Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-01-22 @ 6:45 AM
Study NCT ID:
NCT02728804
Status:
COMPLETED
Last Update Posted:
2023-01-26
First Post:
2016-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
S1417CD Financial Impact Assessment Tool in Patients With Metastatic Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'adarke@fredhutch.org', 'phone': '2066674623', 'title': 'Cancer Care Delivery Committee Statistician', 'organization': 'SWOG Statistics and Data Management Center'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Duration of study participant - up to 12 months.', 'description': 'Serious adverse events and other (non-serious adverse events) were not assessed for the study. All-cause mortality was assessed for the 380 participants at the start of the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Health Services Research (Questionnaire Administration)', 'description': 'Patients complete questionnaires (including the Baseline, Financial/Employment Impact, Insurance Impact, Quality of Life, and Treatment Perceptions questionnaires) over 30-60 minutes at baseline and at 3, 6, 9, and 12 months. Caregivers complete questionnaires over 30-60 minutes at baseline and at 6 and 12 months.\n\nQuality-of-Life Assessment: Complete questionnaire\n\nQuestionnaire Administration: Complete questionnaires', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 380, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 99, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cumulative Incidence Rate of Treatment-related Major Financial Hardship', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Health Services Research (Questionnaire Administration)', 'description': 'Patients complete questionnaires (including the Baseline, Financial/Employment Impact, Insurance Impact, Quality of Life, and Treatment Perceptions questionnaires) over 30-60 minutes at baseline and at 3, 6, 9, and 12 months. Caregivers complete questionnaires over 30-60 minutes at baseline and at 6 and 12 months.\n\nQuality-of-Life Assessment: Complete questionnaire\n\nQuestionnaire Administration: Complete questionnaires'}], 'classes': [{'title': 'Any MFH', 'categories': [{'measurements': [{'value': '71.3', 'groupId': 'OG000', 'lowerLimit': '65.7', 'upperLimit': '76.1'}]}]}, {'title': 'New Debt', 'categories': [{'measurements': [{'value': '57.6', 'groupId': 'OG000', 'lowerLimit': '51.7', 'upperLimit': '63.0'}]}]}, {'title': '>=20% Income Decline', 'categories': [{'measurements': [{'value': '26.6', 'groupId': 'OG000', 'lowerLimit': '21.3', 'upperLimit': '32.0'}]}]}, {'title': 'Loans from Family and/or Friends', 'categories': [{'measurements': [{'value': '26.0', 'groupId': 'OG000', 'lowerLimit': '21.5', 'upperLimit': '30.7'}]}]}, {'title': 'Refinance of Home', 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000', 'lowerLimit': '1.7', 'upperLimit': '5.9'}]}]}, {'title': 'Sale of Home', 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '4.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 12 months', 'description': 'The cumulative incidence estimates of participants experiencing both major financial hardship (MFH) and multiple financial hardships will be reported. This estimate is calculated over a 12 month period; due to participant drop out throughout this period, the calculated cumulative incidence for the participants analyzed at the 12 month mark does not equate to a whole number. A major financial hardship is defined as one or more of the following: debt accumulation of any amount, selling or refinancing home, \\>= 20% income decline, borrowing money of any amount from family/friends.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population includes only the 302 participants that were evaluable for the primary endpoint - either completed 12-month evaluation or met primary endpoint.'}, {'type': 'SECONDARY', 'title': 'Association of Age and Cumulative Incidence Rate of Major Financial Hardship', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '< 65 Years', 'description': 'This group is comprised of eligible and evaluable participants that are under 65 years of age.'}, {'id': 'OG001', 'title': '>=65 Years', 'description': 'This group is comprised of eligible and evaluable participants that are under 65 years of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '73.7', 'groupId': 'OG000', 'lowerLimit': '66.4', 'upperLimit': '79.6'}, {'value': '68.1', 'groupId': 'OG001', 'lowerLimit': '58.6', 'upperLimit': '76.0'}]}]}], 'analyses': [{'pValue': '0.65', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '0.66', 'ciUpperLimit': '1.29', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Covariate adjustment for insurance status, education, and sex.'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 12 months', 'description': 'The cumulative incidence estimates of participants experiencing MFH within age groups. This estimate is calculated over a 12 month period; due to participant drop out throughout this period, the calculated cumulative incidence for the participants analyzed at the 12 month mark does not equate to a whole number. This is used to assess whether major financial hardship at one year differs by age (\\< 65 vs. \\>= 65). Age is taken at baseline.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'There were a total of 302 participants analyzed which either completed the 12-month evaluation or met the primary endpoint.'}, {'type': 'SECONDARY', 'title': 'Association of Race and Cumulative Incidence Rate of Major Financial Hardship', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'White', 'description': 'This group is comprised of eligible and evaluable participants that identify as White.'