Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:34 AM
Study NCT ID:
NCT04555902
Status:
COMPLETED
Last Update Posted:
2021-11-15
First Post:
2020-09-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Mailers Promoting Mammogram Screening
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D003142', 'term': 'Communication'}, {'id': 'D040242', 'term': 'Risk Reduction Behavior'}, {'id': 'D001519', 'term': 'Behavior'}], '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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-06-11', 'size': 96157, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-06-18T08:56', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'Participants and providers are not aware of the different mailer versions.'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': '1 x 3 design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1342}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-10-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-12', 'studyFirstSubmitDate': '2020-09-04', 'studyFirstSubmitQcDate': '2020-09-14', 'lastUpdatePostDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Mammogram Completion at 12 months (2019)', 'timeFrame': '12 months from 2019 intervention start date', 'description': 'Binary variable indicating whether a mammogram was completed to be used for exploratory pre-post comparisons'}, {'measure': 'Primary Care Provider Visits at 12 months (2019)', 'timeFrame': '12 months from 2019 intervention start date', 'description': 'Number of visits to be used for exploratory pre-post comparisons (proxy for increased preventative health care)'}, {'measure': 'Breast Cancer Diagnosis at 12 months (2019)', 'timeFrame': '12 months from 2019 intervention start date', 'description': 'Binary variable indicating whether the woman was diagnosed with breast cancer'}, {'measure': 'Emergency Department Visits at 12 months (2019)', 'timeFrame': '12 months from 2019 intervention start date', 'description': 'Number of Emergency Department Visits (proxy for increased costly utilization of health system resources)'}], 'primaryOutcomes': [{'measure': 'Mammogram Completion at 6 months (2020)', 'timeFrame': '6 months from intervention start date', 'description': 'Binary variable indicating whether a mammogram was completed'}], 'secondaryOutcomes': [{'measure': 'Mammogram Completion at 12 months (2020)', 'timeFrame': '12 months from intervention start date', 'description': 'Binary variable indicating whether a mammogram was completed (a longer time frame allows for late responses)'}, {'measure': 'Primary Care Provider Visits at 6 months (2020)', 'timeFrame': '6 months from intervention start date', 'description': 'Number of visits (proxy for increased preventative health care)'}, {'measure': 'Primary Care Provider Visits at 12 months (2020)', 'timeFrame': '12 months from intervention start date', 'description': 'Number of visits (proxy for increased preventative health care)'}, {'measure': 'Obstetrician-Gynecologist Visits at 6 months (2020)', 'timeFrame': '6 months from intervention start date', 'description': 'Number of visits (proxy for increased preventative health care)'}, {'measure': 'Obstetrician-Gynecologist Visits at 12 months (2020)', 'timeFrame': '12 months from intervention start date', 'description': 'Number of visits (proxy for increased preventative health care)'}, {'measure': 'Breast Cancer Diagnosis at 6 months (2020)', 'timeFrame': '6 months from intervention start date', 'description': 'Binary variable indicating whether the recipient was diagnosed with breast cancer'}, {'measure': 'Breast Cancer Diagnosis at 12 months (2020)', 'timeFrame': '12 months from intervention start date', 'description': 'Binary variable indicating whether the recipient was diagnosed with breast cancer'}, {'measure': 'Emergency Department Visits at 6 months (2020)', 'timeFrame': '6 months from intervention start date', 'description': 'Number of Emergency Department Visits (proxy for increased costly utilization of health system resources)'}, {'measure': 'Emergency Department Visits at 12 months (2020)', 'timeFrame': '12 months from intervention start date', 'description': 'Number of Emergency Department Visits (proxy for increased costly utilization of health system resources)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mass Screening', 'Communication', 'Mammography', 'Risk Reduction Behavior', 'Economics, Behavioral', 'Psychology', 'Loss Frame', 'Fear Appeals', 'Reciprocity'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'In this evaluation, 3 different versions of mailers promoting annual mammograms are being sent to women on the month of their 50th and 64th birthdays. The researchers hypothesize that the use of behavioral nudges in the mailers should lead to increased uptake in mammogram screening.', 'detailedDescription': 'Mammogram screening for women, starting at age 50, can significantly reduce the risk of complications due to breast cancer. As part of an existing outreach campaign, the health system mails a postcard and small gift (pink socks) to women on the month of their 50th and 64th birthdays to promote annual mammogram screening.