePROMs during EHR-facilitated collaborative care (ECC) periods. Automated responses, matched to symptom type and intensity, appeared following a patient's report of an actionable symptom, defined as \\>=4/10 on a numeric rating scale (NRS). For any actionable symptom, respondents were asked if they wanted to receive symptom-specific self-management resources. For severe symptoms, \\>=7/10, respondents were asked if they wanted to work remotely with a Symptom Care Manager (SCM) to develop an individualized symptom management plan.\n\nParticipants who responded to \\>=2 ePROMs were included in the analytic cohort.", 'otherNumAtRisk': 24874, 'deathsNumAtRisk': 24874, 'otherNumAffected': 0, 'seriousNumAtRisk': 24874, 'deathsNumAffected': 3192, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Sleep Disturbance, Pain, Anxiety, Depression, Fatigue (SPADE) Symptom Scores.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16180', 'groupId': 'OG000'}, {'value': '19084', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care (Control)', 'description': 'Participants were administered ePROM surveillance alone.'}, {'id': 'OG001', 'title': 'EHR-facilitated Collaborative Care (Intervention)', 'description': "Participants were administered ePROMs during EHR-facilitated collaborative care (ECC) periods. Automated responses, matched to symptom type and intensity, appeared following a patient's report of an actionable symptom, defined as \\>=4/10 on a numeric rating scale (NRS). For any actionable symptom, respondents were asked if they wanted to receive symptom-specific self-management resources. For severe symptoms, \\>=7/10, respondents were asked if they wanted to work remotely with a Symptom Care Manager (SCM) to develop an individualized symptom management plan."}], 'classes': [{'title': 'Anxiety', 'categories': [{'measurements': [{'value': '2.09', 'groupId': 'OG000', 'lowerLimit': '2.05', 'upperLimit': '2.13'}, {'value': '1.98', 'groupId': 'OG001', 'lowerLimit': '1.94', 'upperLimit': '2.02'}]}]}, {'title': 'Depression', 'categories': [{'measurements': [{'value': '1.90', 'groupId': 'OG000', 'lowerLimit': '1.86', 'upperLimit': '1.93'}, {'value': '1.81', 'groupId': 'OG001', 'lowerLimit': '1.78', 'upperLimit': '1.85'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '3.27', 'groupId': 'OG000', 'lowerLimit': '3.22', 'upperLimit': '3.32'}, {'value': '3.21', 'groupId': 'OG001', 'lowerLimit': '3.15', 'upperLimit': '3.26'}]}]}, {'title': 'Pain', 'categories': [{'measurements': [{'value': '2.18', 'groupId': 'OG000', 'lowerLimit': '2.12', 'upperLimit': '2.24'}, {'value': '2.14', 'groupId': 'OG001', 'lowerLimit': '2.09', 'upperLimit': '2.20'}]}]}, {'title': 'Impaired Physical Function', 'categories': [{'measurements': [{'value': '2.75', 'groupId': 'OG000', 'lowerLimit': '2.69', 'upperLimit': '2.80'}, {'value': '2.78', 'groupId': 'OG001', 'lowerLimit': '2.72', 'upperLimit': '2.84'}]}]}, {'title': 'Sleep', 'categories': [{'measurements': [{'value': '2.46', 'groupId': 'OG000', 'lowerLimit': '2.41', 'upperLimit': '2.51'}, {'value': '2.39', 'groupId': 'OG001', 'lowerLimit': '2.34', 'upperLimit': '2.44'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Up to 46 months (beginning from a participants' index medical oncology encounter until death, last clinical encounter, or end of study)", 'description': 'Measured by 11-point Numeric Rating Scales (NRS) for sleep disturbance, pain, anxiety, depression, fatigue, and physical function impairment at clinic encounters. Symptoms were assessed on a scale of 0 to 10 with higher scores indicating worse outcomes.\n\nChanges in sleep disturbance, pain, anxiety, depression, fatigue, and physical function impairment from baseline score were modeled jointly as a co-primary outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analytic cohort includes trial participants who completed 2 or more NRS assessments.'}, {'type': 'PRIMARY', 'title': 'Physical Function Numerical Rating Scale (NRS) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9839', 'groupId': 'OG000'}, {'value': '13084', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care (Control)', 'description': 'Participants were administered ePROM surveillance alone.'}, {'id': 'OG001', 'title': 'EHR-facilitated Collaborative Care (Intervention)', 'description': "Participants were administered ePROMs during EHR-facilitated collaborative care (ECC) periods. Automated responses, matched to symptom type and intensity, appeared following a patient's report of an actionable symptom, defined as \\>=4/10 on a numeric rating scale (NRS). For any actionable symptom, respondents were asked if they wanted to receive symptom-specific self-management resources. For severe symptoms, \\>=7/10, respondents were asked if they wanted to work remotely with a Symptom Care Manager (SCM) to develop an individualized symptom management plan."}], 'classes': [{'title': 'Anxiety', 'categories': [{'measurements': [{'value': '2.51', 'groupId': 'OG000', 'lowerLimit': '2.05', 'upperLimit': '2.63'}, {'value': '2.37', 'groupId': 'OG001', 'lowerLimit': '2.24', 'upperLimit': '2.49'}]}]}, {'title': 'Depression', 'categories': [{'measurements': [{'value': '2.27', 'groupId': 'OG000', 'lowerLimit': '2.14', 'upperLimit': '2.40'}, {'value': '2.17', 'groupId': 'OG001', 'lowerLimit': '2.04', 'upperLimit': '2.30'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '3.96', 'groupId': 'OG000', 'lowerLimit': '3.80', 'upperLimit': '4.12'}, {'value': '3.87', 'groupId': 'OG001', 'lowerLimit': '3.72', 'upperLimit': '4.03'}]}]}, {'title': 'Pain', 'categories': [{'measurements': [{'value': '2.53', 'groupId': 'OG000', 'lowerLimit': '2.37', 'upperLimit': '2.69'}, {'value': '2.55', 'groupId': 'OG001', 'lowerLimit': '2.39', 'upperLimit': '2.70'}]}]}, {'title': 'Physical function impairment', 'categories': [{'measurements': [{'value': '3.23', 'groupId': 'OG000', 'lowerLimit': '3.05', 'upperLimit': '3.42'}, {'value': '3.30', 'groupId': 'OG001', 'lowerLimit': '3.11', 'upperLimit': '3.48'}]}]}, {'title': 'Sleep', 'categories': [{'measurements': [{'value': '2.91', 'groupId': 'OG000', 'lowerLimit': '2.75', 'upperLimit': '3.06'}, {'value': '2.85', 'groupId': 'OG001', 'lowerLimit': '2.70', 'upperLimit': '3.01'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Up to 46 months (beginning from a participants' index medical oncology encounter until death, last clinical encounter, or end of study)", 'description': 'Measured by 11-point Numeric Rating Scales (NRS) for sleep disturbance, pain, anxiety, depression, fatigue, and physical function impairment at clinic encounters. Symptoms were assessed on a scale of 0 to 10 with higher scores indicating worse outcomes.