Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2026-01-03 @ 8:39 PM
Study NCT ID:
NCT03860961
Status:
COMPLETED
Last Update Posted:
2025-11-03
First Post:
2019-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Increasing the Dose of Survivorship Care Planning in Improving Care and Outcomes in Prostate Cancer Survivors Receiving Androgen Deprivation Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'seiferheldw@nrgoncology.org', 'phone': '(215) 574-3208', 'title': 'Wendy Seiferheld', 'organization': 'NRG Oncology'}, 'certainAgreement': {'otherDetails': "PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.', 'description': 'All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm A (SCP)', 'description': 'Practices review a SCP with patients and send it to the PCP during the last week of RT.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Arm B (Enhanced SCP)', 'description': 'Practices review a treatment plan (TP) with patients and send it to the PCP at the beginning of RT. Practices also review a SCP as in arm A.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients Adhering to Cardiovascular Follow-up Recommendations in the Second Year After Radiation Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (Survivorship Care Plan)', 'description': 'Practices review a SCP with patients and send it to the PCP during the last week of RT.'}, {'id': 'OG001', 'title': 'Arm B (Enhanced Survivorship Care Plan)', 'description': 'Practices review a treatment plan (TP) with patients and send it to the PCP at the beginning of RT. Practices also review a SCP as in arm A.'}], 'classes': [{'categories': [{'measurements': [{'value': '160', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9238', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Two-sided significance level = 0.05', 'groupDescription': 'Cluster-randomized trial, cluster=practice, maximum 25 patients/practice. Assuming 14 pts/practice, cluster size coefficient of variation of 0.5, intra-cluster correlation (ρ) of 0.04, design effect 1.51, and 59.8% of Arm A patients meeting the criteria provides 80% power for a two-sided α=0.05 two-sample test of proportions to detect a 15% absolute improvement in percentage of patients meeting the criteria with 544 patients (after adjusted for withdrawal and loss to follow-up).', 'statisticalMethod': 'Chi-squared, Corrected', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the second year (13 to 24 months) after completion of approximately 4-9 weeks of radiation therapy.', 'description': "A joint publication from the American Heart Association, American Cancer Society and American Urological Association made specific recommendations regarding cardiovascular follow-up for prostate cancer patients who receive androgen deprivation therapy (ADT) (Levine, 2010). Medical records from each participant's primary care physician (PCP) and cardiologist were reviewed to determine if a participant received care that followed the guideline recommendations interpreted in this study as meeting all three of the following criteria:\n\n* saw a primary care provider (PCP) or cardiologist\n* had fasting blood glucose checked\n* had fasting cholesterol check.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible participants from randomized practices with necessary data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Calculated Cardiovascular (CVD) Risk Score at Two Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (Survivorship Care Plan)', 'description': 'Practices review a Survivorship Care Plan (SCP) with patients and send it to the primary care physician (PCP) during the last week of radiation therapy (RT).'}, {'id': 'OG001', 'title': 'Arm B (Enhanced Survivorship Care Plan)', 'description': 'Practices review a treatment plan (TP) with patients and send it to the PCP at the beginning of RT. Practices also review a SCP as in arm A.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.257', 'spread': '0.134', 'groupId': 'OG000'}, {'value': '0.256', 'spread': '0.135', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5609', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Two-sided significance level = 0.05', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Model included baseline CVD risk score, practice as random covariate (participants nested within practice) and treatment arm.'}], 'paramType': 'MEAN', 'timeFrame': 'Two years after completion of approximately 4-9 weeks of radiation therapy.', 'description': 'CVD risk score is obtained using the American Heart Association Risk Calculator (Goff et al, 2013). The calculator requires sex (all participants are male in this trial), age, race (White, African American, Other), HDL, total cholesterol, systolic blood pressure, diabetes (yes/no), treatment for hypertension (yes/no), smoker (yes/no), and provides a 10-year risk of atherosclerotic cardiovascular disease (ASCVD) events ranging from 0 (low risk) to 1 (high risk). The calculator documentation states that risk may be overestimated or underestimated for some subgroups of the race category "Other", therefore score is not calculated for any participants in this category.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible participants with CVD risk score at two years.'