}, {'id': 'OG001', 'title': 'Non-White', 'description': 'This group is comprised of eligible and evaluable participants that identify as a non-White race.'}], 'classes': [{'categories': [{'measurements': [{'value': '70.3', 'groupId': 'OG000', 'lowerLimit': '64.1', 'upperLimit': '75.6'}, {'value': '73.9', 'groupId': 'OG001', 'lowerLimit': '59.4', 'upperLimit': '83.9'}]}]}], 'analyses': [{'pValue': '0.70', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '0.79', 'ciUpperLimit': '1.43', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Covariate adjustment for insurance status, education, and sex.'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 12 months', 'description': 'The cumulative incidence estimates of participants experiencing MFH within racial groups. This estimate is calculated over a 12 month period; due to participant drop out throughout this period, the calculated cumulative incidence for the participants analyzed at the 12 month mark does not equate to a whole number. This is used to assess whether major financial hardship at one year differs by race (white vs. non-white).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '292 total participants were analyzed which had baseline race information available and either completed the 12-month evaluation or met the primary endpoint.'}, {'type': 'SECONDARY', 'title': 'Association of Marital Status and Cumulative Incidence Rate of Major Financial Hardship', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Not Married', 'description': 'This group is comprised of eligible and evaluable participants that are neither married nor partnered.'}, {'id': 'OG001', 'title': 'Married', 'description': 'This group is comprised of eligible and evaluable participants that are either married or partnered.'}], 'classes': [{'categories': [{'measurements': [{'value': '69.0', 'groupId': 'OG000', 'lowerLimit': '60.5', 'upperLimit': '76.1'}, {'value': '72.2', 'groupId': 'OG001', 'lowerLimit': '64.0', 'upperLimit': '78.8'}]}]}], 'analyses': [{'pValue': '0.87', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.73', 'ciUpperLimit': '1.31', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Covariate adjustment for insurance status, education, and sex.'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 12 months', 'description': 'The cumulative percentage of participants experiencing MFH within marital status groups. This is used to assess whether major financial hardship at one year differs by age (married vs. unmarried). Marital status is taken at baseline.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '295 participants were analyzed who had baseline marital status information available and either completed the 12-month evaluation or met the primary endpoint.'}, {'type': 'SECONDARY', 'title': 'Association of Employment Status and Cumulative Incidence Rate of Major Financial Hardship', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Unemployed', 'description': 'This group is comprised of eligible and evaluable participants that are unemployed.'}, {'id': 'OG001', 'title': 'Any Employment', 'description': 'This group is comprised of eligible and evaluable participants that are employed by any means. This includes full-time employment, part-time employment, self-employed, and on leave from full-time employment.'}], 'classes': [{'categories': [{'measurements': [{'value': '62.9', 'groupId': 'OG000', 'lowerLimit': '53.8', 'upperLimit': '70.7'}, {'value': '76.2', 'groupId': 'OG001', 'lowerLimit': '69.2', 'upperLimit': '81.9'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.66', 'ciLowerLimit': '0.48', 'ciUpperLimit': '0.92', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Covariate adjustment for insurance status, education, and sex.'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 12 months', 'description': 'The cumulative incidence estimates of participants experiencing MFH within different employment status groups. This estimate is calculated over a 12 month period; due to participant drop out throughout this period, the calculated cumulative incidence for the participants analyzed at the 12 month mark does not equate to a whole number. This is used to assess whether major financial hardship at one year differs by pre-diagnosis employment status (any employment vs. unemployed). Employment status is taken at baseline.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '295 participants were analyzed that had baseline employment status information available and either completed the 12-month evaluation or met the primary endpoint.'}, {'type': 'SECONDARY', 'title': 'Association of Income and Cumulative Incidence Rate of Major Financial Hardship', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '239', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '<$50,000', 'description': 'This group is comprised of eligible and evaluable participants whose yearly income is less than $50,000.'}, {'id': 'OG001', 'title': '>=$50,000', 'description': 'This group is comprised of eligible and evaluable participants whose yearly income is at least $50,000.'}, {'id': 'OG002', 'title': '<$100,000', 'description': 'This group is comprised of eligible and evaluable participants whose yearly income is less than $100,000.'}, {'id': 'OG003', 'title': '>=$100,000', 'description': 'This group is comprised of eligible and evaluable participants whose yearly income is at least $100,000.'