\n\nChanges in sleep disturbance, pain, anxiety, depression, fatigue, and physical function impairment following any NRS score of \\>=4/10 modeled jointly as a co-primary outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analytic cohort includes trial participants who completed 2 or more NRS assessments and reported at least 1 NRS score \\>= 4/10'}, {'type': 'SECONDARY', 'title': 'Change in Anxiety Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19952', 'groupId': 'OG000'}, {'value': '25970', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care (Control)', 'description': 'Participants were administered ePROM surveillance alone.'}, {'id': 'OG001', 'title': 'EHR-facilitated Collaborative Care (Intervention)', 'description': "Participants were administered ePROMs during EHR-facilitated collaborative care (ECC) periods. Automated responses, matched to symptom type and intensity, appeared following a patient's report of an actionable symptom, defined as \\>=4/10 on a numeric rating scale (NRS). For any actionable symptom, respondents were asked if they wanted to receive symptom-specific self-management resources. For severe symptoms, \\>=7/10, respondents were asked if they wanted to work remotely with a Symptom Care Manager (SCM) to develop an individualized symptom management plan."}], 'classes': [{'categories': [{'measurements': [{'value': '51.86451', 'spread': '9.036415', 'groupId': 'OG000'}, {'value': '51.35445', 'spread': '9.303022', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 46 months', 'description': 'Measured PROMIS-CAT T-scores up to every four months, depending on visit frequency. A T-score of 50 represents the average score for the U.S. general population, with a standard deviation of 10. A higher score indicates a worse outcome. PROMIS-CAT T-scores were averaged for the control and intervention periods.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who answered \\>=1 Anxiety PROMIS-CAT were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change in Depression Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19979', 'groupId': 'OG000'}, {'value': '25498', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care (Control)', 'description': 'Participants were administered ePROM surveillance alone.'}, {'id': 'OG001', 'title': 'EHR-facilitated Collaborative Care (Intervention)', 'description': "Participants were administered ePROMs during EHR-facilitated collaborative care (ECC) periods. Automated responses, matched to symptom type and intensity, appeared following a patient's report of an actionable symptom, defined as \\>=4/10 on a numeric rating scale (NRS). For any actionable symptom, respondents were asked if they wanted to receive symptom-specific self-management resources. For severe symptoms, \\>=7/10, respondents were asked if they wanted to work remotely with a Symptom Care Manager (SCM) to develop an individualized symptom management plan."}], 'classes': [{'categories': [{'measurements': [{'value': '49.05267', 'spread': '8.642265', 'groupId': 'OG000'}, {'value': '48.49032', 'spread': '8.666607', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 46 months', 'description': 'Measured PROMIS-CAT T-score up to every four months, depending on visit frequency. A T-score of 50 represents the average score for the U.S. general population, with a standard deviation of 10. A higher score indicates a worse outcome. PROMIS-CAT T-scores were averaged for the control and intervention periods.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who answered \\>=1 Depression PROMIS-CAT were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change in Average Pain Interference Over the Past Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20225', 'groupId': 'OG000'}, {'value': '26516', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care (Control)', 'description': 'Participants were administered ePROM surveillance alone.'}, {'id': 'OG001', 'title': 'EHR-facilitated Collaborative Care (Intervention)', 'description': "Participants were administered ePROMs during EHR-facilitated collaborative care (ECC) periods. Automated responses, matched to symptom type and intensity, appeared following a patient's report of an actionable symptom, defined as \\>=4/10 on a numeric rating scale (NRS). For any actionable symptom, respondents were asked if they wanted to receive symptom-specific self-management resources. For severe symptoms, \\>=7/10, respondents were asked if they wanted to work remotely with a Symptom Care Manager (SCM) to develop an individualized symptom management plan."}], 'classes': [{'categories': [{'measurements': [{'value': '52.57027', 'spread': '9.80923', 'groupId': 'OG000'}, {'value': '53.2717', 'spread': '9.918807', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 46 months', 'description': 'Measured PROMIS-CAT T-score up to every four months, depending on visit frequency. A T-score of 50 represents the average score for the U.S. general population, with a standard deviation of 10. A higher score indicates a worse outcome. PROMIS-CAT T-scores were averaged for the control and intervention periods.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who answered \\>=1 Pain Interference PROMIS-CAT were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change in Physical Function Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20070', 'groupId': 'OG000'}, {'value': '26239', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care (Control)', 'description': 'Participants were administered ePROM surveillance alone.'}, {'id': 'OG001', 'title': 'EHR-facilitated Collaborative Care (Intervention)', 'description': "Participants were administered ePROMs during EHR-facilitated collaborative care (ECC) periods. Automated responses, matched to symptom type and intensity, appeared following a patient's report of an actionable symptom, defined as \\>=4/10 on a numeric rating scale (NRS). For any actionable symptom, respondents were asked if they wanted to receive symptom-specific self-management resources. For severe symptoms, \\>=7/10, respondents were asked if they wanted to work remotely with a Symptom Care Manager (SCM) to develop an individualized symptom management plan."}], 'classes': [{'categories': [{'measurements': [{'value': '43.83007', 'spread': '9.641792', 'groupId': 'OG000'}, {'value': '43.18325', 'spread': '9.561469', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 46 months', 'description': 'Measured PROMIS-CAT up to every four months, depending on visit frequency. A T-score of 50 represents the average score for the U.S. general population, with a standard deviation of 10. A higher score indicates a better outcome. PROMIS-CAT T-scores were averaged for the control and intervention periods.