Ignite Creation Date:
2025-12-26 @ 2:41 PM
Ignite Modification Date:
2025-12-26 @ 2:41 PM
Study NCT ID:
NCT04414306
Status:
COMPLETED
Last Update Posted:
2024-01-25
First Post:
2020-06-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Screen to Save 2: Rural Cancer Screening Educational Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-10-16', 'releaseDate': '2025-10-02'}, {'resetDate': '2025-11-11', 'releaseDate': '2025-10-28'}], 'estimatedResultsFirstSubmitDate': '2025-10-02'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants whose initial engagement with the study via online study arms 2 and 3 will not know that they are being randomly assigned to one of two educational interventions: a video and website module about colorectal cancer screening or a video about lung cancer screening, and will not be told about the in-person educational arm. Participants in the in-person educational arm may be told that others are participating online as part of the study, but will not be told about he lung cancer screening video specifically.'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 382}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-23', 'studyFirstSubmitDate': '2020-06-01', 'studyFirstSubmitQcDate': '2020-06-01', 'lastUpdatePostDateStruct': {'date': '2024-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in knowledge related to colorectal cancer risk, prevention, and screening', 'timeFrame': 'pre-test administered immediately before educational intervention; post-test administered immediately after educational intervention; survey approximately 3 months after initial engagement in study', 'description': 'A pre-test and post-test are conducted with participants to assess any changes in knowledge related to key learning outcomes expected from the educational intervention (assessed via 14 true/false and multiple choice questions). Participants meeting eligibility criteria for inclusion in the three-month follow-up survey will also answer knowledge questions related to key learning outcomes in the three-month follow-up survey (assessed via 18 true/false and multiple choice questions).'}, {'measure': 'Change in colorectal cancer screening and other risk behavior intentions', 'timeFrame': 'pre-test administered immediately before educational intervention; post-test administered immediately after educational intervention', 'description': 'A pre-test and post-test are conducted to assess behavioral intention related to five prevention and screening behaviors (assessed via 5 questions on a 5-point Likert scale: strongly agree, agree, unsure, disagree, strongly disagree).'}, {'measure': 'Change in colorectal cancer screening behaviors', 'timeFrame': 'pre-test administered immediately before educational intervention; post-test administered immediately after educational intervention; approximately 3 months after initial engagement in study', 'description': 'Participants meeting the inclusion criteria for the three-month follow-up survey will answer three yes/no/decline to answer questions asked in the three-month follow-up survey regarding colorectal cancer screening behaviors. These questions are followed by a skip logic of additional multiple choice and free response questions to assess the nature of the changes (e.g. type of screening used).'}, {'measure': 'Change in non-screening cancer prevention behaviors', 'timeFrame': 'pre-test administered immediately before educational intervention; post-test administered immediately after educational intervention; approximately 3 months after initial engagement in study', 'description': 'Participants meeting the inclusion criteria for participation in the three-month follow-up survey will be asked two yes/no/decline to answer questions related to exercise/activity and diet since the time of initial participation in the study. These questions are followed by a skip logic of additional multiple choice questions to discern the direction of the change (e.g. increased/decreased physical activity; increased/decreased healthy eating habits).'}], 'secondaryOutcomes': [{'measure': 'Change in knowledge related to lung cancer risk, prevention, and screening', 'timeFrame': 'pre-test administered immediately before educational intervention; post-test administered immediately after educational intervention', 'description': 'A pre-test and post-test are conducted with participants to assess any changes in knowledge related to key learning outcomes expected from the educational intervention (assessed via 6 true/false questions).'}, {'measure': 'Reach to current and former cigarette smokers', 'timeFrame': 'survey administered immediately before educational intervention', 'description': 'Number and percentage of participants who indicate that they have quit smoking cigarettes within the last 15 years and the number and percentage of participants who indicate current tobacco use.'}, {'measure': 'Change in tobacco use frequency', 'timeFrame': 'survey administered immediately before educational intervention; approximately 3 months after initial participation in study', 'description': "Participants meeting the inclusion criteria for the three-month follow-up survey will answer a question about their current tobacco use (every day, some day, not at all, decline to answer) and responses will be compared to participants' answers to the same question administered approximately three months earlier before receiving the educational intervention"}, {'measure': 'Uptake of lung cancer screening behaviors', 'timeFrame': 'approximately 3 months after initial participation in study', 'description': 'Participants meeting the inclusion criteria for the three-month follow-up survey will answer two yes/no/decline to answer questions asked in the three-month follow-up survey regarding lung cancer screening behaviors since their initial participation in the study approximately three months earlier.'