Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2025-12-30 @ 1:11 AM
Study NCT ID:
NCT03046004
Status:
COMPLETED
Last Update Posted:
2021-04-06
First Post:
2017-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Information About the Benefits and Harms of Mammography on Women's Decision Making
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003661', 'term': 'Decision Support Techniques'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2018-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-02', 'studyFirstSubmitDate': '2017-02-04', 'studyFirstSubmitQcDate': '2017-02-04', 'lastUpdatePostDateStruct': {'date': '2021-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Informed choice', 'timeFrame': 'Two weeks after the intervention', 'description': 'The primary outcome is informed choice about breast screening (adequate knowledge, and consistency between attitudes and intentions). See Hersch 2015.'}], 'secondaryOutcomes': [{'measure': 'Breast screening attitudes', 'timeFrame': 'Two weeks after the intervention', 'description': 'According to Hersch 2015'}, {'measure': 'Breast screening intention', 'timeFrame': 'Two weeks after the intervention and after being invited to be screened', 'description': 'According to Hersch 2015'}, {'measure': 'Decisional conflict', 'timeFrame': 'Two weeks after the intervention', 'description': 'According to Hersch 2015'}, {'measure': 'Confidence in the decision made', 'timeFrame': 'Two weeks after the intervention', 'description': 'According to Hersch 2015'}, {'measure': 'Anxiety about screening participation', 'timeFrame': 'Two weeks after the intervention', 'description': 'According to Hersch 2015'}, {'measure': 'Worry about breast cancer', 'timeFrame': 'Two weeks after the intervention', 'description': 'According to Hersch 2015'}, {'measure': 'Anticipated regret', 'timeFrame': 'Two weeks after the intervention', 'description': 'According to Hersch 2015'}, {'measure': 'Time perspective', 'timeFrame': 'Two weeks after the intervention', 'description': 'According to Hersch 2015'}, {'measure': 'Perceived importance of benefit/harms of screening', 'timeFrame': 'Two weeks after the intervention', 'description': 'According to Hersch 2015'}, {'measure': 'Perceived risk of breast cancer', 'timeFrame': 'Two weeks after the intervention', 'description': 'According to Hersch 2015'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['breast cancer', 'screening', 'decision aid', 'informed choice', 'decisional conflict'], 'conditions': ['Breast Cancer Screening']}, 'referencesModule': {'references': [{'pmid': '28145105', 'type': 'BACKGROUND', 'citation': 'Toledo-Chavarri A, Rue M, Codern-Bove N, Carles-Lavila M, Perestelo-Perez L, Perez-Lacasta MJ, Feijoo-Cid M; InforMa Study Group. A qualitative study on a decision aid for breast cancer screening: Views from women and health professionals. Eur J Cancer Care (Engl). 2017 May;26(3). doi: 10.1111/ecc.12660. Epub 2017 Feb 1.'}, {'pmid': '30913217', 'type': 'BACKGROUND', 'citation': "Perez-Lacasta MJ, Martinez-Alonso M, Garcia M, Sala M, Perestelo-Perez L, Vidal C, Codern-Bove N, Feijoo-Cid M, Toledo-Chavarri A, Cardona A, Pons A, Carles-Lavila M, Rue M; with the InforMa Group. Effect of information about the benefits and harms of mammography on women's decision making: The InforMa randomised controlled trial. PLoS One. 2019 Mar 26;14(3):e0214057. doi: 10.1371/journal.pone.0214057. eCollection 2019."}, {'pmid': '32173050', 'type': 'BACKGROUND', 'citation': 'Pons-Rodriguez A, Martinez-Alonso M, Perestelo-Perez L, Garcia M, Sala M, Rue M; en nombre del grupo InforMa; El grupo InforMa esta formado por. [Informed choice in breast cancer screening: the role of education]. Gac Sanit. 2021 May-Jun;35(3):243-249. doi: 10.1016/j.gaceta.2020.01.002. Epub 2020 Mar 12. Spanish.'}, {'pmid': '25701273', 'type': 'RESULT', 'citation': 'Hersch J, Barratt A, Jansen J, Irwig L, McGeechan K, Jacklyn G, Thornton H, Dhillon H, Houssami N, McCaffery K. Use of a decision aid including information on overdetection to support informed choice about breast cancer screening: a randomised controlled trial. Lancet. 2015 Apr 25;385(9978):1642-52. doi: 10.1016/S0140-6736(15)60123-4. Epub 2015 Feb 18.'}, {'pmid': '28899412', 'type': 'DERIVED', 'citation': "Carles M, Martinez-Alonso M, Pons A, Perez-Lacasta MJ, Perestelo-Perez L, Sala M, Vidal C, Garcia M, Toledo-Chavarri A, Codern N, Feijoo-Cid M, Romero A, Pla R, Soler-Gonzalez J, Castells X, Rue M; InforMa Group. The effect of information about the benefits and harms of mammography on women's decision-making: study protocol for a randomized controlled trial. Trials. 2017 Sep 12;18(1):426. doi: 10.1186/s13063-017-2161-7."