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who answered \\>=1 Physical Function PROMIS-CAT were analyzed.'}, {'type': 'SECONDARY', 'title': 'Health Care Utilization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13090', 'groupId': 'OG000'}, {'value': '15220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care (Control)', 'description': 'Participants were administered ePROM surveillance alone.'}, {'id': 'OG001', 'title': 'EHR-facilitated Collaborative Care (Intervention)', 'description': "Participants were administered ePROMs during EHR-facilitated collaborative care (ECC) periods. Automated responses, matched to symptom type and intensity, appeared following a patient's report of an actionable symptom, defined as \\>=4/10 on a numeric rating scale (NRS). For any actionable symptom, respondents were asked if they wanted to receive symptom-specific self-management resources. For severe symptoms, \\>=7/10, respondents were asked if they wanted to work remotely with a Symptom Care Manager (SCM) to develop an individualized symptom management plan."}], 'classes': [{'title': 'Hospitalizations', 'categories': [{'measurements': [{'value': '3415', 'groupId': 'OG000'}, {'value': '3009', 'groupId': 'OG001'}]}]}, {'title': 'ED visits', 'categories': [{'measurements': [{'value': '4331', 'groupId': 'OG000'}, {'value': '3495', 'groupId': 'OG001'}]}]}, {'title': 'ICU admissions', 'categories': [{'measurements': [{'value': '940', 'groupId': 'OG000'}, {'value': '722', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "Up to 46 months (beginning from a participants' index medical oncology encounter until death, 18 months after last clinical encounter, or end of study)", 'description': 'ER visits, hospitalizations, and ICU admissions', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED', 'populationDescription': 'Utilization data were available for the entire E2C2 trial cohort irrespective of ePROM completion. To assess robustness, we conducted analyses that included the full cohort, the \\>=1 ePROM completers, and the \\>=2 ePROM completers. In addition, we created subgroups based on residential proximity to a trial site to assess the extent of care provided at non-participating institutions. Here we report the patients who completed 1 or more surveys and resided within 120 miles from a trial site.'}, {'type': 'SECONDARY', 'title': 'Adherence to Cancer Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care (Control)', 'description': 'Participants were administered ePROM surveillance alone.'}, {'id': 'OG001', 'title': 'EHR-facilitated Collaborative Care (Intervention)', 'description': "Participants were administered ePROMs during EHR-facilitated collaborative care (ECC) periods. Automated responses, matched to symptom type and intensity, appeared following a patient's report of an actionable symptom, defined as \\>=4/10 on a numeric rating scale (NRS). For any actionable symptom, respondents were asked if they wanted to receive symptom-specific self-management resources. For severe symptoms, \\>=7/10, respondents were asked if they wanted to work remotely with a Symptom Care Manager (SCM) to develop an individualized symptom management plan."}], 'classes': [{'title': 'Number of doses of docetaxel administered', 'categories': [{'measurements': [{'value': '3.530303', 'spread': '1.088281', 'groupId': 'OG000'}, {'value': '3.765625', 'spread': '0.6458148', 'groupId': 'OG001'}]}]}, {'title': 'Number of doses of cyclophosphamide administered', 'categories': [{'measurements': [{'value': '3.707071', 'spread': '0.973151', 'groupId': 'OG000'}, {'value': '3.78125', 'spread': '0.7310601', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Up to 46 months (beginning from a participants' index medical oncology encounter until death or end of study)", 'description': 'Number of doses of docetaxel and cyclophosphamide administered.', 'unitOfMeasure': 'number of doses administered', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were restricted to the subgroup of patients with breast cancer being treated with docetaxel/cyclophosphamide in order to ensure comparable receipt of chemotherapeutic regimens between the comparator groups. Because docetaxel and cyclophosphamide may be first-/second-line therapy for breast cancer, a large participant subgroup that offered adequate power was chosen. Patients who crossed over from usual care to EHR-facilitated collaborative care were excluded from this analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Deceased Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16180', 'groupId': 'OG000'}, {'value': '24874', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care (Control)', 'description': 'Participants were administered ePROM surveillance alone.'}, {'id': 'OG001', 'title': 'EHR-facilitated Collaborative Care (Intervention)', 'description': "Participants were administered ePROMs during EHR-facilitated collaborative care (ECC) periods. Automated responses, matched to symptom type and intensity, appeared following a patient's report of an actionable symptom, defined as \\>=4/10 on a numeric rating scale (NRS). For any actionable symptom, respondents were asked if they wanted to receive symptom-specific self-management resources. For severe symptoms, \\>=7/10, respondents were asked if they wanted to work remotely with a Symptom Care Manager (SCM) to develop an individualized symptom management plan."}], 'classes': [{'categories': [{'measurements': [{'value': '2214', 'groupId': 'OG000'}, {'value': '3192', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': "Up to 46 months (beginning from a participants' index medical oncology encounter until death or end of study)", 'description': 'Vital status (living or deceased) was determined by Accurint record search across multiple sources, including the Social Security Death Index', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sequence 1', 'description': 'Sequence 1 began usual care on 4/1/2019 and entered EHR-facilitated collaborative care starting on 10/1/2019 (Step 2) until end of study on 1/31/2023'}, {'id': 'FG001', 'title': 'Sequence 2', 'description': 'Sequence 2 began usual care on 4/1/2019 and entered EHR-facilitated collaborative care starting on 6/1/2020 (Step 3) until end of study on 1/31/2023'}, {'id': 'FG002', 'title': 'Sequence 3', 'description': 'Sequence 3 began usual care on 4/1/2019 and entered EHR-facilitated collaborative