}], 'classes': [{'categories': [{'measurements': [{'value': '72.7', 'groupId': 'OG000', 'lowerLimit': '65.6', 'upperLimit': '78.6'}, {'value': '69.1', 'groupId': 'OG001', 'lowerLimit': '59.3', 'upperLimit': '77.1'}, {'value': '72.9', 'groupId': 'OG002', 'lowerLimit': '67.0', 'upperLimit': '77.9'}, {'value': '64.9', 'groupId': 'OG003', 'lowerLimit': '45.6', 'upperLimit': '78.8'}]}]}], 'analyses': [{'pValue': '0.10', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.33', 'ciLowerLimit': '0.95', 'ciUpperLimit': '1.87', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Covariate adjustment for insurance status, education, and sex.'}, {'pValue': '0.002', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.92', 'ciLowerLimit': '1.28', 'ciUpperLimit': '2.89', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Covariate adjustment for insurance status, education, and sex.'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 12 months', 'description': 'The cumulative incidence estimates of participants experiencing MFH within income groups. This estimate is calculated over a 12 month period; due to participant drop out throughout this period, the calculated cumulative incidence for the participants analyzed at the 12 month mark does not equate to a whole number. This is used to assess whether major financial hardship at one year differs by household income (\\<$50,000 vs. \\>=$50,000 and \\<$100,000 vs. \\>=$100,000). Household income is taken at baseline.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '294 total participants were analyzed which had baseline household income information available and either completed the 12-month evaluation or met the primary endpoint. The number of participants in the \\<$50,000 arm and \\>=$50,000 arm equal the total (294) participants analyzed. Similarly, the number of participants in the \\<$100,000 arm and \\>=$100,000 arm equal the total (294) participants analyzed.'}, {'type': 'SECONDARY', 'title': 'Health-related Quality of Life (HRQOL) as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) Version 3.0', 'timeFrame': 'Up to 12 months', 'description': 'The relationship between major financial hardship and HRQOL will be assessed. Landmark analysis will be used to establish major financial hardship as a baseline predictor of HRQOL. In particular, patients will be categorized as having major financial hardship at their 3 month assessment (yes vs. no). Linear regression will then be used to assess whether the 3-month assessment of financial hardship predicts the 6-month HRQOL score. HRQOL at 3 months will be included as an adjustment covariate. The 6-month HRQOL score will be based on the EORTC QLQ-C30 questionnaire transformed into a linear sco', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Changes in Assets/Income/Wealth', 'timeFrame': 'Baseline to up to 12 months', 'description': 'Will be handled using descriptive statistics (e.g. mean, median, proportions). Descriptive statistics will be used to summarize baseline patient characteristics and will compare populations using two-sample means and proportions tests (alpha level 0.05). Caregiver strain index will be scored based on responses (score range 0 to 26). Mean scores will be compared for caregivers of patients reporting vs. not reporting at least one financial hardship.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Out-of-pocket Expenses, Defined as Total Out-of-pocket Direct Medical (e.g., Prescriptions, Physician Visits, Deductibles) and Non-medical (Transportation, Meals) Expenses in the 3 Months Prior to Each Study Visit', 'timeFrame': 'Up to 12 months', 'description': 'Will be handled using descriptive statistics (e.g. mean, median, proportions). Descriptive statistics will be used to summarize baseline patient characteristics and will compare populations using two-sample means and proportions tests (alpha level 0.05). Caregiver strain index will be scored based on responses (score range 0 to 26). Mean scores will be compared for caregivers of patients reporting vs. not reporting at least one financial hardship.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Changes in Health Insurance', 'timeFrame': 'Baseline to up to 12 months', 'description': 'Will be handled using descriptive statistics (e.g. mean, median, proportions). Descriptive statistics will be used to summarize baseline patient characteristics and will compare populations using two-sample means and proportions tests (alpha level 0.05). Caregiver strain index will be scored based on responses (score range 0 to 26). Mean scores will be compared for caregivers of patients reporting vs. not reporting at least one financial hardship.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Caregiver Participation', 'timeFrame': 'Up to 12 months', 'description': 'The caregiver component will be considered feasible if the designated caregivers for \\> 50% of eligible patients complete and submit their baseline and at least one follow-up assessment. Means, medians, and proportions will be used to describe the participating caregiver population. Analyses will be largely descriptive. If caregiver accrual is very poor (\\< 20%), describing the patient population will be the focus rather than attempting to correlate caregiver and patient responses.