Ignite Creation Date:
2025-12-24 @ 9:50 PM
Ignite Modification Date:
2026-01-04 @ 4:41 AM
Study NCT ID:
NCT05609032
Status:
COMPLETED
Last Update Posted:
2024-11-06
First Post:
2022-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Development and Pilot Testing of the Sense2Quit App
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}, {'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D064424', 'term': 'Tobacco Use'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rb897@cumc.columbia.edu', 'phone': '212-342-6886', 'title': 'Rebecca Schnall, PhD, MPH, RN-BC, FAAN, FACMI', 'organization': 'Columbia University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention (App Arm)', 'description': 'Participants randomized to the intervention arm will receive access to the Sense2Quit App (A multi-component intervention that links a smartphone app to a smartwatch to provide real-time quit reminders to curtail relapses and avoid potential triggers), standard smoking cessation counseling, and nicotine replacement therapy.\n\nSense2Quit App: Participants in the intervention arm will receive access to Sense2Quit, a smartphone app that links to a smartwatch.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'Participants randomized to the control arm will receive standard smoking cessation counseling and referral to quitline.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Biochemically Verified 7-day Point Prevalence Smoking/Tobacco Abstinence at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention (App Arm)', 'description': 'Participants randomized to the intervention arm will receive access to the Sense2Quit App (A multi-component intervention that links a smartphone app to a smartwatch to provide real-time quit reminders to curtail relapses and avoid potential triggers), standard smoking cessation counseling, and nicotine replacement therapy.\n\nSense2Quit App: Participants in the intervention arm will receive access to Sense2Quit, a smartphone app that links to a smartwatch.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants randomized to the control arm will receive standard smoking cessation counseling and referral to quitline.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks after baseline (or quit date if later than baseline visit)', 'description': '7-day point prevalence abstinence is calculated as the percentage of participants who reported no smoking/tobacco use in the 7 days prior to their 12-week follow-up visits biochemically verified by exhaled Carbon Monoxide (eCO) collected at 4 and 12 weeks via breathalyzer (Micro+TM basic Smokerlyzer®). At each of the 2 follow-up timepoints, participants with eCO levels \\<5 parts per million (ppm) will be classified as abstinent while participants with eCO levels ≥5ppm will be classified as not abstinent.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '28 of the 29 control arm participants analyzed as the smokerlyzer data was not collected from one participant at the 12 week timepoint'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention (App Arm)', 'description': 'Participants randomized to the intervention arm will receive access to the Sense2Quit App (A multi-component intervention that links a smartphone app to a smartwatch to provide real-time quit reminders to curtail relapses and avoid potential triggers), standard smoking cessation counseling, and nicotine replacement therapy.\n\nSense2Quit App: Participants in the intervention arm will receive access to Sense2Quit, a smartphone app that links to a smartwatch.'}, {'id': 'FG001', 'title': 'Control', 'description': 'Participants randomized to the control arm will receive standard smoking cessation counseling and referral to quitline.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention (App Arm)', 'description': 'Participants randomized to the intervention arm will receive access to the Sense2Quit App (A multi-component intervention that links a smartphone app to a smartwatch to provide real-time quit reminders to curtail relapses and avoid potential triggers), standard smoking cessation counseling, and nicotine replacement therapy.\n\nSense2Quit App: Participants in the intervention arm will receive access to Sense2Quit, a smartphone app that links to a smartwatch.'}, {'id': 'BG001', 'title': 'Control', 'description': 'Participants randomized to the control arm will receive standard smoking cessation counseling and referral to quitline.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.97', 'spread': '12.05', 'groupId': 'BG000'}, {'value': '58.83', 'spread': '7.90', 'groupId': 'BG001'}, {'value': '56.40', 'spread': '10.40', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}, {'title': 'Female', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}, {'title': 'Transgender Female/Transwoman/Male-to-Female', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black/African American', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Multiracial', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Education', 'classes': [{'categories': [{'title': 'None', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Some high school, no diploma', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'High school diploma or equivalent', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Some College', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Associate degree or technical degree', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Bachelor/college degree', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Professional or graduate degree', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Annual Income', 'classes': [{'categories': [{'title': 'Less than $10,000', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': '$10,000-$19,999', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': '$20,000-$39,999', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': '$40,000-$59,999', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': "Don't know", 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sexual Orientation', 'classes': [{'categories': [{'title': 'Homosexual/gay/lesbian', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Heterosexual/straight', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'Bisexual', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Asexual', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-09-18', 'size': 807510, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-10-11T16:15', 'hasProtocol': True}, {'date': '2024-02-21', 'size': 239477, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-10-11T16:19', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Intervention assignment will be masked to participants