care starting on 2/1/2021 (Step 4) until end of study on 1/31/2023'}, {'id': 'FG003', 'title': 'Sequence 4', 'description': 'Sequence 4 began usual care on 4/1/2019 and entered EHR-facilitated collaborative care starting on 10/1/2021 (Step 5) until end of study on 1/31/2023'}, {'id': 'FG004', 'title': 'Sequence 5', 'description': 'Sequence 5 began usual care on 4/1/2019 and entered EHR-facilitated collaborative care starting on 6/1/2022 (Step 6) until end of study on 1/31/2023'}], 'periods': [{'title': 'Step 1: 4/1/2019-9/30/2019', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '3', 'numSubjects': '2709'}, {'groupId': 'FG001', 'numUnits': '3', 'numSubjects': '4023'}, {'groupId': 'FG002', 'numUnits': '3', 'numSubjects': '4353'}, {'groupId': 'FG003', 'numUnits': '3', 'numSubjects': '3724'}, {'groupId': 'FG004', 'numUnits': '3', 'numSubjects': '1906'}]}, {'type': 'Answered >=1 Electronic Patient Reported Outcome Measure', 'achievements': [{'groupId': 'FG000', 'numUnits': '3', 'numSubjects': '1992'}, {'groupId': 'FG001', 'numUnits': '3', 'numSubjects': '3098'}, {'groupId': 'FG002', 'numUnits': '3', 'numSubjects': '3314'}, {'groupId': 'FG003', 'numUnits': '3', 'numSubjects': '2967'}, {'groupId': 'FG004', 'numUnits': '3', 'numSubjects': '1467'}]}, {'type': 'Answered >=2 Electronic Patient Reported Outcome Measures', 'comment': 'Analytic cohort: this subgroup was exposed to the full intervention and the effect of exposure could be assessed', 'achievements': [{'groupId': 'FG000', 'numUnits': '3', 'numSubjects': '1426'}, {'groupId': 'FG001', 'numUnits': '3', 'numSubjects': '2295'}, {'groupId': 'FG002', 'numUnits': '3', 'numSubjects': '2530'}, {'groupId': 'FG003', 'numUnits': '3', 'numSubjects': '2281'}, {'groupId': 'FG004', 'numUnits': '3', 'numSubjects': '1178'}]}, {'type': 'COMPLETED', 'comment': 'Trial participants who responded to at least two electronic patients reported outcome measures (ePROMs) were included in the primary analysis. We list those patients here as "completed." However, participants who completed one or more ePROMs were also included in secondary analyses evaluating individual symptom scores. Additionally, the entire trial cohort (N=50,207) were included in secondary utilization and survival analyses.', 'achievements': [{'groupId': 'FG000', 'numUnits': '3', 'numSubjects': '1426'}, {'groupId': 'FG001', 'numUnits': '3', 'numSubjects': '2295'}, {'groupId': 'FG002', 'numUnits': '3', 'numSubjects': '2530'}, {'groupId': 'FG003', 'numUnits': '3', 'numSubjects': '2281'}, {'groupId': 'FG004', 'numUnits': '3', 'numSubjects': '1178'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '1283'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '1728'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '1823'}, {'groupId': 'FG003', 'numUnits': '0', 'numSubjects': '1443'}, {'groupId': 'FG004', 'numUnits': '0', 'numSubjects': '728'}]}], 'dropWithdraws': [{'type': 'Participants did not answer at least two surveys and were not included in the analytic cohort', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1283'}, {'groupId': 'FG001', 'numSubjects': '1728'}, {'groupId': 'FG002', 'numSubjects': '1823'}, {'groupId': 'FG003', 'numSubjects': '1443'}, {'groupId': 'FG004', 'numSubjects': '728'}]}]}, {'title': 'Step 2: 10/1/2019-5/31/2020', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '3', 'numSubjects': '1877'}, {'groupId': 'FG001', 'numUnits': '3', 'numSubjects': '2846'}, {'groupId': 'FG002', 'numUnits': '3', 'numSubjects': '3490'}, {'groupId': 'FG003', 'numUnits': '3', 'numSubjects': '2696'}, {'groupId': 'FG004', 'numUnits': '3', 'numSubjects': '1599'}]}, {'type': 'Answered >=1 Electronic Patient Reported Outcome Measure', 'achievements': [{'groupId': 'FG000', 'numUnits': '3', 'numSubjects': '1615'}, {'groupId': 'FG001', 'numUnits': '3', 'numSubjects': '2420'}, {'groupId': 'FG002', 'numUnits': '3', 'numSubjects': '3121'}, {'groupId': 'FG003', 'numUnits': '3', 'numSubjects': '2382'}, {'groupId': 'FG004', 'numUnits': '3', 'numSubjects': '1445'}]}, {'type': 'Answered >=2 Electronic Patient Reported Outcome Measures', 'comment': 'Analytic cohort: this subgroup was exposed to the full intervention and the effect of exposure could be assessed', 'achievements': [{'groupId': 'FG000', 'numUnits': '3', 'numSubjects': '1403'}, {'groupId': 'FG001', 'numUnits': '3', 'numSubjects': '2120'}, {'groupId': 'FG002', 'numUnits': '3', 'numSubjects': '2716'}, {'groupId': 'FG003', 'numUnits': '3', 'numSubjects': '2144'}, {'groupId': 'FG004', 'numUnits': '3', 'numSubjects': '1233'}]}, {'type': 'COMPLETED', 'comment': 'Trial participants who responded to at least two electronic patients reported outcome measures (ePROMs) were included in the primary analysis. We list those patients here as "completed." However, participants who completed one or more ePROMs were also included in secondary analyses evaluating individual symptom scores. Additionally, the entire trial cohort (N=50,207) were included in secondary utilization and survival analyses.', 'achievements': [{'groupId': 'FG000', 'numUnits': '3', 'numSubjects': '1403'}, {'groupId': 'FG001', 'numUnits': '3', 'numSubjects': '2120'}, {'groupId': 'FG002', 'numUnits': '3', 'numSubjects': '2716'}, {'groupId': 'FG003', 'numUnits': '3', 'numSubjects': '2144'}, {'groupId': 'FG004', 'numUnits': '3', 'numSubjects': '1233'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '474'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '726'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '774'}, {'groupId': 'FG003', 'numUnits': '0', 'numSubjects': '552'}, {'groupId': 'FG004', 'numUnits': '0', 'numSubjects': '366'}]}], 'dropWithdraws': [{'type': 'Participants did not answer at least two surveys and were not included in the analytic cohort', 'reasons': [{'groupId': 'FG000', 'numSubjects': '474'}, {'groupId': 'FG001', 'numSubjects': '726'}, {'groupId': 'FG002', 'numSubjects': '774'}, {'groupId': 'FG003', 'numSubjects': '552'}, {'groupId': 'FG004', 'numSubjects': '366'}]}]}, {'title': 'Step 3: 6/1/2020-1/31/2021', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '3', 'numSubjects': '2360'}, {'groupId': 'FG001', 'numUnits': '3', 'numSubjects': '3566'}, {'groupId': 'FG002', 'numUnits': '3', 'numSubjects': '4516'}, {'groupId': 'FG003', 'numUnits': '3', 'numSubjects': '3552'}, {'groupId': 'FG004', 'numUnits': '3', 'numSubjects': '1541'}]}, {'type': 'Answered >=1 Electronic Patient Reported Outcome Measure', 'achievements': [{'groupId': 'FG000', 'numUnits': '3', 'numSubjects': '2047'}, {'groupId': 'FG001', 'numUnits': '3', 'numSubjects': '3058'}, {'groupId': 'FG002', 'numUnits': '3', 'numSubjects': '4121'}, {'groupId': 