Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-26 @ 3:50 AM
Study NCT ID:
NCT01210118
Status:
COMPLETED
Last Update Posted:
2013-04-09
First Post:
2010-09-23
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Interventions of Smoking Cessation During Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pbehraki@hsph.harvard.edu', 'phone': '00302106470056', 'title': 'Professor Panagiotis Behrakis', 'organization': 'Hellenic Anticancer Society'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'High Intensity Intervention', 'description': 'Experimental group participants received a higher intensity intervention, which include: 30 minutes of individualized cognitive-behavioural counselling delivered by a trained health care professional and a self-help manual especially tailored for smoking cessation during pregnancy. Counseling was based at the "5 Αs" (Ask,Advise, Asses, Assist, Arrange). In addition to counselling, a self help manual especially tailored for smoking cessation during pregnancy for Greek women was provided.', 'otherNumAtRisk': 42, 'otherNumAffected': 0, 'seriousNumAtRisk': 42, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Low Intensity Intervention', 'description': 'Control group participants received a face to face low intensity intervention which lasted 5 minutes and included brief advice and the provision of a leaflet on smoking and pregnancy. This leaflet summarized the main effects of smoking during pregnancy and gave clear short messages for encouraging smoking cessation by setting up a quit date.', 'otherNumAtRisk': 42, 'otherNumAffected': 0, 'seriousNumAtRisk': 42, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Participants' Smoking Status", 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Intensity Intervention', 'description': 'Experimental group participants received a higher intensity intervention, which include: 30 minutes of individualized cognitive-behavioural counselling delivered by a trained health care professional and a self-help manual especially tailored for smoking cessation during pregnancy. Counseling was based at the "5 Αs" (Ask,Advise, Asses, Assist, Arrange). In addition to counselling, a self help manual especially tailored for smoking cessation during pregnancy for Greek women was provided.'}, {'id': 'OG001', 'title': 'Low Intensity Intervention', 'description': 'Control group participants received a face to face low intensity intervention which lasted 5 minutes and included brief advice and the provision of a leaflet on smoking and pregnancy. This leaflet summarized the main effects of smoking during pregnancy and gave clear short messages for encouraging smoking cessation by setting up a quit date.'}], 'classes': [{'title': 'Urine nicotine', 'categories': [{'measurements': [{'value': '253.6', 'spread': '532.3', 'groupId': 'OG000'}, {'value': '678.9', 'spread': '1467.2', 'groupId': 'OG001'}]}]}, {'title': 'Urine cotinine', 'categories': [{'measurements': [{'value': '311.9', 'spread': '490.1', 'groupId': 'OG000'}, {'value': '479.6', 'spread': '563.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'around the 32nd week of gestation.', 'description': "participants' smoking status was validated by urine cotinine and urine nicotine", 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only the participants who met the inclusion criteria and completed the research protocol were included in the research analysis'}, {'type': 'SECONDARY', 'title': 'Birth Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Intensity Intervention', 'description': 'Experimental group participants received a higher intensity intervention, which include: 30 minutes of individualized cognitive-behavioural counselling delivered by a trained health care professional and a self-help manual especially tailored for smoking cessation during pregnancy. Counseling was based at the'}, {'id': 'OG001', 'title': 'Low Intensity Intervention', 'description': 'Control group participants received a face to face low intensity intervention which lasted 5 minutes and included brief advice and the provision of a leaflet on smoking and pregnancy. This leaflet summarized the main effects of smoking during pregnancy and gave clear short messages for encouraging smoking cessation by setting up a quit date.'}], 'classes': [{'categories': [{'measurements': [{'value': '3,003.4', 'spread': '499.8', 'groupId': 'OG000'}, {'value': '3,231.3', 'spread': '450.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After child birth', 'description': "Infants' birth weight was recorded.", 'unitOfMeasure': 'birth weight in grams', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only the participants who met the inclusion criteria and completed the research protocol were included in the research analysis.'