}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess the effect of receiving information about the benefits and harms of mammography screening on informed choice, decisional conflict, intention to participate in the Early Detection of Breast Cancer Program (EDBCP), and satisfaction. The primary outcome is informed choice about breast screening (adequate knowledge, and consistency between attitudes and intentions). The sample of participants is composed by 400 women from Catalonia and the Canary Islands (Spain) who will receive their first invitation to participate in the EDBCP of the Public Health Service in a period of 2-4 months.', 'detailedDescription': 'The selected women will receive a letter of invitation with information about the study. In the following 1-2 weeks they will receive a phone call to confirm that they have received the mailed letter and to assess the inclusion criteria. If they agree to participate in the study, they will be asked for informed consent. All the participants will receive a first questionnaire, the pre-intervention survey (10-15 minutes), via web or regular mail. Trained interviewers will collect the responses by phone for women who prefer this method. Once the pre-intervention survey is completed, women will receive the leaflet (intervention or control) via regular mail. Two weeks later, the participants will be contacted again to collect the post-intervention survey (15-20 minutes), via web or by phone. Participation in the mammographic exams of the EDBCP will be collected in the three-month period following the corresponding invitation letter.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '49 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Women aged 49-50 who - in 2-4 months - will be invited to participate for the first time in the EDBCP of the Institut Hospital del Mar d'Investigacions Mèdiques (IMIM, Barcelona), ICO-Hospitalet (Hospitalet de Llobregat), Lleida Health Region, and the Canary Islands.\n* Women with low health literacy will be included\n\nExclusion Criteria:\n\n* Previous history of breast cancer\n* Difficulty speaking Spanish or Catalan\n* Cognitive impairment to understand or complete the materials based on the interviewer judgment"}, 'identificationModule': {'nctId': 'NCT03046004', 'acronym': 'InforMa', 'briefTitle': "Effect of Information About the Benefits and Harms of Mammography on Women's Decision Making", 'organization': {'class': 'OTHER', 'fullName': 'Institut de Recerca Biomèdica de Lleida'}, 'officialTitle': "The Effect of Receiving Information About the Benefits and Harms of Mammography Screening on Women's Decision Making", 'orgStudyIdInfo': {'id': 'PI14/00113'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Decision aid', 'description': 'Women in the intervention arm will receive a leaflet with detailed information on the benefits (breast cancer mortality reduction, less intensive treatments) and harms (false positive results and overdiagnosis).', 'interventionNames': ['Other: Decision aid for breast cancer screening']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Women in the control arm will receive a standard leaflet that does not mention harms and recommends accepting the invitation to participate in the biennial exams of the EDBCP.', 'interventionNames': ['Other: Standard leaflet']}], 'interventions': [{'name': 'Decision aid for breast cancer screening', 'type': 'OTHER', 'description': 'Women in the intervention arm will receive a leaflet with detailed information on the benefits (breast cancer mortality reduction, less intensive treatments) and harms (false positive results and overdiagnosis).', 'armGroupLabels': ['Decision aid']}, {'name': 'Standard leaflet', 'type': 'OTHER', 'description': 'Women in the control arm will receive a standard leaflet that does not mention harms and recommends accepting the invitation to participate in the biennial exams of the EDBCP.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25198', 'city': 'Lleida', 'country': 'Spain', 'facility': 'Lleida Biomedical Research Institute (IRBLLEIDA)', 'geoPoint': {'lat': 41.61674, 'lon': 0.62218}}], 'overallOfficials': [{'name': 'Montserrat Rué, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitat de Lleida-IRBLLEIDA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut de Recerca Biomèdica de Lleida', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital del Mar', 'class': 'OTHER'}, {'name': 'Canary Islands Health Service', 'class': 'UNKNOWN'}, {'name': "Institut Català d'Oncologia", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Montserrat Rue', 'investigatorAffiliation': 'Institut de Recerca Biomèdica de Lleida'}}}}