'FG003', 'numUnits': '3', 'numSubjects': '3221'}, {'groupId': 'FG004', 'numUnits': '3', 'numSubjects': '1413'}]}, {'type': 'Answered >=2 Electronic Patient Reported Outcome Measures', 'comment': 'Analytic cohort: this subgroup was exposed to the full intervention and the effect of exposure could be assessed', 'achievements': [{'groupId': 'FG000', 'numUnits': '3', 'numSubjects': '1650'}, {'groupId': 'FG001', 'numUnits': '3', 'numSubjects': '2573'}, {'groupId': 'FG002', 'numUnits': '3', 'numSubjects': '3606'}, {'groupId': 'FG003', 'numUnits': '3', 'numSubjects': '2813'}, {'groupId': 'FG004', 'numUnits': '3', 'numSubjects': '1261'}]}, {'type': 'COMPLETED', 'comment': 'Trial participants who responded to at least two electronic patients reported outcome measures (ePROMs) were included in the primary analysis. We list those patients here as "completed." However, participants who completed one or more ePROMs were also included in secondary analyses evaluating individual symptom scores. Additionally, the entire trial cohort (N=50,207) were included in secondary utilization and survival analyses.', 'achievements': [{'groupId': 'FG000', 'numUnits': '3', 'numSubjects': '1650'}, {'groupId': 'FG001', 'numUnits': '3', 'numSubjects': '2573'}, {'groupId': 'FG002', 'numUnits': '3', 'numSubjects': '3606'}, {'groupId': 'FG003', 'numUnits': '3', 'numSubjects': '2813'}, {'groupId': 'FG004', 'numUnits': '3', 'numSubjects': '1261'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '710'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '993'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '910'}, {'groupId': 'FG003', 'numUnits': '0', 'numSubjects': '739'}, {'groupId': 'FG004', 'numUnits': '0', 'numSubjects': '280'}]}], 'dropWithdraws': [{'type': 'Participants did not answer at least two surveys and were not included in the analytic cohort', 'reasons': [{'groupId': 'FG000', 'numSubjects': '710'}, {'groupId': 'FG001', 'numSubjects': '993'}, {'groupId': 'FG002', 'numSubjects': '910'}, {'groupId': 'FG003', 'numSubjects': '739'}, {'groupId': 'FG004', 'numSubjects': '280'}]}]}, {'title': 'Step 4: 2/1/2021-9/30/2021', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '3', 'numSubjects': '1954'}, {'groupId': 'FG001', 'numUnits': '3', 'numSubjects': '3468'}, {'groupId': 'FG002', 'numUnits': '3', 'numSubjects': '4626'}, {'groupId': 'FG003', 'numUnits': '3', 'numSubjects': '3606'}, {'groupId': 'FG004', 'numUnits': '3', 'numSubjects': '1472'}]}, {'type': 'Answered >=1 Electronic Patient Reported Outcome Measure', 'achievements': [{'groupId': 'FG000', 'numUnits': '3', 'numSubjects': '1660'}, {'groupId': 'FG001', 'numUnits': '3', 'numSubjects': '3028'}, {'groupId': 'FG002', 'numUnits': '3', 'numSubjects': '4259'}, {'groupId': 'FG003', 'numUnits': '3', 'numSubjects': '3273'}, {'groupId': 'FG004', 'numUnits': '3', 'numSubjects': '1328'}]}, {'type': 'Answered >=2 Electronic Patient Reported Outcome Measures', 'comment': 'Analytic cohort: this subgroup was exposed to the full intervention and the effect of exposure could be assessed', 'achievements': [{'groupId': 'FG000', 'numUnits': '3', 'numSubjects': '1369'}, {'groupId': 'FG001', 'numUnits': '3', 'numSubjects': '2575'}, {'groupId': 'FG002', 'numUnits': '3', 'numSubjects': '3664'}, {'groupId': 'FG003', 'numUnits': '3', 'numSubjects': '2776'}, {'groupId': 'FG004', 'numUnits': '3', 'numSubjects': '1157'}]}, {'type': 'COMPLETED', 'comment': 'Trial participants who responded to at least two electronic patients reported outcome measures (ePROMs) were included in the primary analysis. We list those patients here as "completed." However, participants who completed one or more ePROMs were also included in secondary analyses evaluating individual symptom scores. Additionally, the entire trial cohort (N=50,207) were included in secondary utilization and survival analyses.', 'achievements': [{'groupId': 'FG000', 'numUnits': '3', 'numSubjects': '1369'}, {'groupId': 'FG001', 'numUnits': '3', 'numSubjects': '2575'}, {'groupId': 'FG002', 'numUnits': '3', 'numSubjects': '3664'}, {'groupId': 'FG003', 'numUnits': '3', 'numSubjects': '2776'}, {'groupId': 'FG004', 'numUnits': '3', 'numSubjects': '1157'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '585'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '893'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '962'}, {'groupId': 'FG003', 'numUnits': '0', 'numSubjects': '830'}, {'groupId': 'FG004', 'numUnits': '0', 'numSubjects': '315'}]}], 'dropWithdraws': [{'type': 'Participants did not answer at least two surveys and were not included in the analytic cohort', 'reasons': [{'groupId': 'FG000', 'numSubjects': '585'}, {'groupId': 'FG001', 'numSubjects': '893'}, {'groupId': 'FG002', 'numSubjects': '962'}, {'groupId': 'FG003', 'numSubjects': '830'}, {'groupId': 'FG004', 'numSubjects': '315'}]}]}, {'title': 'Step 5: 10/1/2021-5/31/2022', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '3', 'numSubjects': '1859'}, {'groupId': 'FG001', 'numUnits': '3', 'numSubjects': '3185'}, {'groupId': 'FG002', 'numUnits': '3', 'numSubjects': '4504'}, {'groupId': 'FG003', 'numUnits': '3', 'numSubjects': '3796'}, {'groupId': 'FG004', 'numUnits': '3', 'numSubjects': '1303'}]}, {'type': 'Answered >=1 Electronic Patient Reported Outcome Measure', 'achievements': [{'groupId': 'FG000', 'numUnits': '3', 'numSubjects': '1639'}, {'groupId': 'FG001', 'numUnits': '3', 'numSubjects': '2796'}, {'groupId': 'FG002', 'numUnits': '3', 'numSubjects': '4119'}, {'groupId': 'FG003', 'numUnits': '3', 'numSubjects': '3495'}, {'groupId': 'FG004', 'numUnits': '3', 'numSubjects': '1161'}]}, {'type': 'Answered >=2 Electronic Patient Reported Outcome Measures', 'comment': 'Analytic cohort: this subgroup was exposed to the full intervention and the effect of exposure could be assessed', 'achievements': [{'groupId': 'FG000', 'numUnits': '3', 'numSubjects': '1351'}, {'groupId': 'FG001', 'numUnits': '3', 'numSubjects': '2340'}, {'groupId': 'FG002', 'numUnits': '3', 'numSubjects': '3479'}, {'groupId': 'FG003', 'numUnits': '3', 'numSubjects': '3045'}, {'groupId': 'FG004', 'numUnits': '3', 'numSubjects': '1001'}]}, {'type': 'COMPLETED', 'comment': 'Trial participants who responded to at least two electronic patients reported outcome measures (ePROMs) were included in the primary analysis. We list those patients here as "completed." However, participants who completed one or more ePROMs were also included in secondary analyses evaluating individual symptom scores. Additionally, the entire trial cohort (N=50,207) were included in secondary utilization and survival analyses.', 'achievements': [{'groupId': 