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Accrual to a Prospective-multi-site Longitudinal Cohort Study', 'timeFrame': 'Up to 3 years', 'description': 'Each of the NCORP components (we anticipate 25 NCORP components) will each need to enroll, on average, about 5 patients per year. Accrual will be assessed at 1.5 years after study activation. If monthly average accrual in quarters 5-6 after study registration is \\< 50% of projected accrual, efforts will be made to increase accrual over the succeeding 6 month period. If after 2 years, monthly accrual remains \\< 50% of projected accrual, study revision will be considered. In order to address the potential for selection bias, demographics (age, race, gender, etc.) of the final cohort will be compared', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Debt and Spending by Credit Report Histories', 'timeFrame': 'Up to 12 months', 'description': 'Credit histories obtained from TransUnion measure the following: non-mortgage amounts past due on credit cards and bankcards; non-mortgage credit card and bankcard balances; bankruptcies, liens, collections or repossessions. Will be handled using descriptive statistics (e.g. mean, median, proportions). Descriptive statistics will be used to summarize baseline patient characteristics and will compare populations using two-sample means and proportions tests (alpha level 0.05). Caregiver strain index will be scored based on responses (score range 0 to 26). Mean scores will be compared.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Credit History (TransUnion)', 'timeFrame': 'Up to 12 months', 'description': "The linkage of SWOG clinical and financial data with credit histories obtained from TransUnion will allow exploration of additional indicators of financial stress, including high balances and past due amounts of credit card and bankcards as well as evidence of bankruptcies, liens, and collections or repossessions in the preceding 36 months (TransUnion Inc. 'Credit Vision' report). This linked database will also provide a more complete picture of patients' pre-diagnosis financial status and post-diagnosis financial hardship. These data will also allow corroboration of self-reports.", 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Financial Stress (Patient, Caregiver, or Bereaved Caregiver)', 'timeFrame': 'Up to 12 months', 'description': 'Will be handled using descriptive statistics (e.g. mean, median, proportions). Descriptive statistics will be used to summarize baseline patient characteristics and will compare populations using two-sample means and proportions tests (alpha level 0.05). Caregiver strain index will be scored based on responses (score range 0 to 26). Mean scores will be compared for caregivers of patients reporting vs. not reporting at least one financial hardship.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Health Services Research (Questionnaire Administration)', 'description': 'Patients complete questionnaires (including the Baseline, Financial/Employment Impact, Insurance Impact, Quality of Life, and Treatment Perceptions questionnaires) over 30-60 minutes at baseline and at 3, 6, 9, and 12 months. Caregivers complete questionnaires over 30-60 minutes at baseline and at 6 and 12 months.\n\nQuality-of-Life Assessment: Complete questionnaire\n\nQuestionnaire Administration: Complete questionnaires'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '380'}]}, {'type': 'Eligible and Completed Baseline Questionnaire', 'achievements': [{'groupId': 'FG000', 'numSubjects': '368'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '269'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '111'}]}], 'dropWithdraws': [{'type': 'Ineligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Did not complete baseline questionnaire', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '99'}]}]}], 'recruitmentDetails': '380 patients were enrolled between June 2016 and January 2019.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '368', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Health Services Research (Questionnaire Administration)', 'description': 'Patients complete questionnaires (including the Baseline, Financial/Employment Impact, Insurance Impact, Quality of Life, and Treatment Perceptions questionnaires) over 30-60 minutes at baseline and at 3, 6, 9, and 12 months. Caregivers complete questionnaires over 30-60 minutes at baseline and at 6 and 12 months.\n\nQuality-of-Life Assessment: Complete questionnaire\n\nQuestionnaire Administration: Complete questionnaires'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '231', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '137', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.2', 'groupId': 'BG000', 'lowerLimit': '21.1', 'upperLimit': '89.3'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '140', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '228', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian or Pacific Islander', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '286', 'groupId': 'BG000'}]}]}, {'title': 'Other or Unknown', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Marital Status', 'classes': [{'title': 'Married/Partnered', 'categories': [{'measurements': [{'value': '213', 'groupId': 'BG000'}]}]}, {'title': 'Divorced or separated', 'categories': [{'measurements': [{'value': '82', 'groupId': 'BG000'}]}]}, {'title': 'Widowed', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}, {'title': 'Never married', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Primary Insurance', 'classes': [{'title': 'Private insurance (employer provided)', 'categories': [{'measurements': [{'value': '171', 'groupId': 'BG000'}]}]}, {'title': 'Medicare', 'categories': [{'measurements': [{'value': '143', 'groupId': 'BG000'}]}]}, {'title': 'Medicaid', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Uninsured', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Total Household Income', 'classes': [{'title': '$0-$25,000', 'categories': [{'measurements': [{'value': '114', 'groupId': 'BG000'}]}]}, {'title': '$25,001-$50,000', 'categories': [{'measurements': [{'value': '94', 'groupId': 'BG000'}]}]}, {'title': '$50,001-$75,000', 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}]}]}, {'title': '$75,001-$100,000', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}]}]}, {'title': '$100,001 