}, {'type': 'SECONDARY', 'title': 'Components of the Primary Care Index (CPCI) Coordination of Care Subscale Score With Respect to the PCP (or Cardiologist if Patient Does Not Have a PCP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (Survivorship Care Plan)', 'description': 'Practices review a Survivorship Care Plan (SCP) with patients and send it to the primary care physician (PCP) during the last week of radiation therapy (RT).'}, {'id': 'OG001', 'title': 'Arm B (Enhanced Survivorship Care Plan)', 'description': 'Practices review a treatment plan (TP) with patients and send it to the PCP at the beginning of RT. Practices also review a SCP as in arm A.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.29', 'spread': '0.96', 'groupId': 'OG000'}, {'value': '5.46', 'spread': '0.97', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Two years after completion of approximately 4-9 weeks of radiation therapy.', 'description': "The Components of the Primary Care Index is a validated instrument specifically designed to measure aspects of primary care delivery from the patient's perspective. The coordination of care subscale measures the patients' perception of their physician's knowledge of other visits and visits to specialists, as well as the physician's follow-up of problems. Patients respond to six items, each on a 6-point Likert scale: strongly disagree (1), to strongly agree (6). The subscale score is the mean of the 6 items, with negatively-worded questions scored in reverse. A higher score indicates better coordination of care. All items had to be completed in order to calculate the score.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible participants with two-year CPCI data'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction With Care With Respect to the PCP (or Cardiologist if Patient Does Not Have a PCP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (Survivorship Care Plan)', 'description': 'Practices review a Survivorship Care Plan (SCP) with patients and send it to the primary care physician (PCP) during the last week of radiation therapy (RT).'}, {'id': 'OG001', 'title': 'Arm B (Enhanced Survivorship Care Plan)', 'description': 'Practices review a treatment plan (TP) with patients and send it to the PCP at the beginning of RT. Practices also review a SCP as in arm A.'}], 'classes': [{'categories': [{'measurements': [{'value': '81.96', 'spread': '9.18', 'groupId': 'OG000'}, {'value': '82.68', 'spread': '11.80', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Two years after completion of approximately 4-9 weeks of radiation therapy.', 'description': 'This 18-item instrument evaluates patient-reported outcomes related to satisfaction with cancer-related care. Patients respond to each item on a 5-point Likert scale from strongly disagree (1) to strongly agree (5). A total scale score is calculated by adding scores on all 18 items, ranging from 18 to 90. A higher score indicates higher satisfaction. All items had to be completed in order to calculate the score.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible participants with two-year Patient Satisfaction with Care questionnaire data.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Components of the Primary Care Index (CPCI) Coordination of Care Subscale Score With Respect to the Cancer Specialist', 'timeFrame': 'Two years after completion of approximately 4-9 weeks of radiation therapy.', 'description': "The Components of the Primary Care Index is a validated instrument specifically designed to measure aspects of primary care delivery from the patient's perspective. The coordination of care subscale measures the patients' perception of their physician's knowledge of other visits and visits to specialists, as well as the physician's follow-up of problems. Patients respond to six items, each on a 6-point Likert scale: strongly disagree (1), to strongly agree (6). The subscale score is the mean of the 6 items, with negatively-worded questions scored in reverse. A higher score indicates better coordination of care. All items had to be completed in order to calculate the score.", 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Patient Satisfaction With Care With Respect to the Cancer Specialist', 'timeFrame': 'Two years after completion of approximately 4-9 weeks of radiation therapy.', 'description': 'This 18-item instrument evaluates patient-reported outcomes related to satisfaction with cancer-related care. Patients respond to each item on a 5-point Likert scale from strongly disagree (1) to strongly agree (5). A total scale score is calculated by adding scores on all 18 items, ranging from 18 to 90. A higher score indicates higher satisfaction. All items had to be completed in order to calculate the score.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm A (Survivorship Care Plan)', 'description': 'Practices review a Survivorship Care Plan (SCP) with patients and send it to the primary care physician (PCP) during the last week of radiation therapy (RT).'}, {'id': 'FG001', 'title': 'Arm B (Enhanced Survivorship Care Plan)', 'description': 'Practices review a treatment plan (TP) with patients and send it to the PCP at the beginning of RT. Practices also review a SCP as in arm A.