'FG000', 'numUnits': '3', 'numSubjects': '1351'}, {'groupId': 'FG001', 'numUnits': '3', 'numSubjects': '2340'}, {'groupId': 'FG002', 'numUnits': '3', 'numSubjects': '3479'}, {'groupId': 'FG003', 'numUnits': '3', 'numSubjects': '3045'}, {'groupId': 'FG004', 'numUnits': '3', 'numSubjects': '1001'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '508'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '845'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '1025'}, {'groupId': 'FG003', 'numUnits': '0', 'numSubjects': '751'}, {'groupId': 'FG004', 'numUnits': '0', 'numSubjects': '302'}]}], 'dropWithdraws': [{'type': 'Participants did not answer at least two surveys and were not included in the analytic cohort', 'reasons': [{'groupId': 'FG000', 'numSubjects': '508'}, {'groupId': 'FG001', 'numSubjects': '845'}, {'groupId': 'FG002', 'numSubjects': '1025'}, {'groupId': 'FG003', 'numSubjects': '751'}, {'groupId': 'FG004', 'numSubjects': '302'}]}]}, {'title': 'Step 6: 6/1/2022-1/31/2023', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '3', 'numSubjects': '2206'}, {'groupId': 'FG001', 'numUnits': '3', 'numSubjects': '3208'}, {'groupId': 'FG002', 'numUnits': '3', 'numSubjects': '4668'}, {'groupId': 'FG003', 'numUnits': '3', 'numSubjects': '3804'}, {'groupId': 'FG004', 'numUnits': '3', 'numSubjects': '1541'}]}, {'type': 'Answered >=1 Electronic Patient Reported Outcome Measure', 'achievements': [{'groupId': 'FG000', 'numUnits': '3', 'numSubjects': '1940'}, {'groupId': 'FG001', 'numUnits': '3', 'numSubjects': '2828'}, {'groupId': 'FG002', 'numUnits': '3', 'numSubjects': '4233'}, {'groupId': 'FG003', 'numUnits': '3', 'numSubjects': '3487'}, {'groupId': 'FG004', 'numUnits': '3', 'numSubjects': '1329'}]}, {'type': 'Answered >=2 Electronic Patient Reported Outcome Measures', 'comment': 'Analytic cohort: this subgroup was exposed to the full intervention and the effect of exposure could be assessed', 'achievements': [{'groupId': 'FG000', 'numUnits': '3', 'numSubjects': '1409'}, {'groupId': 'FG001', 'numUnits': '3', 'numSubjects': '2031'}, {'groupId': 'FG002', 'numUnits': '3', 'numSubjects': '3270'}, {'groupId': 'FG003', 'numUnits': '3', 'numSubjects': '2735'}, {'groupId': 'FG004', 'numUnits': '3', 'numSubjects': '1055'}]}, {'type': 'COMPLETED', 'comment': 'Trial participants who responded to at least two electronic patients reported outcome measures (ePROMs) were included in the primary analysis. We list those patients here as "completed." However, participants who completed one or more ePROMs were also included in secondary analyses evaluating individual symptom scores. Additionally, the entire trial cohort (N=50,207) were included in secondary utilization and survival analyses.', 'achievements': [{'groupId': 'FG000', 'numUnits': '3', 'numSubjects': '1409'}, {'groupId': 'FG001', 'numUnits': '3', 'numSubjects': '2031'}, {'groupId': 'FG002', 'numUnits': '3', 'numSubjects': '3270'}, {'groupId': 'FG003', 'numUnits': '3', 'numSubjects': '2735'}, {'groupId': 'FG004', 'numUnits': '3', 'numSubjects': '1055'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '797'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '1177'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '1398'}, {'groupId': 'FG003', 'numUnits': '0', 'numSubjects': '1069'}, {'groupId': 'FG004', 'numUnits': '0', 'numSubjects': '486'}]}], 'dropWithdraws': [{'type': 'Participants did not answer at least two surveys and were not included in the analytic cohort', 'reasons': [{'groupId': 'FG000', 'numSubjects': '797'}, {'groupId': 'FG001', 'numSubjects': '1177'}, {'groupId': 'FG002', 'numSubjects': '1398'}, {'groupId': 'FG003', 'numSubjects': '1069'}, {'groupId': 'FG004', 'numSubjects': '486'}]}]}], 'typeUnitsAnalyzed': 'Clusters (provider groups)', 'recruitmentDetails': 'From March 2019 to January 2023, 50,207 patients (in fifteen clusters) were enrolled and administered ePROMs in association with oncology visits.', 'preAssignmentDetails': 'Participants could be enrolled for more than one Period over the course of the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16180', 'groupId': 'BG000'}, {'value': '19084', 'groupId': 'BG001'}, {'value': '35264', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Usual Care (Control)', 'description': 'Participants were administered ePROM surveillance alone.'}, {'id': 'BG001', 'title': 'EHR-facilitated Collaborative Care (Intervention)', 'description': "Participants were administered ePROMs during EHR-facilitated collaborative care (ECC) periods. Automated responses, matched to symptom type and intensity, appeared following a patient's report of an actionable symptom, defined as \\>=4/10 on a numeric rating scale (NRS). For any actionable symptom, respondents were asked if they wanted to receive symptom-specific self-management resources. For severe symptoms, \\>=7/10, respondents were asked if they wanted to work remotely with a Symptom Care Manager (SCM) to develop an individualized symptom management plan."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age', 'categories': [{'title': '<=35', 'measurements': [{'value': '566', 'groupId': 'BG000'}, {'value': '646', 'groupId': 'BG001'}, {'value': '1212', 'groupId': 'BG002'}]}, {'title': '35-45', 'measurements': [{'value': '1200', 'groupId': 'BG000'}, {'value': '1514', 'groupId': 'BG001'}, {'value': '2714', 'groupId': 'BG002'}]}, {'title': '45-55', 'measurements': [{'value': '2336', 'groupId': 'BG000'}, {'value': '2877', 'groupId': 'BG001'}, {'value': '5213', 'groupId': 'BG002'}]}, {'title': '55-65', 'measurements': [{'value': '4188', 'groupId': 'BG000'}, {'value': '4993', 'groupId': 'BG001'}, {'value': '9181', 'groupId': 'BG002'}]}, {'title': '65-75', 'measurements': [{'value': '4933', 'groupId': 'BG000'}, {'value': '5871', 'groupId': 'BG001'}, {'value': '10804', 'groupId': 'BG002'}]}, {'title': '75-85', 'measurements': [{'value': '2466', 'groupId': 'BG000'}, {'value': '2689', 'groupId': 'BG001'}, {'value': '5155', 'groupId': 'BG002'}]}, {'title': '>85', 'measurements': [{'value': '491', 'groupId': 'BG000'}, {'value': '494', 'groupId': 'BG001'}, {'value': '985', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9621', 'groupId': 'BG000'}, {'value': '11138', 'groupId': 'BG001'}, {'value': '20759', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6559', 'groupId': 'BG000'}, {'value': '7946', 'groupId': 'BG001'}, {'value': '14505', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '15982', 'groupId': 'BG000'}, {'value': '18816', 'groupId': 'BG001'}, {'value': '34798', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '134', 'groupId': 'BG000'}, {'value': '189', 