\n\nThe researchers are evaluating two new versions of the mailers against a standard mailer to see which version leads to greater uptake in mammograms. The new mailers have content that applies behavioral nudge theory - specifically, loss frames and fear appeals - to encourage taking action. One of the two new versions does not include the small gift, to test whether its inclusion or exclusion has any effect on mammogram screening.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female Geisinger Health Plan members turning 50 and 64 in that month\n* For the 2020 campaign, birthdays from June 2020 (as opposed to August 2020) will be included due to a temporary suspension of the outreach program due to the COVID-19 pandemic since June\n* For the pre-post examination of the 2019 campaign, all months in that year will be included\n\nExclusion Criteria:\n\n\\- Members who are on the do not contact list at Geisinger Health Plan'}, 'identificationModule': {'nctId': 'NCT04555902', 'briefTitle': 'Evaluation of Mailers Promoting Mammogram Screening', 'organization': {'class': 'OTHER', 'fullName': 'Geisinger Clinic'}, 'officialTitle': 'Evaluation of Postcard Mailers Enhanced With Behavioral Nudges to Promote Mammogram Screening', 'orgStudyIdInfo': {'id': '2020-0761'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Mailer and Small Gift', 'description': 'A postcard encourages mammograms and includes a small gift.', 'interventionNames': ['Behavioral: Postcard', 'Behavioral: Small Gift']}, {'type': 'EXPERIMENTAL', 'label': 'Mailer with Loss Frame, Risks, and Small Gift', 'description': 'The postcard is enhanced with language that further emphasizes the risks but also clearly describes how early detection with a test can reduce those risks; a small gift is included.', 'interventionNames': ['Behavioral: Postcard', 'Behavioral: Small Gift', 'Behavioral: Loss Frame and Fear Appeals']}, {'type': 'EXPERIMENTAL', 'label': 'Mailer with Loss Frame, Risks, and No Gift', 'description': 'The postcard is enhanced with language that further emphasizes the risks but also clearly describes how early detection with a test can reduce those risks; the small gift is not included.', 'interventionNames': ['Behavioral: Postcard', 'Behavioral: Loss Frame and Fear Appeals']}], 'interventions': [{'name': 'Postcard', 'type': 'BEHAVIORAL', 'description': 'The postcard includes appeals to get annual mammograms and provides information for ordering a mammogram.', 'armGroupLabels': ['Mailer with Loss Frame, Risks, and No Gift', 'Mailer with Loss Frame, Risks, and Small Gift', 'Standard Mailer and Small Gift']}, {'name': 'Small Gift', 'type': 'BEHAVIORAL', 'description': 'Pink socks are included in the mailer. The gift increases salience of the mailer and it potentially promotes reciprocation from the recipient in the form of ordering a mammogram.', 'armGroupLabels': ['Mailer with Loss Frame, Risks, and Small Gift', 'Standard Mailer and Small Gift']}, {'name': 'Loss Frame and Fear Appeals', 'type': 'BEHAVIORAL', 'description': 'The postcard is enhanced with language that frames the situation in terms of losses. It also uses fear appeals by stating the risks of breast cancer, while also stating that a mammogram screening is an accessible way to address those risks.', 'armGroupLabels': ['Mailer with Loss Frame, Risks, and No Gift', 'Mailer with Loss Frame, Risks, and Small Gift']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17822', 'city': 'Danville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Geisinger', 'geoPoint': {'lat': 40.96342, 'lon': -76.61273}}], 'overallOfficials': [{'name': 'Amir Goren, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Geisinger Clinic'}]}, 'ipdSharingStatementModule': {'url': 'http://osf.io', 'infoTypes': ['STUDY_PROTOCOL', 'ANALYTIC_CODE'], 'timeFrame': 'The data will become available after publication of study results in a scientific journal and will be available as long as the Open Science Framework hosts the data.', 'ipdSharing': 'YES', 'description': 'Data with no personally identifiable information will be made available to other researchers on the Open Science Framework for transparency. This will include the essential data and code needed to replicate the analysis that yielded reported findings. The PI did not examine or analyze any data from this study prior to this registration.', 'accessCriteria': 'The data on the Open Science Framework will be open to anyone requesting that information.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Geisinger Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Program Director, Behavioral Insights Team', 'investigatorFullName': 'Amir Goren', 'investigatorAffiliation': 'Geisinger Clinic'}}}}