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '18', 'numSubjects': '277'}, {'groupId': 'FG001', 'numUnits': '17', 'numSubjects': '273'}]}, {'type': 'COMPLETED', 'comment': 'Number of participants evaluable for the primary endpoint', 'achievements': [{'groupId': 'FG000', 'numUnits': '18', 'numSubjects': '257'}, {'groupId': 'FG001', 'numUnits': '17', 'numSubjects': '256'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '20'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '17'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Incomplete two-year data', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'Practices', 'preAssignmentDetails': 'Of 833 participants screened at randomized practices, 550 were enrolled.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '550', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm A (SCP)', 'description': 'Practices review a SCP with patients and send it to the PCP during the last week of RT.'}, {'id': 'BG001', 'title': 'Arm B (Enhanced SCP)', 'description': 'Practices review a treatment plan (TP) with patients and send it to the PCP at the beginning of RT. Practices also review a SCP as in arm A.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '550', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000', 'lowerLimit': '49', 'upperLimit': '88'}, {'value': '70', 'groupId': 'BG001', 'lowerLimit': '53', 'upperLimit': '91'}, {'value': '70', 'groupId': 'BG002', 'lowerLimit': '49', 'upperLimit': '91'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Age, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '550', 'groupId': 'BG002'}]}], 'categories': [{'title': '< 65 years', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}]}, {'title': '≥ 65 years', 'measurements': [{'value': '207', 'groupId': 'BG000'}, {'value': '212', 'groupId': 'BG001'}, {'value': '419', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '550', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '277', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '550', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '550', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '268', 'groupId': 'BG000'}, {'value': '261', 'groupId': 'BG001'}, {'value': '529', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '550', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '229', 'groupId': 'BG000'}, {'value': '220', 'groupId': 'BG001'}, {'value': '449', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Past smoker', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '550', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '142', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '281', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Current smoker', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '550', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Uses hypertension medication', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '550', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '187', 'groupId': 'BG000'}, {'value': '179', 'groupId': 'BG001'}, {'value': '366', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Has Diabetes', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '550', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of comorbidities determined by the Adult Comorbitity Evaluation-27 (ACE-27)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '550', 'groupId': 'BG002'}]}], 'categories': [{'title': '≤ 2', 'measurements': [{'value': '185', 'groupId': 'BG000'}, {'value': '181', 'groupId': 'BG001'}, {'value': '366', 'groupId': 'BG002'}]}, {'title': '>2', 'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '184', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The Adult Comorbidity Evaluation-27 (ACE-27) is a tool used to assess comorbid conditions in adult patients, particularly in the context of cancer care. For this study it is utilized here only to determine the number of comorbid conditions rather to than to calculate a score based on both the presence and severity of such conditions.', 'unitOfMeasure': 'Participants'}, {'title': 'Health Literacy Level determined by Brief Health Literacy Screen (BHLS)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'BG000'}, {'value': '271', 'groupId': 'BG001'}, {'value': '547', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Inadequate', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}, {'title': 'Marginal', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}, {'title': 'Adequate', 'measurements': [{'value': '201', 'groupId': 'BG000'}, {'value': '175', 'groupId': 'BG001'}, {'value': '376', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'BHLS is a validated instrument that consists of three questions on a 5-point response scale. The total score ranges from 3 to 15, by which participants are then categorized as having inadequate, marginal, or adequate health literacy.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Due to incomplete questionnaires, the BHLS score was not able to be calculated for all participants.'