}, {'measure': 'Uptake of tobacco quitting behaviors', 'timeFrame': 'approximately 3 months after initial participation in study', 'description': 'Participants meeting the inclusion criteria for the three-month follow-up survey will answer four yes/no/decline to answer questions asked in the three-month follow-up survey regarding use of tobacco quitting services and quitting behavior since their initial participation in the study approximately three months earlier.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cancer', 'cancer screening', 'colorectal cancer', 'lung cancer', 'education', 'rural', 'lung cancer screening', 'tobacco'], 'conditions': ['Cancer', 'Colorectal Cancer', 'Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to help the Dartmouth Cancer Center and the National Cancer Institute understand how to educate people about cancer screening.', 'detailedDescription': "The Dartmouth Cancer Center's Community Outreach and Engagement Team will implement Screen to Save 2 in two formats-traditional outreach using in-person fairs and an online format. The education in both formats will be based on a set of key messages that cover information about colorectal cancer, including risk factors, prevention, screening recommendations, and screening options. Key messages provided by the National Cancer Institute will be tailored to the local context of NH and VT, including information about local options for getting screened for colorectal cancer. A third arm will receive education about lung cancer screening. This third arm will serve as the control arm for the first two arms (the arms receiving in-person or online colorectal cancer screening education) to assess study Aim 1. This third arm will also serve as an intervention arm for assessing Study Aim 2.\n\nUsing online or telephone surveys, some participants will be contacted approximately three months after their initial participation. Some of the participants contacted after three months will again be contacted another three months later (six months after initial participation). The three- and six-month surveys will assess knowledge, attitudes, beliefs, and behaviors related to cancer screening, including outcomes from cancer screening.\n\nThe primary aims of the study are as follows:\n\nAim 1: Implement and evaluate Screen to Save 2 outreach and educational activities to improve knowledge of colorectal cancer screening methods, to increase intent to get screened for colorectal cancer, and connect screening services to the target population.\n\nAim 1a: Conduct cancer screening fairs in Rural Urban Continuum Code (RUCC) 7-9 counties, using the Screen to Save 2 framework and materials and, where feasible, coordinate with local service providers to make colorectal cancer screening services available to event attendees.\n\nAim 1b: Utilize web-based module to conduct targeted outreach about colorectal cancer screening using the Screen to Save 2 framework and materials and refer them to locally-available screenings, healthcare provider systems, and/or healthcare coverage systems.\n\nThe secondary aim of the study is:\n\nAim 2: Evaluate online educational activities' ability to reach 45-74 year old current and former tobacco users from rural (RUCC 7-9) counties, increase lung cancer screening knowledge among that demographic, and encourage engagement with local tobacco treatment resources and lung cancer screening."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for study arms 1-4:\n\n* Resident of one of the RUCC 7-9 counties in New Hampshire or Vermont (Coos or Sullivan County, NH; Caledonia, Windsor, Windham, Orange, Orleans, Lamoille, or Essex County, VT) and\n* Age 45-74 at the time of enrollment in the study\n\nAdditional Inclusion Criteria for study arm 4:\n\n\\- Any New Hampshire or Vermont residents age 45-75\n\nExclusion Criteria:\n\n\\- Cognitive impairment preventing participation in informed consent process\n\nThree-Month Follow-Up Survey Inclusion Criteria:\n\nA participant will be eligible for inclusion in the three-month follow-up survey if the participant completed the pre-test, educational intervention, and post-test (in-person or through online submission) and at the time of initial participation:\n\n* Answered a colorectal cancer screening history question indicating that the participant has never received colorectal cancer screening OR does not know if he/she has received colorectal cancer screening previously OR\n* Answered a series of questions indicating that the participant received prior colorectal cancer screening but may be overdue for colorectal cancer screening based on the type of colorectal cancer screening last reported and screening guidelines for the frequency of re-screening.\n\nSix-Month Follow-Up Survey Inclusion Criteria:\n\nA participant will be eligible for inclusion in the six-month follow-up survey if the participant participated in the three-month-follow up survey and at that time reported that having:\n\n* A FIT/FOBT screening or Cologuard (stool) screening performed since the time of initial study participation, but having not received the results\n* An abnormal FIT/FOBT, or Cologuard (stool) screening since the time of initial study participation, but had not received a diagnostic colonoscopy\n* A colonoscopy since the time of initial study participation, but had not received the final results'}, 'identificationModule': {'nctId': 'NCT04414306', 'briefTitle': 'Screen to Save 2: Rural Cancer Screening Educational Intervention', 'organization': {'class': 'OTHER', 'fullName': 'Dartmouth-Hitchcock Medical Center'}, 'officialTitle': 'Screen to Save 2: Rural Cancer Screening Educational Intervention', 'orgStudyIdInfo': {'id': 'D20038'}, 'secondaryIdInfos': [{'id': 'P30CA023108-40S4', 'link': 'https://reporter.nih.gov/quickSearch/P30CA023108-40S4', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Arm 1', 'description': 'Attendees at in-person events (e.g. health fairs) who meet eligibility criteria will be able to enroll and participate in-person, with some participating in online or telephone survey follow-up.', 'interventionNames': ['Other: In-person cancer screening