}, {'type': 'PRIMARY', 'title': 'The Effectiveness of the Interventions According the Levels of Urine Cotinine Before and After Intervention.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Intensity Intervention', 'description': 'Experimental group participants received a higher intensity intervention, which included: 30 minutes of individualized cognitive-behavioural counselling delivered by a trained health care professional and a self-help manual especially tailored for smoking cessation during pregnancy. Counseling was based at the "5 Αs" (Ask,Advise, Asses, Assist, Arrange). In addition to counselling, a self help manual especially tailored for smoking cessation during pregnancy for Greek women was provided.'}, {'id': 'OG001', 'title': 'Low Intensity Intervention', 'description': 'Control group participants received a face to face low intensity intervention which lasted 5 minutes and included brief advice and the provision of a leaflet on smoking and pregnancy. This leaflet summarized the main effects of smoking during pregnancy and gave clear short messages for encouraging smoking cessation by setting up a quit date.'}], 'classes': [{'title': 'Before Intervention (baseline)', 'categories': [{'measurements': [{'value': '11.9', 'groupId': 'OG000', 'lowerLimit': '0.001', 'upperLimit': '0.001'}, {'value': '21.4', 'groupId': 'OG001', 'lowerLimit': '0.001', 'upperLimit': '1.000'}]}]}, {'title': 'After intervention (32nd week of gestation)', 'categories': [{'measurements': [{'value': '45.2', 'groupId': 'OG000'}, {'value': '21.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At the baseline and at the 32nd week of gestation', 'description': 'The basic primary outcomes of the study present the levels of urine cotinine before and after intervention separately for each group according to the cut of point that is used for the separation of active from passive smoking ,when urine cotinine ≤80ng/ml: there is biochemically validated smoking cessation.', 'unitOfMeasure': 'percentage of participants who quit', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Days of Prematurity of Birth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Intensity Intervention', 'description': 'Experimental group participants received a higher intensity intervention, which included: 30 minutes of individualized cognitive-behavioural counselling delivered by a trained health care professional and a self-help manual especially tailored for smoking cessation during pregnancy. Counseling was based at the'}, {'id': 'OG001', 'title': 'Low Intensity Intervention', 'description': 'Control group participants received a face to face low intensity intervention which lasted 5 minutes and included brief advice and the provision of a leaflet on smoking and pregnancy. This leaflet summarized the main effects of smoking during pregnancy and gave clear short messages for encouraging smoking cessation by setting up a quit date.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.3', 'spread': '11.6', 'groupId': 'OG000'}, {'value': '10.5', 'spread': '6.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After child birth', 'description': 'Days of prematurity of birth were recorded', 'unitOfMeasure': 'number of days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only the participants who met the inclusion criteria and completed the research protocol were included in the research analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'High Intensity Intervention', 'description': 'Experimental group participants received a higher intensity intervention, which included: 30 minutes of individualized cognitive-behavioural counselling delivered by a trained health care professional and a self-help manual especially tailored for smoking cessation during pregnancy. Counseling was based at the "5 Αs" (Ask,Advise, Asses, Assist, Arrange). In addition to counselling, a self help manual especially tailored for smoking cessation during pregnancy for Greek women was provided.'}, {'id': 'FG001', 'title': 'Low Intensity Intervention', 'description': 'Control group participants received a face to face low intensity intervention which lasted 5 minutes and included brief advice and the provision of a leaflet on smoking and pregnancy. This leaflet summarized the main effects of smoking during pregnancy and gave clear short messages for encouraging smoking cessation by setting up a quit date.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '42'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Spontaneous abortion', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': "This research took place in two hospitals situated in the area of Attici, Greece namely through the Peripheral General Maternity Hospital 'Helena Venizelos' and the Maternity Unit of the 'Attikon' University Hospital. Recruitment lasted from November 2009- February 2011.", 'preAssignmentDetails': 'Sixty-six enrolled participants were excluded from the trial before assignment to groups because 36 of them did not meet the inclusion criteria and 30 of them refused to participate.