or more', 'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Education', 'classes': [{'title': 'High school graduate or less', 'categories': [{'measurements': [{'value': '143', 'groupId': 'BG000'}]}]}, {'title': 'Vocational school or some college', 'categories': [{'measurements': [{'value': '111', 'groupId': 'BG000'}]}]}, {'title': 'Bachelor degree', 'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}]}]}, {'title': 'Master, doctorate, or professional degree', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Homeowner', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '236', 'groupId': 'BG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '124', 'groupId': 'BG000'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Prediagnosis Employment Status', 'classes': [{'title': 'Employed (full-time, part-time, self-employed)', 'categories': [{'measurements': [{'value': '222', 'groupId': 'BG000'}]}]}, {'title': 'Retired', 'categories': [{'measurements': [{'value': '93', 'groupId': 'BG000'}]}]}, {'title': 'On leave of absence from paid employment', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Unemployed', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}, {'title': 'Temporary or permanent disability', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}, {'title': 'Other or unknown', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Total Assets', 'classes': [{'title': '$0-$25,000', 'categories': [{'measurements': [{'value': '202', 'groupId': 'BG000'}]}]}, {'title': '$25,001-$50,000', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}, {'title': '$50,001-$100,000', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}]}]}, {'title': '$100,001-$250,000', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}]}]}, {'title': '$250,001-$500,000', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}]}]}, {'title': '$500,001 or more', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Prior Diagnosis of Stage I-III Colorectal Cancer', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '93', 'groupId': 'BG000'}]}]}, {'title': 'No, de novo diagnosis of stage IV', 'categories': [{'measurements': [{'value': '275', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'ECOG Performance Score', 'classes': [{'title': '0', 'categories': [{'measurements': [{'value': '183', 'groupId': 'BG000'}]}]}, {'title': '1', 'categories': [{'measurements': [{'value': '158', 'groupId': 'BG000'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'ECOG performance status scores range from 0 to 3, with higher scores reflecting greater disability.\n\n0: Fully active, able to carry on all pre-disease performance without restriction.\n\n1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work.\n2. Ambulatory and capable of self-care but unable to carry out any work activities; up and about more than 50% of waking hours.\n3. Capable of limited self-care, confined to bed or chair more than 50% of waking hours.', 'unitOfMeasure': 'Participants'}, {'title': 'Initial Treatment Regimen', 'classes': [{'title': '(5-FU or cap) ± bevacizumab', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}]}]}, {'title': '(FOLFOX or CapOX) ± bevacizumab', 'categories': [{'measurements': [{'value': '228', 'groupId': 'BG000'}]}]}, {'title': '(FOLFIRI or CapIRI) ± bevacizumab', 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}]}]}, {'title': '(FOLFOX, CapOX, FOLFIRI, or CapIRI) + EGFR inhibitor', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The analysis population includes the 368 participants that are eligible and completed the baseline questionnaire.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-11-21', 'size': 952718, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2022-10-04T09:16', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 380}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2020-11-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-24', 'studyFirstSubmitDate': '2016-03-30', 'resultsFirstSubmitDate': '2022-10-18', 'studyFirstSubmitQcDate': '2016-03-30', 'lastUpdatePostDateStruct': {'date': '2023-01-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-01-24', 'studyFirstPostDateStruct': {'date': '2016-04-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative Incidence Rate of Treatment-related Major Financial Hardship', 'timeFrame': 'Up to 12 months', 'description': 'The cumulative incidence estimates of participants experiencing both major financial hardship (MFH) and multiple financial hardships will be reported. This estimate is calculated over a 12 month period; due to participant drop out throughout this period, the calculated cumulative incidence for the participants analyzed at the 12 month mark does not equate to a whole number. A major financial hardship is defined as one or more of the following: debt accumulation of any amount, selling or refinancing home, \\>= 20% income decline, borrowing money of any amount from family/friends.'}], 'secondaryOutcomes': [{'measure': 'Association of Age and Cumulative Incidence Rate of Major Financial Hardship', 'timeFrame': 'Up to 12 months', 'description': 'The cumulative incidence estimates of participants experiencing MFH within age groups. This estimate is calculated over a 12 month period; due to participant drop out throughout this period, the calculated cumulative incidence for the participants analyzed at the 12 month mark does not equate to a whole number. This is used to assess whether major financial hardship at one year differs by age (\\< 65 vs. \\>= 65). Age is taken at baseline.'