only'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-01-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-15', 'studyFirstSubmitDate': '2022-07-14', 'resultsFirstSubmitDate': '2024-10-15', 'studyFirstSubmitQcDate': '2022-11-04', 'lastUpdatePostDateStruct': {'date': '2024-11-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-15', 'studyFirstPostDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Biochemically Verified 7-day Point Prevalence Smoking/Tobacco Abstinence at 12 Weeks', 'timeFrame': '12 weeks after baseline (or quit date if later than baseline visit)', 'description': '7-day point prevalence abstinence is calculated as the percentage of participants who reported no smoking/tobacco use in the 7 days prior to their 12-week follow-up visits biochemically verified by exhaled Carbon Monoxide (eCO) collected at 4 and 12 weeks via breathalyzer (Micro+TM basic Smokerlyzer®). At each of the 2 follow-up timepoints, participants with eCO levels \\<5 parts per million (ppm) will be classified as abstinent while participants with eCO levels ≥5ppm will be classified as not abstinent.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sense2Quit', 'Tobacco Use'], 'conditions': ['Smoking Cessation', 'HIV Infections']}, 'referencesModule': {'references': [{'pmid': '40000581', 'type': 'DERIVED', 'citation': 'Schnall R, Huang MC, Brin M, Cioe PA, Liu J, Das A, Fontalvo S, Xu W. Feasibility and Acceptability of the Sense2Quit App for Improving Smoking Cessation in PWH. AIDS Behav. 2025 Jun;29(6):1920-1929. doi: 10.1007/s10461-025-04659-1. Epub 2025 Feb 25.'}, {'pmid': '37856173', 'type': 'DERIVED', 'citation': 'Brin M, Trujillo P, Jia H, Cioe P, Huang MC, Chen H, Qian X, Xu W, Schnall R. Pilot Testing of an mHealth App for Tobacco Cessation in People Living With HIV: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2023 Oct 19;12:e49558. doi: 10.2196/49558.'}]}, 'descriptionModule': {'briefSummary': 'This is a pilot randomized controlled trial to examine the feasibility, acceptability and preliminary efficacy of the Sense2Quit App in a sample of 60 PLWH who smoke.', 'detailedDescription': "The estimated 40-70% of persons living with HIV (PLWH) who smoke cigarettes experience substantial tobacco-related morbidity and mortality. For PLWH, apart from achieving and maintaining a suppressed viral load, tobacco cessation is the most important health behavior they can undertake to maximize both quality of life and life expectancy. However, the currently available evidence for improving tobacco cessation among PLWH is inadequate. Few tobacco cessation interventions have been tested among PLWH, and of those which have, there is 'very low' quality evidence that they were effective in the short-term and 'moderate' quality evidence indicating similar outcomes to controls in the long-term. Thus, it is critical to develop evidence-based tobacco cessation interventions to address the complex and unique needs of PLWH. In response to this need, the investigators propose to develop a mobile intervention for PLWH who smoke building on Sense2Quit, a multi-component intervention that links a smartphone app to a smartwatch to provide real-time quit reminders to curtail relapses and avoid potential trigger. This real-time feedback is critical especially in the first few weeks of a quit attempt.\n\nThe proposed Sense2Quit intervention for PLWH who smoke cigarettes is a novel and evidence-driven intervention using mobile technology to improve tobacco cessation. This will be the first study to develop and pilot test an innovative tobacco cessation intervention for PLWH. The final product of this study will be the basis for an R01 application to conduct a large-scale efficacy study for this population.\n\nThe investigators are confident that the proposed intervention will be a high impact intervention for improving tobacco cessation among PLWH and have long-term implications for overall improvement in the public's health."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PLWH confirmed through medical records or pill bottles for antiretroviral therapy (ART)medications.\n* ≥ 18 years of age;\n* Own an Android smartphone;\n* Understand and read English;\n* Not pregnant or breastfeeding (due to contraindications for Nicotine Replacement Therapy \\[NRT\\]);\n* Permanent contact information;\n* Smokes ≥5 cigarettes per day for the past 30 days;\n* Interested in quitting smoking within 30 days;\n* Blows ≥5 ppm eCO into a breath analyzer at baseline.\n\nExclusion Criteria:\n\n* Use of tobacco products other than cigarettes (i.e. cigars, piped tobacco, chew, snuff)\n* Planning to move within 3 months of enrollment;\n* Positive history of a medical condition that precludes nicotine patch use;\n* Current use of NRT or other smoking cessation medications (e.g., Chantix or Zyban);\n* Current enrollment in another smoking cessation program.\n* Alcohol dependence measured through the AUDIT-C\n* A household member is also participating in the Sense2Quit study (due to study contamination).'}, 'identificationModule': {'nctId': 'NCT05609032', 'briefTitle': 'Development and Pilot Testing of the Sense2Quit App', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'Development and Pilot Testing of the Sense2Quit App', 'orgStudyIdInfo': {'id': 'AAAT7031'}, 'secondaryIdInfos': [{'id': '1R21CA265961-01', 'link': 'https://reporter.nih.gov/quickSearch/1R21CA265961-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention (App Arm)', 'description': 'Participants randomized to the intervention arm will receive access to the Sense2Quit App (A multi-component intervention that links a smartphone app to a smartwatch to provide real-time quit reminders to curtail relapses and avoid potential triggers), standard smoking cessation counseling, and nicotine replacement therapy.', 'interventionNames': ['Behavioral: Sense2Quit App']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Participants randomized to the control arm will receive standard smoking cessation counseling and referral to quitline.'}], 'interventions': [{'name': 'Sense2Quit App', 'type': 'BEHAVIORAL', 'description': 'Participants in the intervention arm will receive access to Sense2Quit, a smartphone app that links to a smartwatch.', 'armGroupLabels': ['Intervention (App Arm)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Irving Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Rebecca Schnall, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Case Western Reserve University', 'class': 'OTHER'}, {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Mary Dickey Lindsay Professor of Disease Prevention and Health Promotion', 'investigatorFullName': 'Rebecca Schnall, RN, MPH, PhD', 'investigatorAffiliation': 'Columbia University'}}}}