}], 'populationDescription': 'Enrolled participants'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-03-24', 'size': 540706, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-08-26T12:59', 'hasProtocol': True}, {'date': '2021-03-24', 'size': 243274, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-08-26T13:02', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 550}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-09-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-08', 'studyFirstSubmitDate': '2019-02-26', 'resultsFirstSubmitDate': '2025-09-09', 'studyFirstSubmitQcDate': '2019-02-28', 'lastUpdatePostDateStruct': {'date': '2025-11-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-10-08', 'studyFirstPostDateStruct': {'date': '2019-03-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-11-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-11-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Components of the Primary Care Index (CPCI) Coordination of Care Subscale Score With Respect to the Cancer Specialist', 'timeFrame': 'Two years after completion of approximately 4-9 weeks of radiation therapy.', 'description': "The Components of the Primary Care Index is a validated instrument specifically designed to measure aspects of primary care delivery from the patient's perspective. The coordination of care subscale measures the patients' perception of their physician's knowledge of other visits and visits to specialists, as well as the physician's follow-up of problems. Patients respond to six items, each on a 6-point Likert scale: strongly disagree (1), to strongly agree (6). The subscale score is the mean of the 6 items, with negatively-worded questions scored in reverse. A higher score indicates better coordination of care. All items had to be completed in order to calculate the score."}, {'measure': 'Patient Satisfaction With Care With Respect to the Cancer Specialist', 'timeFrame': 'Two years after completion of approximately 4-9 weeks of radiation therapy.', 'description': 'This 18-item instrument evaluates patient-reported outcomes related to satisfaction with cancer-related care. Patients respond to each item on a 5-point Likert scale from strongly disagree (1) to strongly agree (5). A total scale score is calculated by adding scores on all 18 items, ranging from 18 to 90. A higher score indicates higher satisfaction. All items had to be completed in order to calculate the score.'}], 'primaryOutcomes': [{'measure': 'Number of Patients Adhering to Cardiovascular Follow-up Recommendations in the Second Year After Radiation Treatment', 'timeFrame': 'During the second year (13 to 24 months) after completion of approximately 4-9 weeks of radiation therapy.', 'description': "A joint publication from the American Heart Association, American Cancer Society and American Urological Association made specific recommendations regarding cardiovascular follow-up for prostate cancer patients who receive androgen deprivation therapy (ADT) (Levine, 2010). Medical records from each participant's primary care physician (PCP) and cardiologist were reviewed to determine if a participant received care that followed the guideline recommendations interpreted in this study as meeting all three of the following criteria:\n\n* saw a primary care provider (PCP) or cardiologist\n* had fasting blood glucose checked\n* had fasting cholesterol check."}], 'secondaryOutcomes': [{'measure': 'Calculated Cardiovascular (CVD) Risk Score at Two Years', 'timeFrame': 'Two years after completion of approximately 4-9 weeks of radiation therapy.', 'description': 'CVD risk score is obtained using the American Heart Association Risk Calculator (Goff et al, 2013). The calculator requires sex (all participants are male in this trial), age, race (White, African American, Other), HDL, total cholesterol, systolic blood pressure, diabetes (yes/no), treatment for hypertension (yes/no), smoker (yes/no), and provides a 10-year risk of atherosclerotic cardiovascular disease (ASCVD) events ranging from 0 (low risk) to 1 (high risk). The calculator documentation states that risk may be overestimated or underestimated for some subgroups of the race category "Other", therefore score is not calculated for any participants in this category.'}, {'measure': 'Components of the Primary Care Index (CPCI) Coordination of Care Subscale Score With Respect to the PCP (or Cardiologist if Patient Does Not Have a PCP)', 'timeFrame': 'Two years after completion of approximately 4-9 weeks of radiation therapy.', 'description': "The Components of the Primary Care Index is a validated instrument specifically designed to measure aspects of primary care delivery from the patient's perspective. The coordination of care subscale measures the patients' perception of their physician's knowledge of other visits and visits to specialists, as well as the physician's follow-up of problems. Patients respond to six items, each on a 6-point Likert scale: strongly disagree (1), to strongly agree (6). The subscale score is the mean of the 6 items, with negatively-worded questions scored in reverse. A higher score indicates better coordination of care. All items had to be completed in order to calculate the score."