}, {'measure': 'Association of Race and Cumulative Incidence Rate of Major Financial Hardship', 'timeFrame': 'Up to 12 months', 'description': 'The cumulative incidence estimates of participants experiencing MFH within racial groups. This estimate is calculated over a 12 month period; due to participant drop out throughout this period, the calculated cumulative incidence for the participants analyzed at the 12 month mark does not equate to a whole number. This is used to assess whether major financial hardship at one year differs by race (white vs. non-white).'}, {'measure': 'Association of Marital Status and Cumulative Incidence Rate of Major Financial Hardship', 'timeFrame': 'Up to 12 months', 'description': 'The cumulative percentage of participants experiencing MFH within marital status groups. This is used to assess whether major financial hardship at one year differs by age (married vs. unmarried). Marital status is taken at baseline.'}, {'measure': 'Association of Employment Status and Cumulative Incidence Rate of Major Financial Hardship', 'timeFrame': 'Up to 12 months', 'description': 'The cumulative incidence estimates of participants experiencing MFH within different employment status groups. This estimate is calculated over a 12 month period; due to participant drop out throughout this period, the calculated cumulative incidence for the participants analyzed at the 12 month mark does not equate to a whole number. This is used to assess whether major financial hardship at one year differs by pre-diagnosis employment status (any employment vs. unemployed). Employment status is taken at baseline.'}, {'measure': 'Association of Income and Cumulative Incidence Rate of Major Financial Hardship', 'timeFrame': 'Up to 12 months', 'description': 'The cumulative incidence estimates of participants experiencing MFH within income groups. This estimate is calculated over a 12 month period; due to participant drop out throughout this period, the calculated cumulative incidence for the participants analyzed at the 12 month mark does not equate to a whole number. This is used to assess whether major financial hardship at one year differs by household income (\\<$50,000 vs. \\>=$50,000 and \\<$100,000 vs. \\>=$100,000). Household income is taken at baseline.'}, {'measure': 'Health-related Quality of Life (HRQOL) as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) Version 3.0', 'timeFrame': 'Up to 12 months', 'description': 'The relationship between major financial hardship and HRQOL will be assessed. Landmark analysis will be used to establish major financial hardship as a baseline predictor of HRQOL. In particular, patients will be categorized as having major financial hardship at their 3 month assessment (yes vs. no). Linear regression will then be used to assess whether the 3-month assessment of financial hardship predicts the 6-month HRQOL score. HRQOL at 3 months will be included as an adjustment covariate. The 6-month HRQOL score will be based on the EORTC QLQ-C30 questionnaire transformed into a linear sco'}, {'measure': 'Changes in Assets/Income/Wealth', 'timeFrame': 'Baseline to up to 12 months', 'description': 'Will be handled using descriptive statistics (e.g. mean, median, proportions). Descriptive statistics will be used to summarize baseline patient characteristics and will compare populations using two-sample means and proportions tests (alpha level 0.05). Caregiver strain index will be scored based on responses (score range 0 to 26). Mean scores will be compared for caregivers of patients reporting vs. not reporting at least one financial hardship.'}, {'measure': 'Out-of-pocket Expenses, Defined as Total Out-of-pocket Direct Medical (e.g., Prescriptions, Physician Visits, Deductibles) and Non-medical (Transportation, Meals) Expenses in the 3 Months Prior to Each Study Visit', 'timeFrame': 'Up to 12 months', 'description': 'Will be handled using descriptive statistics (e.g. mean, median, proportions). Descriptive statistics will be used to summarize baseline patient characteristics and will compare populations using two-sample means and proportions tests (alpha level 0.05). Caregiver strain index will be scored based on responses (score range 0 to 26). Mean scores will be compared for caregivers of patients reporting vs. not reporting at least one financial hardship.'}, {'measure': 'Changes in Health Insurance', 'timeFrame': 'Baseline to up to 12 months', 'description': 'Will be handled using descriptive statistics (e.g. mean, median, proportions). Descriptive statistics will be used to summarize baseline patient characteristics and will compare populations using two-sample means and proportions tests (alpha level 0.05). Caregiver strain index will be scored based on responses (score range 0 to 26). Mean scores will be compared for caregivers of patients reporting vs. not reporting at least one financial hardship.'}, {'measure': 'Caregiver Participation', 'timeFrame': 'Up to 12 months', 'description': 'The caregiver component will be considered feasible if the designated caregivers for \\> 50% of eligible patients complete and submit their baseline and at least one follow-up assessment. Means, medians, and proportions will be used to describe the participating caregiver population. Analyses will be largely descriptive. If caregiver accrual is very poor (\\< 20%), describing the patient population will be the focus rather than attempting to correlate caregiver and patient responses.'