Viewing Study NCT04161157


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Study NCT ID: NCT04161157
Status: COMPLETED
Last Update Posted: 2023-10-05
First Post: 2019-11-08
Is NOT Gene Therapy: False
Has Adverse Events: True

Brief Title: Piloting Pathways With Lung Cancer Patients
Sponsor:
Organization:

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'laurie.mclouth@uky.edu', 'phone': '859-562-2526', 'title': 'Dr. Laurie McLouth', 'organization': 'University of Kentucky'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '24 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Pathways', 'description': 'Pathways is designed to help patients identify and pursue values-based goals and address potential goal obstacles, including lung cancer stigma.\n\nPathways: Goal-setting intervention to help patients identify personal values, value-consistent goals, and ways to pursue goals and address goal obstacles. Although potential refinements may occur based on aim 1 (refining procedures and content with 6 patients), Pathways is designed to consist primarily of 2 in-person sessions (\\~30-60 minutes) delivered when patients are in clinic for cancer treatment, with supporting phone calls and contact in between sessions.', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 0, 'seriousNumAtRisk': 53, 'deathsNumAffected': 3, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Feasibility of Enrollment: Percentage of Eligible and Approached Patients Who Agree to Participate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pathways', 'description': 'Pathways is designed to help patients identify and pursue values-based goals and address potential goal obstacles, including lung cancer stigma.\n\nPathways: Goal-setting intervention to help patients identify personal values, value-consistent goals, and ways to pursue goals and address goal obstacles. Although potential refinements may occur based on aim 1 (refining procedures and content with 6 patients), Pathways is designed to consist primarily of 2 in-person sessions (\\~30-60 minutes) delivered when patients are in clinic for cancer treatment, with supporting phone calls and contact in between sessions.'}], 'classes': [{'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '9 months', 'description': 'Percentage of eligible and approached patients who agree to participate', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '98 potentially eligible people were approached, of whom 53 agreed to participate.'}, {'type': 'PRIMARY', 'title': 'Acceptability: Ratings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pathways', 'description': 'Pathways is designed to help patients identify and pursue values-based goals and address potential goal obstacles, including lung cancer stigma.\n\nPathways: Goal-setting intervention to help patients identify personal values, value-consistent goals, and ways to pursue goals and address goal obstacles. Although potential refinements may occur based on aim 1 (refining procedures and content with 6 patients), Pathways is designed to consist primarily of 2 in-person sessions (\\~30-60 minutes) delivered when patients are in clinic for cancer treatment, with supporting phone calls and contact in between sessions.'}], 'classes': [{'title': 'Convenience of intervention', 'categories': [{'measurements': [{'value': '8.79', 'spread': '1.17', 'groupId': 'OG000'}]}]}, {'title': 'Relevance of intervention', 'categories': [{'measurements': [{'value': '8.46', 'spread': '1.67', 'groupId': 'OG000'}]}]}, {'title': 'Helpfulness of intervention', 'categories': [{'measurements': [{'value': '8.54', 'spread': '1.55', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '9 months', 'description': 'Mean acceptability ratings on individual items of acceptability developed by study team (e.g., convenience of the intervention, helpfulness of the intervention, relevance of the intervention; scores of at least 7/10 on each item, possible range = 1-10, higher scores indicate higher acceptability).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '1 participant skipped this measure so overall number is 39 instead of 40'}, {'type': 'SECONDARY', 'title': 'PROMIS Satisfaction With Participation in Social Roles - Short Form 8a', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pathways', 'description': 'Pathways is designed to help patients identify and pursue values-based goals and address potential goal obstacles, including lung cancer stigma.\n\nPathways: Goal-setting intervention to help patients identify personal values, value-consistent goals, and ways to pursue goals and address goal obstacles. Although potential refinements may occur based on aim 1 (refining procedures and content with 6 patients), Pathways is designed to consist primarily of 2 in-person sessions (\\~30-60 minutes) delivered when patients are in clinic for cancer treatment, with supporting phone calls and contact in between sessions.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.8', 'spread': '9.54', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '9 months', 'description': 'Brief measure of satisfaction with ability and participation in activities and roles (e.g., work at home, regular personal and household responsibilities, do things for family) Higher scores indicate more satisfaction with participation. Raw scores range from 8 to 40. 8 items are responded to on a scale of 1 = not at all to 5 = very much.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hope - State Hope Scale (Snyder)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pathways', 'description': 'Pathways is designed to help patients identify and pursue values-based goals and address potential goal obstacles, including lung cancer stigma.\n\nPathways: Goal-setting intervention to help patients identify personal values, value-consistent goals, and ways to pursue goals and address goal obstacles. Although potential refinements may occur based on aim 1 (refining procedures and content with 6 patients), Pathways is designed to consist primarily of 2 in-person sessions (\\~30-60 minutes) delivered when patients are in clinic for cancer treatment, with supporting phone calls and contact in between sessions.'}], 'classes': [{'categories': [{'measurements': [{'value': '31.3', 'spread': '7.