}, {'measure': 'Patient Satisfaction With Care With Respect to the PCP (or Cardiologist if Patient Does Not Have a PCP)', 'timeFrame': 'Two years after completion of approximately 4-9 weeks of radiation therapy.', 'description': 'This 18-item instrument evaluates patient-reported outcomes related to satisfaction with cancer-related care. Patients respond to each item on a 5-point Likert scale from strongly disagree (1) to strongly agree (5). A total scale score is calculated by adding scores on all 18 items, ranging from 18 to 90. A higher score indicates higher satisfaction. All items had to be completed in order to calculate the score.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Adenocarcinoma']}, 'descriptionModule': {'briefSummary': "This trial studies how well increasing the dose of survivorship care planning improves care and outcomes in prostate cancer survivors receiving radiation therapy and androgen deprivation therapy. There is a need for coordinated care between the cancer care team with the primary care team. This is especially important for prostate cancer survivors who need routine cancer care follow-up with their radiation oncologist and also coordinated routine follow-up with their primary care provider (PCP). This is important because androgen deprivation therapy increases a patient's risk for developing diabetes, hypercholesterolemia, and cardiovascular events. Increasing the dose of survivorship may improve care and outcomes of cancer survivors than standard practices.", 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To determine if the experimental arm (increased doses of survivorship care planning \\[SCP\\]) has more patients who saw a primary care provider and had blood glucose and cholesterol checked in year 2 (13-24 months) after finishing radiation therapy (RT) as compared to the control arm.\n\nSECONDARY OBJECTIVES:\n\nI. To determine if patients who receive increased doses of SCP have lower cardiovascular disease (CVD) risk score at 2 years as compared to patients who receive a one-time SCP.\n\nII. To determine if patients who receive increased doses of SCP have improved patient reported coordination and satisfaction with care with respect to their primary care provider (PCP) or cardiologist as compared to patients who receive a one-time SCP and whether health literacy modifies the effect of SCP use on patient-reported coordination of care and satisfaction with care with respect to their PCP or cardiologist.\n\nIII. To determine the number of patients eligible, but without a PCP/cardiologist.\n\nIV. To describe the current practice related to SCP delivery and prostate cancer survivor monitoring in participating National Cancer Institute (NCI) Community Oncology Research Program (NCORP) practices.\n\nEXPLORATORY OBJECTIVE:\n\nI. To determine if patients who receive increased doses of SCP have improved patient reported coordination and satisfaction with care with respect to their cancer specialist as compared to patients who receive a one-time SCP and whether health literacy modifies the effect of SCP use on patient-reported coordination of care and satisfaction with care with respect to their cancer specialist.\n\nPractices are randomized to 1 of 2 arms. After completion of study, patients are followed up periodically.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PRACTICE ELIGIBILITY CRITERIA\n* All institutions participating in a practice are NCORP components or sub-components\n* Have a mechanism for delivering SCPs to prostate cancer patients. Practices that currently provide SCPs are eligible but for this trial will need to use the study-provided SCP template.\n* See at least 10 patients meeting eligibility criteria per year.\n* Completion and submission of the NRG-CC007CD Letter of Intent (LOI) (posted on the Cancer Trials Support Unit \\[CTSU\\] website) by each practice to NRGCC007CD@nrgoncology.org).\n* Institutional Review Board (IRB) approval\n* Each principal investigator (PI) and research assistant (RA) at a NCORP practice must complete NRG-CC007CD SCP training. A training certificate will need to be completed and uploaded to the CTSU Regulatory Submission Portal. (See NRG-CC007CD Training Memo and Slides; located on the CTSU website). Note: staff and physicians cannot be part of multiple practices\n* For a practice that is participating on Wake Forest study, WF-1804CD is not able to participate in this trial in order to not impact the fidelity of either trial. As long as the clinicians (physicians, American Physician Partners \\[APPs\\]) are different for the patient populations of the two trials, a practice is eligible to participate in both trials\n* PATIENT ELIGIBILITY CRITERIA - PRIOR TO REGISTRATION (STEP 1)\n* The participant must be able to complete required questionnaires in English\n* The participant must have a diagnosis of prostate adenocarcinoma that will be treated with RT plus androgen deprivation therapy (ADT) with curative intent. Both definitive RT (intact prostate) and postprostatectomy RT patients are eligible\n\n * The ADT must be planned for at least 4 months and must include luteinizing hormone-releasing hormone (LHRH) agonist or LHRH antagonist\n * ADT may have started for no more than 120 days before registration\n* The participant must have a primary care provider and/or cardiologist or plan to obtain one\n* Comorbidities