}, {'measure': 'Accrual to a Prospective-multi-site Longitudinal Cohort Study', 'timeFrame': 'Up to 3 years', 'description': 'Each of the NCORP components (we anticipate 25 NCORP components) will each need to enroll, on average, about 5 patients per year. Accrual will be assessed at 1.5 years after study activation. If monthly average accrual in quarters 5-6 after study registration is \\< 50% of projected accrual, efforts will be made to increase accrual over the succeeding 6 month period. If after 2 years, monthly accrual remains \\< 50% of projected accrual, study revision will be considered. In order to address the potential for selection bias, demographics (age, race, gender, etc.) of the final cohort will be compared'}, {'measure': 'Debt and Spending by Credit Report Histories', 'timeFrame': 'Up to 12 months', 'description': 'Credit histories obtained from TransUnion measure the following: non-mortgage amounts past due on credit cards and bankcards; non-mortgage credit card and bankcard balances; bankruptcies, liens, collections or repossessions. Will be handled using descriptive statistics (e.g. mean, median, proportions). Descriptive statistics will be used to summarize baseline patient characteristics and will compare populations using two-sample means and proportions tests (alpha level 0.05). Caregiver strain index will be scored based on responses (score range 0 to 26). Mean scores will be compared.'}, {'measure': 'Credit History (TransUnion)', 'timeFrame': 'Up to 12 months', 'description': "The linkage of SWOG clinical and financial data with credit histories obtained from TransUnion will allow exploration of additional indicators of financial stress, including high balances and past due amounts of credit card and bankcards as well as evidence of bankruptcies, liens, and collections or repossessions in the preceding 36 months (TransUnion Inc. 'Credit Vision' report). This linked database will also provide a more complete picture of patients' pre-diagnosis financial status and post-diagnosis financial hardship. These data will also allow corroboration of self-reports."}, {'measure': 'Financial Stress (Patient, Caregiver, or Bereaved Caregiver)', 'timeFrame': 'Up to 12 months', 'description': 'Will be handled using descriptive statistics (e.g. mean, median, proportions). Descriptive statistics will be used to summarize baseline patient characteristics and will compare populations using two-sample means and proportions tests (alpha level 0.05). Caregiver strain index will be scored based on responses (score range 0 to 26). Mean scores will be compared for caregivers of patients reporting vs. not reporting at least one financial hardship.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Stage IVA Colon Cancer', 'Stage IVA Rectal Cancer', 'Stage IVB Colon Cancer', 'Stage IVB Rectal Cancer']}, 'descriptionModule': {'briefSummary': 'This clinical trial studies the use of the financial impact assessment tool in patients with colorectal cancer that has spread from the primary site to other places in the body. Gathering information about patients with colorectal cancer over time may help doctors better understand the financial impact of cancer and help patients avoid financial problems during treatment.', 'detailedDescription': "PRIMARY OBJECTIVES:\n\nI. To estimate the incidence of treatment-related major financial hardship over 12 months, among patients with newly diagnosed metastatic colorectal cancer (mCRC) treated at components and subcomponents of the National Cancer Institute (NCI) Community Oncology Research Program (NCORP).\n\nSECONDARY OBJECTIVES:\n\nI. To describe the association of major financial hardships with mCRC treatment by demographic factors, including age, race, marital status, employment status, and income.\n\nII. To explore whether occurrence of major financial hardship is associated with poorer health-related quality of life over time.\n\nIII. To profile the magnitude and timing of treatment-related changes in patients' income, assets, debt, and employment, and to quantify major out-of-pocket expenses during the 12 months following registration.\n\nIV. To explore the extent to which health insurance factors (e.g. high copayments, deductibles, premiums, loss/change of insurance plan) are associated with major financial hardship and treatment non-adherence.\n\nV. To determine feasibility of recruiting primary caregivers and measuring caregiver burden and caregivers' perceptions about cancer treatment costs.\n\nVI. To determine the feasibility of conducting a prospective-multi-site longitudinal cohort study assessing financial outcomes in patients with mCRC undergoing treatment within the NCORP network.\n\nTERTIARY OBJECTIVES:\n\nI. To obtain objective measures of expenses, debt and credit through linkage with individual patient credit reports (TransUnion) at enrollment (baseline) and end of follow up (12 months).\n\nOUTLINE:\n\nPatients complete questionnaires (including the Baseline, Financial/Employment Impact, Insurance Impact, Quality of Life, and Treatment Perceptions questionnaires) over 30-60 minutes at baseline and at 3, 6, 9, and 12 months. Caregivers complete questionnaires over 30-60 minutes at baseline and at 6 and 12 months."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with newly diagnosed metastatic colon or rectal cancer treated at NCORP sites.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients must have newly diagnosed metastatic colon or rectal cancer (mCRC) (de novo metastatic diagnosis) or metastatic recurrence after prior treatment for stage I-III disease and be \\</= 120 days after diagnosis at time of registration\n* Systemic chemotherapy and/or systemic biologic therapy must be planned to be administered within 30 days after registration or must have been initiated within 60 days prior to registration; patients who are planning palliative or hospice care only (no chemotherapy or biologic therapy) are not eligible\n* Registering site must be an NCORP site; it is recommended that patients receive care for the mCRC at the registering site to ensure accessibility of patient records.