'groupId': 'BG001'}, {'value': '323', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '248', 'groupId': 'BG000'}, {'value': '357', 'groupId': 'BG001'}, {'value': '605', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '149', 'groupId': 'BG000'}, {'value': '180', 'groupId': 'BG001'}, {'value': '329', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '15468', 'groupId': 'BG000'}, {'value': '18189', 'groupId': 'BG001'}, {'value': '33657', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '246', 'groupId': 'BG000'}, {'value': '266', 'groupId': 'BG001'}, {'value': '512', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '16180', 'groupId': 'BG000'}, {'value': '19084', 'groupId': 'BG001'}, {'value': '35264', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'The accurate number of baseline participants in the analytic cohort is 24874. This is because 10390 participants contributed to both Usual Care and EHR-facilitated Collaborative Care. The numbers in the usual care (control) and EHR-facilitated collaborative care (intervention) columns accurately reflect the participants who contributed data to the comparator conditions. Unfortunately, we cannot make this distinction in the "total" column which is automatically calculated.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-03-04', 'size': 609690, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_020.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-04-09T11:19', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50207}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-17', 'studyFirstSubmitDate': '2019-03-19', 'resultsFirstSubmitDate': '2025-03-14', 'studyFirstSubmitQcDate': '2019-03-25', 'lastUpdatePostDateStruct': {'date': '2025-10-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-09-17', 'studyFirstPostDateStruct': {'date': '2019-03-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sleep Disturbance, Pain, Anxiety, Depression, Fatigue (SPADE) Symptom Scores.', 'timeFrame': "Up to 46 months (beginning from a participants' index medical oncology encounter until death, last clinical encounter, or end of study)", 'description': 'Measured by 11-point Numeric Rating Scales (NRS) for sleep disturbance, pain, anxiety, depression, fatigue, and physical function impairment at clinic encounters. Symptoms were assessed on a scale of 0 to 10 with higher scores indicating worse outcomes.\n\nChanges in sleep disturbance, pain, anxiety, depression, fatigue, and physical function impairment from baseline score were modeled jointly as a co-primary outcome.'}, {'measure': 'Physical Function Numerical Rating Scale (NRS) Scores', 'timeFrame': "Up to 46 months (beginning from a participants' index medical oncology encounter until death, last clinical encounter, or end of study)", 'description': 'Measured by 11-point Numeric Rating Scales (NRS) for sleep disturbance, pain, anxiety, depression, fatigue, and physical function impairment at clinic encounters. Symptoms were assessed on a scale of 0 to 10 with higher scores indicating worse outcomes.\n\nChanges in sleep disturbance, pain, anxiety, depression, fatigue, and physical function impairment following any NRS score of \\>=4/10 modeled jointly as a co-primary outcome.'}], 'secondaryOutcomes': [{'measure': 'Change in Anxiety Score', 'timeFrame': 'Baseline to 46 months', 'description': 'Measured PROMIS-CAT T-scores up to every four months, depending on visit frequency. A T-score of 50 represents the average score for the U.S. general population, with a standard deviation of 10. A higher score indicates a worse outcome. PROMIS-CAT T-scores were averaged for the control and intervention periods.'}, {'measure': 'Change in Depression Score', 'timeFrame': 'Baseline to 46 months', 'description': 'Measured PROMIS-CAT T-score up to every four months, depending on visit frequency. A T-score of 50 represents the average score for the U.S. general population, with a standard deviation of 10. A higher score indicates a worse outcome. PROMIS-CAT T-scores were averaged for the control and intervention periods.'}, {'measure': 'Change in Average Pain Interference Over the Past Week', 'timeFrame': 'Baseline to 46 months', 'description': 'Measured PROMIS-CAT T-score up to every four months, depending on visit frequency. A T-score of 50 represents the average score for the U.S. general population, with a standard deviation of 10. A higher score indicates a worse outcome. PROMIS-CAT T-scores were averaged for the control and intervention periods.'}, {'measure': 'Change in Physical Function Score', 'timeFrame': 'Baseline to 46 months', 'description': 'Measured PROMIS-CAT up to every four months, depending on visit frequency. A T-score of 50 represents the average score for the U.S. general population, with a standard deviation of 10. A higher score indicates a better outcome. PROMIS-CAT T-scores were averaged for the control and intervention periods.'}, {'measure': 'Health Care Utilization', 'timeFrame': "Up to 46 months (beginning from a participants' index medical oncology encounter until death, 18 months after last clinical encounter, or end of study)", 'description': 'ER visits, hospitalizations, and ICU admissions'}, {'measure': 'Adherence to Cancer Treatment', 'timeFrame': "Up to 46 months (beginning from a participants' index medical oncology encounter until death or end of study)", 'description': 'Number of doses of docetaxel and cyclophosphamide administered.'}, {'measure': 'Number of Deceased Participants', 'timeFrame': "Up to 46 months (beginning from a participants' index medical oncology encounter until death or end of study)", 'description': 'Vital status (living or deceased) was determined by Accurint record search across multiple sources, including the Social Security Death Index'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hematopoietic and Lymphoid Cell Neoplasm', 'Malignant Solid Neoplasm']}, 'referencesModule': {'references': [{'pmid': '32503661', 'type': 'BACKGROUND', 'citation': 'Finney Rutten LJ, Ruddy KJ, Chlan LL, Griffin JM, Herrin J, Leppin AL, Pachman DR, Ridgeway JL, Rahman PA, Storlie CB, Wilson PM, Cheville AL. Pragmatic cluster randomized trial to evaluate effectiveness and implementation of enhanced EHR-facilitated cancer symptom control (E2C2). Trials. 2020 Jun 5;21(1):480. doi: 10.1186/s13063-020-04335-w.'}, {'pmid': '41344348', 'type': 'DERIVED', 'citation': 'Cheville AL, Herrin J, Pachman DR, Grzegorczyk V, Kroenke K, Ridgeway JL, Minteer SA, Austin JD, Griffin JM, Chlan L, Tofthagen C, Mitchell SA, Smith A, Ruddy KJ. Electronic health record-facilitated symptom surveillance and collaborative care intervention in oncology (E2C2): a cluster-randomised, population-level, stepped-wedge, pragmatic trial. Lancet Oncol. 