assessed at study entry using the Adult Comorbidity Evaluation (ACE)-27 instrument (located on the CTSU website)\n* The patient or a legally authorized representative must provide study-specific informed consent prior to study entry'}, 'identificationModule': {'nctId': 'NCT03860961', 'briefTitle': 'Increasing the Dose of Survivorship Care Planning in Improving Care and Outcomes in Prostate Cancer Survivors Receiving Androgen Deprivation Therapy', 'organization': {'class': 'OTHER', 'fullName': 'NRG Oncology'}, 'officialTitle': 'Increasing the Dose of Survivorship Care Planning in Prostate Cancer Survivors Who Receive Androgen Deprivation Therapy', 'orgStudyIdInfo': {'id': 'NRG-CC007CD'}, 'secondaryIdInfos': [{'id': 'NCI-2019-00794', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'NRG-CC007CD', 'type': 'OTHER', 'domain': 'NRG Oncology'}, {'id': 'NRG-CC007CD', 'type': 'OTHER', 'domain': 'DCP'}, {'id': 'NRG-CC007CD', 'type': 'OTHER', 'domain': 'CTEP'}, {'id': 'UG1CA189867', 'link': 'https://reporter.nih.gov/quickSearch/UG1CA189867', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm A (Survivorship Care Plan)', 'description': 'Practices review a Survivorship Care Plan (SCP) with patients and send it to the primary care physician (PCP) during the last week of radiation therapy (RT).', 'interventionNames': ['Other: Survivorship Care Plan']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B (Enhanced Survivorship Care Plan)', 'description': 'Practices review a treatment plan (TP) with patients and send it to the PCP at the beginning of RT. Practices also review a SCP as in arm A.', 'interventionNames': ['Other: Survivorship Care Plan', 'Other: Treatment Plan']}], 'interventions': [{'name': 'Survivorship Care Plan', 'type': 'OTHER', 'description': 'Given survivorship care plan', 'armGroupLabels': ['Arm A (Survivorship Care Plan)', 'Arm B (Enhanced Survivorship Care Plan)']}, {'name': 'Treatment Plan', 'type': 'OTHER', 'description': 'Given treatment plan', 'armGroupLabels': ['Arm B (Enhanced Survivorship Care Plan)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '86401', 'city': 'Kingman', 'state': 'Arizona', 'country': 'United States', 'facility': 'Kingman Regional Medical Center', 'geoPoint': {'lat': 35.18944, 'lon': -114.05301}}, {'zip': '94568', 'city': 'Dublin', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Dublin', 'geoPoint': {'lat': 37.70215, 'lon': -121.93579}}, {'zip': '94611', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Oakland-Broadway', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '95670', 'city': 'Rancho Cordova', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente-Rancho Cordova Cancer Center', 'geoPoint': {'lat': 38.58907, 'lon': -121.30273}}, {'zip': '94928', 'city': 'Rohnert Park', 'state': 'California', 'country': 'United States', 'facility': 'Rohnert Park Cancer Center', 'geoPoint': {'lat': 38.33964, 'lon': -122.7011}}, {'zip': '95678', 'city': 'Roseville', 'state': 'California', 'country': 'United States', 'facility': 'The Permanente Medical Group-Roseville Radiation Oncology', 'geoPoint': {'lat': 38.75212, 'lon': -121.28801}}, {'zip': '95051', 'city': 'Santa Clara', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Medical Center - Santa Clara', 'geoPoint': {'lat': 37.35411, 'lon': -121.95524}}, {'zip': '94080', 'city': 'South San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Cancer Treatment Center', 'geoPoint': {'lat': 37.65466, 'lon': -122.40775}}, {'zip': '19713', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Helen F Graham Cancer Center', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '19718', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Christiana Care Health System-Christiana Hospital', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '19971', 'city': 'Rehoboth Beach', 'state': 'Delaware', 'country': 'United States', 'facility': 'Beebe Health Campus', 'geoPoint': {'lat': 38.72095, 'lon': -75.07601}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'MedStar Georgetown University Hospital', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Augusta University Medical Center', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '83712', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': "Saint Luke's Cancer Institute - Boise", 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '83619', 'city': 'Fruitland', 'state': 'Idaho', 'country': 'United States', 'facility': "Saint Luke's Cancer Institute - Fruitland", 'geoPoint': {'lat': 44.00766, 'lon': -116.91655}}, {'zip': '83642', 'city': 'Meridian', 'state': 'Idaho', 'country': 'United States', 'facility': "Saint Luke's Cancer Institute - Meridian", 'geoPoint': {'lat': 43.61211, 'lon': -116.39151}}, {'zip': '83687', 'city': 'Nampa', 'state': 'Idaho', 'country': 'United States', 'facility': "Saint Luke's Cancer Institute - Nampa", 'geoPoint': {'lat': 43.54072, 'lon': -116.56346}}, {'zip': '83301', 'city': 'Twin Falls', 'state': 'Idaho', 'country': 'United States', 'facility': "Saint Luke's Cancer Institute - Twin Falls", 'geoPoint': {'lat': 42.56297, 'lon': -114.46087}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'John H Stroger Jr Hospital of Cook County', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '61832', 