education']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Arm 2', 'description': 'People with social medial accounts (e.g. Facebook) will receive a message about the study (e.g. via an age and geospatially targeted Facebook ad) and have the option to enroll in the study if meeting eligibility criteria, with some participating in online or telephone follow-up.', 'interventionNames': ['Other: Online educational video and website module']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Arm 3', 'description': 'People with social medial accounts (e.g. Facebook) will receive a message about the study (e.g. via an age and geospatially targeted Facebook ad) and have the option to enroll in the study if meeting eligibility criteria, with some participating in online or telephone follow-up. This arms will serve as an experimental arm for assessing study aim 2 and as a control arm for study aim 1.', 'interventionNames': ['Other: Online educational video']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Arm 4', 'description': "Patients identified by one or more healthcare systems to be due or overdue for colorectal cancer screening will be informed by their healthcare provider or healthcare system (e.g. via the healthcare system's patient portal) that they are due for screening and will be informed how to schedule an colorectal cancer screening related appointment (e.g. discussion with primary care provider about colorectal cancer screening options) along with the option to receive education about colorectal cancer screening. Patients who are interested in receiving education may view the education with or without participating in the research study. Patients who elect to be study participants will participate in consenting, eligibility screening, pre-test, post-test, and possible three- and six-month using a parallel structure to study arms two and three.", 'interventionNames': ['Other: Message from healthcare system and online educational video and website module']}], 'interventions': [{'name': 'In-person cancer screening education', 'type': 'OTHER', 'description': 'Participants will receive verbal instruction covering the key messages, including risk factors, prevention, screening recommendations, and screening options pertaining to colorectal cancer. These in-person programs will take place in a variety of settings such as community-based organizations (e.g., community businesses, libraries, faith-based organizations, senior centers), fairs and community events, and clinical centers (e.g., health centers, local hospitals). Depending on the setting, education will be facilitated with one or more of the following educational tools: inflatable colon exhibit, PowerPoint presentation, flip chart/flip book, written materials/handouts, and displays. Data will be collected via pre- and post-tests. Some participants will be asked to participate in three and/or six-month follow-up surveys administered online or by telephone.', 'armGroupLabels': ['Experimental Arm 1']}, {'name': 'Online educational video and website module', 'type': 'OTHER', 'description': 'Participants will receive online education via a video and website. Key messages will include information on risk factors, prevention, screening recommendations, and screening options pertaining to colorectal cancer. Some participants will be asked to participate in three and/or six-month follow-up surveys administered online or by telephone.', 'armGroupLabels': ['Experimental Arm 2']}, {'name': 'Online educational video', 'type': 'OTHER', 'description': 'Participants will receive online education via a video and website about lung cancer screening. Some participants will be asked to participate in three and/or six-month follow-up surveys administered online or by telephone.', 'armGroupLabels': ['Experimental Arm 3']}, {'name': 'Message from healthcare system and online educational video and website module', 'type': 'OTHER', 'description': 'Patients at one or more healthcare systems will receive a message from their healthcare provider or healthcare system indicating that they are due or overdue for colorectal cancer screening and receive information on how to schedule a related care (e.g. appointment with primary care provider to discuss screening options) and have the option of receiving education via on online video and website module with or without research study participation. Only recipients of this information who opt into the study through a consenting process will be considered study participants. Key messages will include information on risk factors, prevention, screening recommendations, and screening options pertaining to colorectal cancer. Some participants will be asked to participate in three and/or six-month follow-up surveys administered online or by telephone.', 'armGroupLabels': ['Experimental Arm 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth Cancer Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}], 'overallOfficials': [{'name': 'Judith Rees, BM, BCh, MPH, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Geisel School of Medicine, Dartmouth College'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dartmouth-Hitchcock Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'Dartmouth College', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Department of Epidemiology, Geisel School of Medicine, Dartmouth College Associate Director for Community Outreach and Engagement, Norris Cotton Cancer Center', 'investigatorFullName': 'Judith R. Rees', 'investigatorAffiliation': 'Trustees of Dartmouth College'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-10-02', 'type': 'RELEASE'}, {'date': '2025-10-16', 'type': 'RESET'}, {'date': '2025-10-28', 'type': 'RELEASE'}, {'date': '2025-11-11', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Judith R. Rees, Associate Professor, Department of Epidemiology, Geisel School of Medicine, Dartmouth College Associate Director for Community Outreach and Engagement, Norris Cotton Cancer Center, Trustees of Dartmouth College'}}}}