2025 Dec 1:S1470-2045(25)00526-1. doi: 10.1016/S1470-2045(25)00526-1. Online ahead of print.'}, {'pmid': '40903741', 'type': 'DERIVED', 'citation': 'Minteer SA, Ridgeway JL, Pachman DR, Austin JD, Griffin JM, Ruddy KJ, Cheville AL. Barriers and facilitators to using practice facilitators to implement a remote cancer symptom management intervention: a mixed methods study. BMC Health Serv Res. 2025 Sep 3;25(1):1189. doi: 10.1186/s12913-025-13378-1.'}, {'pmid': '40524282', 'type': 'DERIVED', 'citation': 'Kuharic M, Merle JL, Cella D, Mitchell SA, DiMartino L, Ridgeway JL, Dizon DS, Paudel R, Austin JD, Wong SL, Flores AM, Cheville AL, Smith JD; IMPACT Consortium. Psychometric evaluation of the NoMAD instrument in cancer care settings: assessing factorial validity, measurement invariance, and differential item functioning. Implement Sci Commun. 2025 Jun 16;6(1):72. doi: 10.1186/s43058-025-00756-3.'}, {'pmid': '39106420', 'type': 'DERIVED', 'citation': 'Austin JD, Finney Rutten LJ, Fischer K, Ridgeway J, Minteer S, Griffin JM, Pachman DR, Ruddy KJ, Cheville A. Advancing Care Team Adoption of Electronic Health Record Systems for Cancer Symptom Management: Findings From a Hybrid Type II, Cluster-Randomized, Stepped-Wedge Trial. JCO Oncol Pract. 2025 Feb;21(2):209-217. doi: 10.1200/OP.24.00280. Epub 2024 Aug 6.'}, {'pmid': '38380342', 'type': 'DERIVED', 'citation': 'Ridgeway JL, Cheville AL, Fischer KJ, Tesch NK, Austin JD, Minteer SA, Pachman DR, Chlan LL, Ruddy KJ, Griffin JM. Tracking activities and adaptations in a multi-site stepped wedge pragmatic trial of a cancer symptom management intervention. Contemp Clin Trials Commun. 2024 Feb 9;38:101269. doi: 10.1016/j.conctc.2024.101269. eCollection 2024 Apr.'}, {'pmid': '36738867', 'type': 'DERIVED', 'citation': 'Kroenke K, Lam V, Ruddy KJ, Pachman DR, Herrin J, Rahman PA, Griffin JM, Cheville AL. Prevalence, Severity, and Co-Occurrence of SPPADE Symptoms in 31,866 Patients With Cancer. J Pain Symptom Manage. 2023 May;65(5):367-377. doi: 10.1016/j.jpainsymman.2023.01.020. Epub 2023 Feb 2.'}]}, 'descriptionModule': {'briefSummary': 'This early phase I trial investigates enhanced, electronic health record (EHR)-facilitated cancer system control. Cancer and its treatment are often associated with severe, disabling symptoms that have been causally linked to diminished survival, increased healthcare utilization, degraded quality of life, unemployment, and non-adherence to recommended cancer treatments. Collaborative case management for control of moderate or worse sleep disturbance, pain, anxiety, depression, fatigue (SPADE symptoms), and physical dysfunction among cancer survivors and patients with cancer may improve quality of life, symptom severity, and adherence to cancer treatment, and may also reduce need for acute care.', 'detailedDescription': "PRIMARY OBJECTIVES:\n\nI. Conduct a cluster randomized pragmatic trial with a stepped wedge design to test the hypothesis that a symptom control-focused enhanced, electronic health record (EHR)-facilitated cancer symptom control (E2C2) intervention will significantly reduce sleep disturbance, pain, anxiety, depression, fatigue (SPADE) symptom and physical dysfunction scores, reduce unplanned hospitalizations and emergency department visits, improve adherence to cancer therapies, and improve self-reported quality of life.\n\nII. Evaluate the hypothesis that use of a multifaceted, evidence-based implementation strategy to support adoption and use of the E2C2 system will result in improvements in implementation and clinical outcomes.\n\nIII. Conduct a mixed methods evaluation to detect, understand and reduce disparities in the adoption and implementation of the E2C2 intervention among elderly and rural-dwelling patients with cancer.\n\nOUTLINE:\n\nThe first Primary Objective involves a stepped wedge enrollment into the study intervention. Involvement is based off the patients' responses to the pain questionnaire (low pain = no involvement, moderate pain = offer of patient education materials, severe pain = involvement of a Symptom Care Manager). Symptom Care Managers will work with interested patients who endorse high pain to help address and manage their pain. The third objective involves a subset of patients included in the E2C2 who are offered to participate in a one-time interview lasting 30-45 minutes. Providers and stakeholders also will be invited to participate in an interview lasting 15-30 minutes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being seen for a solid or liquid cancer at a Midwest Mayo Clinic Midwest Mayo Clinic Health Systems (MCHS) site or for a solid tumor at Mayo Clinic Rochester\n\nExclusion Criteria:\n\n* No Minors (under age 18) will receive the questionnaires but no further exclusions can be made based on the standard of care for questionnaire assignment'}, 'identificationModule': {'nctId': 'NCT03892967', 'briefTitle': 'Enhanced, EHR-facilitated Cancer Symptom Control Pragmatic Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Enhanced, EHR-Facilitated Cancer Symptom Control (E2C2) Trial', 'orgStudyIdInfo': {'id': '18-007779'}, 'secondaryIdInfos': [{'id': 'NCI-2020-06973', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'P30CA015083', 'link': 'https://reporter.nih.gov/quickSearch/P30CA015083', 'type': 'NIH'}, {'id': 'UM1CA233033', 'link': 'https://reporter.nih.gov/quickSearch/UM1CA233033', 'type': 'NIH'}, {'id': 'E2C2', 'type': 'OTHER', 'domain': 'Mayo Clinic Physical Medicine and Rehabilitation'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Supportive care (interview)', 'description': 'Patients randomized to E2C2 intervention participate in an interview over 30-45 minutes. Providers and stakeholders also participate in an interview over 15-30 minutes.', 'interventionNames': ['Other: Interview', 'Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration']}], 'interventions': [{'name': 'Interview', 'type': 'OTHER', 'description': 'Participate in interview', 'armGroupLabels': ['Supportive care (interview)']}, {'name': 'Quality-of-Life Assessment', 'type': 'OTHER', 'otherNames': ['Quality of Life Assessment'], 'description': 'Ancillary studies', 'armGroupLabels': ['Supportive care (interview)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Supportive care (interview)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Andrea L Cheville', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic in Rochester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}