Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2025-12-27 @ 8:54 AM
Study NCT ID:
NCT06566703
Status:
RECRUITING
Last Update Posted:
2024-08-26
First Post:
2024-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Testing ANSOS for Efficacy in Multi-Tribal Urban Communities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020340', 'term': 'Tobacco Use Cessation'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 384}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2026-08-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-22', 'studyFirstSubmitDate': '2024-08-20', 'studyFirstSubmitQcDate': '2024-08-20', 'lastUpdatePostDateStruct': {'date': '2024-08-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with 7-day point prevalence abstinence', 'timeFrame': '6 months', 'description': '7-day point prevalence abstinence from smokeless tobacco product use'}], 'secondaryOutcomes': [{'measure': 'Number of participants with continuous abstinence', 'timeFrame': '6 months, 12 months', 'description': 'Continuous abstinence from smokeless tobacco product use'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['American Indian', 'smokeless tobacco cessation'], 'conditions': ['Smokeless Tobacco Cessation']}, 'descriptionModule': {'briefSummary': 'This is a wait-list control trial to test for efficacy of the All Nations Snuff Out Smokeless (ANSOS) recreational tobacco cessation program in multi-tribal American Indian (AI) communities. Participants randomized to the control arm are provided with a Healthy Living educational intervention while they wait for the program to encourage them to remain engaged with the study team during the six-month waiting period. Participants from the ANSOS arm are offered the Healthy Living educational intervention after they complete the 6-month outcome measures.', 'detailedDescription': 'All Nations Snuff Out Smokeless (ANSOS) is a culturally tailored, group-based quit smokeless tobacco (SLT) program for American Indian (AI) people. Intervention components are described below.\n\nGroup Support Sessions: The primary component of ANSOS are four group-based support sessions, led by an AI facilitator, conducted via Zoom. All group sessions begin with team building and discussion about things people are experiencing in their lives, both those related directly to recreational tobacco use and other things that help or hinder quit attempts. The first group session is devoted to forming a cohesive group and learning about individual journeys with tobacco. Additional group sessions focus on topics covered in the education curriculum.\n\nIndividual Telephone Counseling: After initial group sessions, facilitators call participants weekly to see how they are doing, discuss personal issues related to the quitting process, and to remind them of the next group.\n\nEducational Curriculum: The ANSOS curriculum includes 11 brochures, given throughout the program; it combines cessation information with cultural elements. Topics covered include substantial information about tobacco as a sacred plant for many, though not all, AI tribes, historical trauma, and medical/research mistrust issues, among other topics related to how to effectively quit using recreational tobacco products. Educational materials for this project will be given to participants electronically via pdf documents.\n\nHealthy Living is an educational program primarily designed to maintain the interest of participants in the control arm in continuing into the ANSOS program after their 6-month waiting period. It includes group-based educational discussion about healthy diet, exercise, and stress management, along with educational materials on these topics. Participants also receive individual discussion with program facilitators in between group sessions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 and over\n* Stable telephone number that can be used for the purpose of the study\n* Willing to be followed for 12 months and participate in study activities\n* Able to attend Zoom sessions\n* Current SLT user, at least once per day\n* Self-reported AI\n\nExclusion Criteria:\n\n* Cannot provide a stable phone number for 12 months for the purpose of the study\n* Unable to attend Zoom sessions'}, 'identificationModule': {'nctId': 'NCT06566703', 'briefTitle': 'Testing ANSOS for Efficacy in Multi-Tribal Urban Communities', 'organization': {'class': 'OTHER', 'fullName': 'Lehigh University'}, 'officialTitle': 'Testing All Nations Snuff Out Smokeless (ANSOS) for Efficacy in Multi-Tribal Urban Communities', 'orgStudyIdInfo': {'id': 'RSG-21-043-01-CPPB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'All Nation Snuff Out Smokeless', 'description': 'This is a culturally targeted smokeless tobacco cessation program developed for American Indian communities. It includes group sessions via Zoom, individual telephone counseling, and educational materials.', 'interventionNames': ['Behavioral: All Nations Snuff Out Smokeless', 'Behavioral: Healthy Living']}, {'type': 'EXPERIMENTAL', 'label': 'Wait List Control - Healthy Living', 'description': 'Participants randomized to this arm are provided with information about healthy living while they wait for their turn at the intervention arm. Participants learn about diet, exercise, and stress reduction. They receive the All Nations Snuff Out Smokeless intervention after a six-month waiting period.', 'interventionNames': ['Behavioral: All Nations Snuff Out Smokeless', 'Behavioral: Healthy Living']}], 'interventions': [{'name': 'All Nations Snuff Out Smokeless', 'type': 'BEHAVIORAL', 'description': 'All Nations Snuff Out Smokeless is a culturally tailored smokeless tobacco cessation program that incorporates group-based and individual counseling.', 'armGroupLabels': ['All Nation Snuff Out Smokeless', 'Wait List Control - Healthy Living']}, {'name': 'Healthy Living', 'type': 'BEHAVIORAL', 'description': 'Healthy Living is an educational program that provides information about diet, exercise, stress, and general health. It uses group-based and individual discussion, along with educational materials.', 'armGroupLabels': ['All Nation Snuff Out Smokeless', 'Wait List Control - Healthy Living']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18015', 'city': 'Bethlehem', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Christine M Daley, PhD', 'role': 'CONTACT', 'email': 'cmdaley@lehigh.edu', 'phone': '610-758-1878'}, {'name': 'Ryan Goeckner, PhD', 'role': 'CONTACT', 'email': 'rtgoeckner@gmail.com', 'phone': '610-758-3435'}], 'facility': 'Lehigh University', 'geoPoint': {'lat': 40.62593, 'lon': -75.37046}}], 'centralContacts': [{'name': 'Christine M Daley, PhD', 'role': 'CONTACT', 'email': 'cmdaley@lehigh.edu', 'phone': '610-758-1878'}, {'name': 'Ryan Goeckner, PhD', 'role': 'CONTACT', 'email': 'rtgoeckner@gmail.com', 'phone': '610-758-3435'}], 'overallOfficials': [{'name': 'Christine M Daley, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lehigh University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lehigh University', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Cancer Society, Inc.', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}