'city': 'Danville', 'state': 'Illinois', 'country': 'United States', 'facility': 'Carle at The Riverfront', 'geoPoint': {'lat': 40.12448, 'lon': -87.63002}}, {'zip': '62526', 'city': 'Decatur', 'state': 'Illinois', 'country': 'United States', 'facility': 'Cancer Care Specialists of Illinois - Decatur', 'geoPoint': {'lat': 39.84031, 'lon': -88.9548}}, {'zip': '62526', 'city': 'Decatur', 'state': 'Illinois', 'country': 'United States', 'facility': 'Decatur Memorial Hospital', 'geoPoint': {'lat': 39.84031, 'lon': -88.9548}}, {'zip': '62401', 'city': 'Effingham', 'state': 'Illinois', 'country': 'United States', 'facility': 'Carle Physician Group-Effingham', 'geoPoint': {'lat': 39.12004, 'lon': -88.54338}}, {'zip': '62401', 'city': 'Effingham', 'state': 'Illinois', 'country': 'United States', 'facility': 'Crossroads Cancer Center', 'geoPoint': {'lat': 39.12004, 'lon': -88.54338}}, {'zip': '61938', 'city': 'Mattoon', 'state': 'Illinois', 'country': 'United States', 'facility': 'Carle Physician Group-Mattoon/Charleston', 'geoPoint': {'lat': 39.48309, 'lon': -88.37283}}, {'zip': '62864', 'city': 'Mount Vernon', 'state': 'Illinois', 'country': 'United States', 'facility': 'SSM Health Good Samaritan', 'geoPoint': {'lat': 38.31727, 'lon': -88.90312}}, {'zip': '61801', 'city': 'Urbana', 'state': 'Illinois', 'country': 'United States', 'facility': 'Carle Cancer Center', 'geoPoint': {'lat': 40.11059, 'lon': -88.20727}}, {'zip': '52402', 'city': 'Cedar Rapids', 'state': 'Iowa', 'country': 'United States', 'facility': "Saint Luke's Hospital", 'geoPoint': {'lat': 42.00833, 'lon': -91.64407}}, {'zip': '66205', 'city': 'Fairway', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Clinical Research Center', 'geoPoint': {'lat': 39.02223, 'lon': -94.6319}}, {'zip': '66112', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Cancer Center-West', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Cancer Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '66210', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Cancer Center-Overland Park', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '66606', 'city': 'Topeka', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Health System Saint Francis Campus', 'geoPoint': {'lat': 39.04833, 'lon': -95.67804}}, {'zip': '66205', 'city': 'Westwood', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Hospital-Westwood Cancer Center', 'geoPoint': {'lat': 39.04056, 'lon': -94.6169}}, {'zip': '04530', 'city': 'Bath', 'state': 'Maine', 'country': 'United States', 'facility': 'MaineHealth Coastal Cancer Treatment Center', 'geoPoint': {'lat': 43.91064, 'lon': -69.8206}}, {'zip': '04102', 'city': 'Portland', 'state': 'Maine', 'country': 'United States', 'facility': 'MaineHealth Maine Medical Center - Portland', 'geoPoint': {'lat': 43.65737, 'lon': -70.2589}}, {'zip': '04073', 'city': 'Sanford', 'state': 'Maine', 'country': 'United States', 'facility': 'MaineHealth Cancer Care Center of York County', 'geoPoint': {'lat': 43.43925, 'lon': -70.77422}}, {'zip': '04074', 'city': 'Scarborough', 'state': 'Maine', 'country': 'United States', 'facility': 'MaineHealth Maine Medical Center- Scarborough', 'geoPoint': {'lat': 43.57814, 'lon': -70.32172}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Corewell Health Grand Rapids Hospitals - Butterworth Hospital', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '55109', 'city': 'Maplewood', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minnesota Oncology Hematology PA-Maplewood', 'geoPoint': {'lat': 44.95302, 'lon': -92.99522}}, {'zip': '64154', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'University of Kansas Cancer Center - North', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '64064', 'city': "Lee's Summit", 'state': 'Missouri', 'country': 'United States', 'facility': "University of Kansas Cancer Center - Lee's Summit", 'geoPoint': {'lat': 38.91084, 'lon': -94.38217}}, {'zip': '64116', 'city': 'North Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'University of Kansas Cancer Center at North Kansas City Hospital', 'geoPoint': {'lat': 39.13, 'lon': -94.56218}}, {'zip': '65401', 'city': 'Rolla', 'state': 'Missouri', 'country': 'United States', 'facility': 'Phelps Health Delbert Day Cancer Institute', 'geoPoint': {'lat': 37.95143, 'lon': -91.77127}}, {'zip': '65807', 'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'CoxHealth South Hospital', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '89703', 'city': 'Carson City', 'state': 'Nevada', 'country': 'United States', 'facility': 'Carson Tahoe Regional Medical Center', 'geoPoint': {'lat': 39.1638, 'lon': -119.7674}}, {'zip': '89052', 'city': 'Henderson', 'state': 'Nevada', 'country': 'United States', 'facility': 'OptumCare Cancer Care at Seven Hills', 'geoPoint': {'lat': 36.0397, 'lon': -114.98194}}, {'zip': '89102', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'OptumCare Cancer Care at Charleston', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '89128', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'OptumCare Cancer Care at MountainView', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '89144', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Comprehensive Cancer