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '9 months', 'description': 'Brief measure of agency and pathways thinking. 6 items responded to on a scale of 1 = definitely false to 8 = definitely true. Items are summed for a total score (possible range = 6 - 48). Higher scores indicate higher hope.', 'unitOfMeasure': 'total score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Purpose - PROMIS Meaning and Purpose 4a', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pathways', 'description': 'Pathways is designed to help patients identify and pursue values-based goals and address potential goal obstacles, including lung cancer stigma.\n\nPathways: Goal-setting intervention to help patients identify personal values, value-consistent goals, and ways to pursue goals and address goal obstacles. Although potential refinements may occur based on aim 1 (refining procedures and content with 6 patients), Pathways is designed to consist primarily of 2 in-person sessions (\\~30-60 minutes) delivered when patients are in clinic for cancer treatment, with supporting phone calls and contact in between sessions.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.4', 'spread': '3.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '9 months', 'description': "Brief measure assessing one's sense of purpose and that there are reasons for living; 4 items responded to on a scale of 1 = not at all to 5 = very much (possible raw score range = 4 - 20). Higher scores indicate greater meaning and purpose.", 'unitOfMeasure': 'total raw score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '1 participant skipped this measure so overall number is 39 instead of 40'}, {'type': 'SECONDARY', 'title': 'Distress - PROMIS Depression Short Form 6a', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pathways', 'description': 'Pathways is designed to help patients identify and pursue values-based goals and address potential goal obstacles, including lung cancer stigma.\n\nPathways: Goal-setting intervention to help patients identify personal values, value-consistent goals, and ways to pursue goals and address goal obstacles. Although potential refinements may occur based on aim 1 (refining procedures and content with 6 patients), Pathways is designed to consist primarily of 2 in-person sessions (\\~30-60 minutes) delivered when patients are in clinic for cancer treatment, with supporting phone calls and contact in between sessions.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.3', 'spread': '5.87', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '9 months', 'description': 'Brief measure assessing sense of worthlessness, helplessness, depression, etc. 6 items are responded to on a scale of 1 = never to 5 = always (possible raw scores range from 6-30). Higher scores indicate greater distress.', 'unitOfMeasure': 'total raw score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '1 participant skipped this measure so overall number is 39 instead of 40'}, {'type': 'SECONDARY', 'title': 'Lung Cancer Stigma - Lung Cancer Stigma Inventory (Hamann)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pathways', 'description': 'Pathways is designed to help patients identify and pursue values-based goals and address potential goal obstacles, including lung cancer stigma.\n\nPathways: Goal-setting intervention to help patients identify personal values, value-consistent goals, and ways to pursue goals and address goal obstacles. Although potential refinements may occur based on aim 1 (refining procedures and content with 6 patients), Pathways is designed to consist primarily of 2 in-person sessions (\\~30-60 minutes) delivered when patients are in clinic for cancer treatment, with supporting phone calls and contact in between sessions.'}], 'classes': [{'categories': [{'measurements': [{'value': '52', 'spread': '15.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '9 months', 'description': 'measure of lung cancer stigma. 25 items making up three subscales (perceived stigma, internalized stigma, and constrained disclosure). Items are responded to on a scale of 1 = not at all to 5 = extremely. Items are summed, with a higher score indicating greater lung cancer stigma/worse outcome (possible total score range = 25-125) . Clinical cutoff of a total score of 37.5 is suggested in literature as significant levels of stigma.', 'unitOfMeasure': 'total score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pathways', 'description': 'Pathways is designed to help patients identify and pursue values-based goals and address potential goal obstacles, including lung cancer stigma.\n\nPathways: Goal-setting intervention to help patients identify personal values, value-consistent goals, and ways to pursue goals and address goal obstacles. Although potential refinements may occur based on aim 1 (refining procedures and content with 6 patients), Pathways is designed to consist primarily of 2 in-person sessions (\\~30-60 minutes) delivered when patients are in clinic for cancer treatment, with supporting phone calls and contact in between sessions.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Ineligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Pathways', 'description': 'Pathways is designed to help patients identify and pursue values-based goals and address potential goal obstacles, including lung cancer stigma.\n\nPathways: Goal-setting intervention to help patients identify personal values, value-consistent goals, and ways to pursue goals and address goal obstacles. Although potential refinements may occur based on aim 1 (refining procedures and content with 6 patients), Pathways is designed to consist primarily of 2 in-person sessions (\\~30-60 minutes) delivered when patients are in clinic for cancer treatment, with supporting phone calls and contact in between sessions.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.4', 'spread': '10.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '1 participant dropped from the study before baseline measures were collected.'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '1 participant dropped from the study before baseline measures were collected.'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '52', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '1 participant dropped from the study before baseline measures were collected.