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'High Intensity Intervention', 'description': 'Experimental group participants received a higher intensity intervention, which include: 30 minutes of individualized cognitive-behavioural counselling delivered by a trained health care professional and a self-help manual especially tailored for smoking cessation during pregnancy. Counseling was based at the "5 Αs" (Ask,Advise, Asses, Assist, Arrange). In addition to counselling, a self help manual especially tailored for smoking cessation during pregnancy for Greek women was provided.'}, {'id': 'BG001', 'title': 'Low Intensity Intervention', 'description': 'Control group participants received a face to face low intensity intervention which lasted 5 minutes and included brief advice and the provision of a leaflet on smoking and pregnancy. This leaflet summarized the main effects of smoking during pregnancy and gave clear short messages for encouraging smoking cessation by setting up a quit date.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.4', 'spread': '5.9', 'groupId': 'BG000'}, {'value': '32.4', 'spread': '4.5', 'groupId': 'BG001'}, {'value': '31.9', 'spread': '5.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Greece', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-07', 'studyFirstSubmitDate': '2010-09-23', 'resultsFirstSubmitDate': '2013-01-23', 'studyFirstSubmitQcDate': '2010-09-25', 'lastUpdatePostDateStruct': {'date': '2013-04-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-04-07', 'studyFirstPostDateStruct': {'date': '2010-09-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-04-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Participants' Smoking Status", 'timeFrame': 'around the 32nd week of gestation.', 'description': "participants' smoking status was validated by urine cotinine and urine nicotine"}, {'measure': 'The Effectiveness of the Interventions According the Levels of Urine Cotinine Before and After Intervention.', 'timeFrame': 'At the baseline and at the 32nd week of gestation', 'description': 'The basic primary outcomes of the study present the levels of urine cotinine before and after intervention separately for each group according to the cut of point that is used for the separation of active from passive smoking ,when urine cotinine ≤80ng/ml: there is biochemically validated smoking cessation.'}], 'secondaryOutcomes': [{'measure': 'Birth Weight', 'timeFrame': 'After child birth', 'description': "Infants' birth weight was recorded."}, {'measure': 'Days of Prematurity of Birth', 'timeFrame': 'After child birth', 'description': 'Days of prematurity of birth were recorded'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pregnancy', 'Smoking cessation', 'Cognitive-Behavioural interventions'], 'conditions': ['Smoking Cessation']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Loukopoulou A N, Evangelopoulou V, Behrakis P K.Smoking and pregnancy. Pneumon 23(2):160-167,2010.'}, {'type': 'BACKGROUND', 'citation': 'Loukopoulou AN, Vasiliou MP, Behrakis PK. (2011) Interventions for smoking cessation during Pregnancy Pneumon, 24(1):381-391(Review).'}, {'pmid': '22145828', 'type': 'BACKGROUND', 'citation': 'Loukopoulou AN, Vardavas CI, Farmakides G, Rossolymos C, Chrelias C, Tzatzarakis MN, Tsatsakis A, Lymberi M, Connolly GN, Behrakis PK. Design and study protocol of the maternal smoking cessation during pregnancy study, (M-SCOPE). BMC Public Health. 2011 Dec 6;11:903. doi: 10.1186/1471-2458-11-903.'}, {'pmid': '33537575', 'type': 'DERIVED', 'citation': 'Loukopoulou AN, Vardavas CI, Farmakides G, Rosolymos C, Chrelias C, Tzatzarakis M, Tsatsakis A, Myridakis A, Lyberi M, Behrakis PK. Counselling for smoking cessation during pregnancy reduces tobacco-specific nitrosamine (NNAL) concentrations: A randomized controlled trial. Eur J Midwifery. 2018 Nov 14;2:14. doi: 10.18332/ejm/99546. eCollection 2018.'}], 'seeAlsoLinks': [{'url': 'http://www.nlm.nih.gov/medlineplus/quittingsmoking.html', 'label': 'MedlinePlus related topics: Pregnancy, Smoking Cessation'}]}, 'descriptionModule': {'briefSummary': 'The aim of this clinical trial is to test whether offering pregnant smokers a high intensity intervention for smoking cessation increases the rate of smoking cessation at the third trimester of pregnancy, compared to low intensity intervention for smoking cessation that is the usual care, control condition.', 'detailedDescription': "This is a randomized controlled trial that compares the efficacy of a proactive pregnancy-tailored high intensity intervention for smoking cessation, with a usual care low intensity intervention, that is the control condition.