\n* Patients must be able to complete questionnaires in English\n* Patients must provide their full name, primary address in the United States (U.S.), birth date and social security number at registration for the purposes of accessing credit report data\n* Patients must sign and give written informed consent in accordance with institutional and federal guidelines\n* As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system"}, 'identificationModule': {'nctId': 'NCT02728804', 'briefTitle': 'S1417CD Financial Impact Assessment Tool in Patients With Metastatic Colorectal Cancer', 'nctIdAliases': ['NCT02755571'], 'organization': {'class': 'NETWORK', 'fullName': 'SWOG Cancer Research Network'}, 'officialTitle': 'Implementation of a Prospective Financial Impact Assessment Tool in Patients With Metastatic Colorectal Cancer', 'orgStudyIdInfo': {'id': 'S1417CD'}, 'secondaryIdInfos': [{'id': 'NCI-2015-01885', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'S1417'}, {'id': 'S1417CD', 'type': 'OTHER', 'domain': 'SWOG'}, {'id': 'SWOG-S1417CD', 'type': 'OTHER', 'domain': 'DCP'}, {'id': 'S1417CD', 'type': 'OTHER', 'domain': 'CTEP'}, {'id': 'UG1CA189974', 'link': 'https://reporter.nih.gov/quickSearch/UG1CA189974', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Health Services Research (questionnaire administration)', 'description': 'Patients complete questionnaires (including the Baseline, Financial/Employment Impact, Insurance Impact, Quality of Life, and Treatment Perceptions questionnaires) over 30-60 minutes at baseline and at 3, 6, 9, and 12 months. Caregivers complete questionnaires over 30-60 minutes at baseline and at 6 and 12 months.', 'interventionNames': ['Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration']}], 'interventions': [{'name': 'Quality-of-Life Assessment', 'type': 'OTHER', 'otherNames': ['Quality of Life Assessment'], 'description': 'Complete questionnaire', 'armGroupLabels': ['Health Services Research (questionnaire administration)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Complete questionnaires', 'armGroupLabels': ['Health Services Research (questionnaire administration)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Anchorage Associates in Radiation Medicine', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Alaska Breast Care and Surgery LLC', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Alaska Oncology and Hematology LLC', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': "Alaska Women's Cancer Care", 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Katmai Oncology Group', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Providence Alaska Medical Center', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '71913', 'city': 'Hot Springs', 'state': 'Arkansas', 'country': 'United States', 'facility': 'CHI Saint Vincent Cancer Center Hot Springs', 'geoPoint': {'lat': 34.5037, 'lon': -93.05518}}, {'zip': '94531', 'city': 'Antioch', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente-Deer Valley Medical Center', 'geoPoint': {'lat': 38.00492, 'lon': -121.80579}}, {'zip': '91505', 'city': 'Burbank', 'state': 'California', 'country': 'United States', 'facility': 'Providence Saint Joseph Medical Center/Disney Family Cancer Center', 'geoPoint': {'lat': 34.18084, 'lon': -118.30897}}, {'zip': '94568', 'city': 'Dublin', 'state': 'California', 'country': 'United States', 'facility': 'Epic Care-Dublin', 'geoPoint': {'lat': 37.70215, 'lon': -121.93579}}, {'zip': '94608', 'city': 'Emeryville', 'state': 'California', 'country': 'United States', 'facility': 'Bay Area Breast Surgeons Inc', 'geoPoint': {'lat': 37.83132, 'lon': -122.28525}}, {'zip': '94608', 'city': 'Emeryville', 'state': 'California', 'country': 'United States', 'facility': 'Epic Care Partners in Cancer Care', 'geoPoint': {'lat': 37.83132, 'lon': -122.28525}}, {'zip': '94538', 'city': 'Fremont', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente-Fremont', 'geoPoint': {'lat': 37.54827, 'lon': -121.98857}}, {'zip': '93720', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente-Fresno', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '94553-3156', 'city': 'Martinez', 'state': 'California', 'country': 'United States', 'facility': 'Contra Costa Regional Medical Center', 'geoPoint': {'lat': 38.01937, 'lon': -122.13413}}, {'zip': '95356', 'city': 'Modesto', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente-Modesto', 'geoPoint': {'lat': 37.6391, 'lon': -120.99688}}, {'zip': '94609', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'Alta Bates Summit Medical Center - Summit Campus', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '94609', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'Bay Area Tumor Institute', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '94611', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente-Oakland', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '94063', 'city': 'Redwood City', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente-Redwood City', 'geoPoint': {'lat': 37.48522, 'lon': -122.23635}}, {'zip': '94801', 'city': 'Richmond', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente-Richmond', 'geoPoint': {'lat': 37.93576, 'lon': -122.34775}}, {'zip': '95661', 'city': 'Roseville', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente-Roseville', 'geoPoint': {'lat': 38.75212, 'lon': -121.28801}}, {'zip': '95823', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente-South Sacramento', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '95825', 'city': 'Sacramento', 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