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '44', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '53 participants were enrolled in the study; however, 1 participant dropped from the study before baseline measures were collected.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-01-18', 'size': 1177360, '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': '2023-07-28T14:23', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-03', 'studyFirstSubmitDate': '2019-11-08', 'resultsFirstSubmitDate': '2023-07-31', 'studyFirstSubmitQcDate': '2019-11-12', 'lastUpdatePostDateStruct': {'date': '2023-10-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-10-03', 'studyFirstPostDateStruct': {'date': '2019-11-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of Enrollment: Percentage of Eligible and Approached Patients Who Agree to Participate', 'timeFrame': '9 months', 'description': 'Percentage of eligible and approached patients who agree to participate'}, {'measure': 'Acceptability: Ratings', 'timeFrame': '9 months', 'description': 'Mean acceptability ratings on individual items of acceptability developed by study team (e.g., convenience of the intervention, helpfulness of the intervention, relevance of the intervention; scores of at least 7/10 on each item, possible range = 1-10, higher scores indicate higher acceptability).'}], 'secondaryOutcomes': [{'measure': 'PROMIS Satisfaction With Participation in Social Roles - Short Form 8a', 'timeFrame': '9 months', 'description': 'Brief measure of satisfaction with ability and participation in activities and roles (e.g., work at home, regular personal and household responsibilities, do things for family) Higher scores indicate more satisfaction with participation. Raw scores range from 8 to 40. 8 items are responded to on a scale of 1 = not at all to 5 = very much.'}, {'measure': 'Hope - State Hope Scale (Snyder)', 'timeFrame': '9 months', 'description': 'Brief measure of agency and pathways thinking. 6 items responded to on a scale of 1 = definitely false to 8 = definitely true. Items are summed for a total score (possible range = 6 - 48). Higher scores indicate higher hope.'}, {'measure': 'Purpose - PROMIS Meaning and Purpose 4a', 'timeFrame': '9 months', 'description': "Brief measure assessing one's sense of purpose and that there are reasons for living; 4 items responded to on a scale of 1 = not at all to 5 = very much (possible raw score range = 4 - 20). Higher scores indicate greater meaning and purpose."}, {'measure': 'Distress - PROMIS Depression Short Form 6a', 'timeFrame': '9 months', 'description': 'Brief measure assessing sense of worthlessness, helplessness, depression, etc. 6 items are responded to on a scale of 1 = never to 5 = always (possible raw scores range from 6-30). Higher scores indicate greater distress.'}, {'measure': 'Lung Cancer Stigma - Lung Cancer Stigma Inventory (Hamann)', 'timeFrame': '9 months', 'description': 'measure of lung cancer stigma. 25 items making up three subscales (perceived stigma, internalized stigma, and constrained disclosure). Items are responded to on a scale of 1 = not at all to 5 = extremely. Items are summed, with a higher score indicating greater lung cancer stigma/worse outcome (possible total score range = 25-125) . Clinical cutoff of a total score of 37.5 is suggested in literature as significant levels of stigma.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metastatic Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to determine the feasibility of a new supportive intervention, called Pathways, for patients with advanced stage and metastatic lung cancer.', 'detailedDescription': 'In this study, investigators will first test the Pathways procedures with 6 patients to identify any improvements that need to be made. Then, investigators will test the feasibility of the Pathways intervention with 20 patients who are undergoing cancer treatment for advanced stage or metastatic lung cancer. Pathways is designed to help patients set and pursue personal goals during lung cancer treatment. In this study, investigators want to see if they can recruit patients with lung cancer who are being treated at the University of Kentucky Markey Cancer Center to participate in the Pathways intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* new or recurrent stage IIIB, stage IIIC or stage IV non-small cell lung cancer (NSCLC) or extensive stage SCLC\n* 18 years of age or older\n* ECOG PS 0-2/Karnofsky 60-100\n* 3 to 12 weeks into active cancer treatment\n\nExclusion Criteria:\n\n* unstable brain metastases\n* cognitive or psychiatric condition for which participating would be inappropriate\n* unable to speak and read English'}, 'identificationModule': {'nctId': 'NCT04161157', 'briefTitle': 'Piloting Pathways With Lung Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Kentucky'}, 'officialTitle': 'Piloting Pathways, a Hope-enhancing Intervention to Address Activity and Role Function in Metastatic Lung Cancer Patients', 'orgStudyIdInfo': {'id': '52168'}, 'secondaryIdInfos': [{'id': 'R03CA235171-01A1', 'link': 'https://reporter.nih.gov/quickSearch/R03CA235171-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pathways', 'description': 'Pathways is designed to help patients identify and pursue values-based goals and address potential goal obstacles, including lung cancer stigma.', 'interventionNames': ['Behavioral: Pathways']}], 'interventions': [{'name': 'Pathways', 'type': 'BEHAVIORAL', 'description': 'Goal-setting intervention to help patients identify personal values, value-consistent goals, and ways to pursue goals and address goal obstacles. Although potential refinements may occur based on aim 1 (refining procedures and content with 6 patients), Pathways is designed to consist primarily of 2 in-person sessions (\\~30-60 minutes) delivered when patients are in clinic for cancer treatment, with supporting phone calls and contact in between sessions.', 'armGroupLabels': ['Pathways']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40506', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}], 'overallOfficials': [{'name': 'Laurie McLouth, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kentucky'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laurie McLouth', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Laurie McLouth', 'investigatorAffiliation': 'University of Kentucky'}}}}