\n\nIntervention group participants will receive a high intensity intervention, which includes: 30 minutes of cognitive-behavioural intervention delivered by a trained health care professional through out the first 24 weeks of gestation and a self-help manual especially tailored for smoking cessation during pregnancy. Control group participants will receive 5 minutes of low intensity intervention.\n\nParticipants' smoking status will be biochemically validated with urine cotinine and nicotine both at the baseline and at the 32nd week of gestation, expired carbon monoxide (CO) will be measured only at the baseline. After childbirth the infants' birth weight, the premature birth and any other complications in pregnancy and childbirth will be recorded. No medication is going to be used."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Pregnant women\n* current cigarette smoker (smoked \\>5 cigarettes in the past 7 days)\n* 18 years old or older\n\nExclusion Criteria:\n\n* More than 24 weeks' gestation at study entry\n* No telephone access\n* Not planning to live in Athens for 1 year\n* Unable to read and speak Greek\n* Alcoholics\n* Use of drug substances\n* Depression"}, 'identificationModule': {'nctId': 'NCT01210118', 'briefTitle': 'Interventions of Smoking Cessation During Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'Hellenic Anticancer Society'}, 'officialTitle': 'The Effectiveness of High and Low Intensity Intervention for Smoking Cessation During Pregnancy', 'orgStudyIdInfo': {'id': 'PBAL001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High intensity intervention', 'description': 'Experimental group participants received a higher intensity intervention, which include: 30 minutes of individualized cognitive-behavioural counselling delivered by a trained health care professional and a self-help manual especially tailored for smoking cessation during pregnancy. Counseling was based at the "5 Αs" (Ask,Advise, Asses, Assist, Arrange). In addition to counselling, a self help manual especially tailored for smoking cessation during pregnancy for Greek women was provided.', 'interventionNames': ['Behavioral: Higher intensity intervention']}, {'type': 'OTHER', 'label': 'Low intensity intervention', 'description': 'Control group participants received a face to face low intensity intervention which lasted 5 minutes and included brief advice and the provision of a leaflet on smoking and pregnancy. This leaflet summarized the main effects of smoking during pregnancy and gave clear short messages for encouraging smoking cessation by setting up a quit date.', 'interventionNames': ['Behavioral: Low intensity intervention']}], 'interventions': [{'name': 'Low intensity intervention', 'type': 'BEHAVIORAL', 'description': 'Control group participants received a face to face low intensity intervention which lasted 5 minutes and included brief advice and the provision of a leaflet on smoking and pregnancy. This leaflet summarized the main effects of smoking during pregnancy and gave clear short messages for encouraging smoking cessation by setting up a quit date.', 'armGroupLabels': ['Low intensity intervention']}, {'name': 'Higher intensity intervention', 'type': 'BEHAVIORAL', 'otherNames': ['Experimental group'], 'description': 'Experimental group participants received a higher intensity intervention, which include: 30 minutes of individualized cognitive-behavioural counselling delivered by a trained health care professional and a self-help manual especially tailored for smoking cessation during pregnancy. Counseling was based at the "5 Αs" (Ask,Advise, Asses, Assist, Arrange). In addition to counselling, a self help manual especially tailored for smoking cessation during pregnancy for Greek women was provided.', 'armGroupLabels': ['High intensity intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Athens', 'state': 'Attica', 'country': 'Greece', 'facility': 'Peripheral General Hospital-Maternity Helena Venizelos', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '12462', 'city': 'Haidari', 'state': 'Attica', 'country': 'Greece', 'facility': 'Maternity Unit of ATTIKON University Hospital'}], 'overallOfficials': [{'name': 'Panagiotis K Behrakis, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'National and Kapodistrian University of Athens'}, {'name': 'Andriani N Loukopoulou, PhD pending', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National and Kapodistrian University of Athens'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hellenic Anticancer Society', 'class': 'OTHER'}, 'collaborators': [{'name': 'National and Kapodistrian University of Athens', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PROFESSOR OF NATIONAL AND KAPODISTRIAN UNIVERSITY OF ATHENS.', 'investigatorFullName': 'PANAGIOTIS BEHRAKIS', 'investigatorAffiliation': 'Hellenic Anticancer Society'}}}}