Centers of Nevada - Town Center', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '89148', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Comprehensive Cancer Centers of Nevada', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '89148', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'OptumCare Cancer Care at Fort Apache', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '89169', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Comprehensive Cancer Centers of Nevada - Central Valley', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '08822', 'city': 'Flemington', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hunterdon Medical Center', 'geoPoint': {'lat': 40.51233, 'lon': -74.85933}}, {'zip': '07960', 'city': 'Morristown', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Morristown Medical Center', 'geoPoint': {'lat': 40.79677, 'lon': -74.48154}}, {'zip': '87106', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico Cancer Center', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '28054', 'city': 'Gastonia', 'state': 'North Carolina', 'country': 'United States', 'facility': 'CaroMont Regional Medical Center', 'geoPoint': {'lat': 35.26208, 'lon': -81.1873}}, {'zip': '28374', 'city': 'Pinehurst', 'state': 'North Carolina', 'country': 'United States', 'facility': 'FirstHealth of the Carolinas-Moore Regional Hospital', 'geoPoint': {'lat': 35.19543, 'lon': -79.46948}}, {'zip': '28462', 'city': 'Supply', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Novant Cancer Institute Radiation Oncology - Supply', 'geoPoint': {'lat': 34.01767, 'lon': -78.2675}}, {'zip': '28401', 'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Novant Health Cancer Institute Radiation Oncology - Wilmington', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'zip': '28401', 'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Novant Health New Hanover Regional Medical Center', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'zip': '45601', 'city': 'Chillicothe', 'state': 'Ohio', 'country': 'United States', 'facility': 'Adena Regional Medical Center', 'geoPoint': {'lat': 39.33312, 'lon': -82.9824}}, {'zip': '45801', 'city': 'Lima', 'state': 'Ohio', 'country': 'United States', 'facility': "Saint Rita's Medical Center", 'geoPoint': {'lat': 40.74255, 'lon': -84.10523}}, {'zip': '19317', 'city': 'Chadds Ford', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Christiana Care Health System-Concord Health Center', 'geoPoint': {'lat': 39.87178, 'lon': -75.59132}}, {'zip': '17822', 'city': 'Danville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Geisinger Medical Center', 'geoPoint': {'lat': 40.96342, 'lon': -76.61273}}, {'zip': '29621', 'city': 'Anderson', 'state': 'South Carolina', 'country': 'United States', 'facility': 'AnMed Health Cancer Center', 'geoPoint': {'lat': 34.50344, 'lon': -82.65013}}, {'zip': '29601', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Saint Francis Hospital', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '29605', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Prisma Health Cancer Institute - Faris', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '29605', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Prisma Health Greenville Memorial Hospital', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '29607', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Saint Francis Cancer Center', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '29615', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Prisma Health Cancer Institute - Eastside', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '29650', 'city': 'Greer', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Prisma Health Cancer Institute - Greer', 'geoPoint': {'lat': 34.93873, 'lon': -82.22706}}, {'zip': '29651', 'city': 'Greer', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Gibbs Cancer Center-Pelham', 'geoPoint': {'lat': 34.93873, 'lon': -82.22706}}, {'zip': '29672', 'city': 'Seneca', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Prisma Health Cancer Institute - Seneca', 'geoPoint': {'lat': 34.68566, 'lon': -82.9532}}, {'zip': '29303', 'city': 'Spartanburg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Spartanburg Medical Center', 'geoPoint': {'lat': 34.94957, 'lon': -81.93205}}, {'zip': '54915', 'city': 'Appleton', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Ascension Saint Elizabeth Hospital', 'geoPoint': {'lat': 44.26193, 'lon': -88.41538}}, {'zip': '53045', 'city': 'Brookfield', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Ascension Southeast Wisconsin Hospital - Elmbrook Campus', 'geoPoint': {'lat': 43.06057, 'lon': -88.10648}}, {'zip': '54904', 'city': 'Oshkosh', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Ascension Mercy Hospital', 'geoPoint': {'lat': 44.02471, 'lon': -88.54261}}, {'zip': '54401', 'city': 'Wausau', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Aspirus Regional Cancer Center', 'geoPoint': {'lat': 44.95914, 'lon': -89.63012}}], 'overallOfficials': [{'name': 'Ronald C Chen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NRG Oncology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NRG Oncology', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}