Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 10:46 PM
Study NCT ID:
NCT07210567
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-07
First Post:
2025-09-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mindfulness-based Ecological Momentary Intervention for Smoking Cessation Among Cancer Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064866', 'term': 'Mindfulness'}], 'ancestors': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-29', 'studyFirstSubmitDate': '2025-09-17', 'studyFirstSubmitQcDate': '2025-09-29', 'lastUpdatePostDateStruct': {'date': '2025-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'System Usablity Scale', 'timeFrame': 'End of Treatment at 4 Weeks', 'description': 'Perceived usability and learnability of the app will be measured on a 5-point scale (1=strongly disagree; 5=strongly agree).'}, {'measure': 'Client Satisfaction Questionnaire', 'timeFrame': 'End of Treatment at 4 Weeks', 'description': 'Perceived satisfaction with the treatment will be assessed on a 4-point scale (1=very dissatisfied; 4=very satisfied).'}, {'measure': 'Percentage of Participants That Completed Questionnaires', 'timeFrame': '3-month follow-up', 'description': 'Completion of follow-up assessment will be calculated.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['quit smoking', 'cancer survivors'], 'conditions': ['Smoking Cessation']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to develop a new quit-smoking treatment among individuals with a cancer diagnosis using a smartphone app.', 'detailedDescription': 'The study aims to test the feasibility and acceptability of the smartphone app we developed in conjunction with face-to-face brief cessation counseling and nicotine replacement therapy in a two-arm randomized controlled trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥18 years old\n* smoked ≥1 cigarette per day (even one or two puffs) within the past 30 days\n* having been diagnosed with cancer\n* being motivated to quit in the next 30 days\n* having a valid home address and functioning phone number\n* being able to read, write, and speak English\n* having a smartphone that allows installation of the app\n* willingness to download the app\n\nExclusion Criteria:\n\n* being enrolled in a smoking cessation program\n* current use of smoking cessation medications\n* evidence of current psychosis\n* current/planning pregnancy or lactation'}, 'identificationModule': {'nctId': 'NCT07210567', 'briefTitle': 'Mindfulness-based Ecological Momentary Intervention for Smoking Cessation Among Cancer Survivors', 'organization': {'class': 'OTHER', 'fullName': 'Rutgers, The State University of New Jersey'}, 'officialTitle': 'Mindfulness-based Ecological Momentary Intervention for Smoking Cessation Among Cancer Survivors', 'orgStudyIdInfo': {'id': 'Pro2024002019'}, 'secondaryIdInfos': [{'id': 'R00CA271040', 'link': 'https://reporter.nih.gov/quickSearch/R00CA271040', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mindfulness', 'description': 'Participants will receive brief counseling, nicotine replacement therapy, and intervention content delivered via the app.', 'interventionNames': ['Behavioral: Mindfulness']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Quitline', 'description': 'Participants will be referred to Quitline to receive standard care for smoking cessation.', 'interventionNames': ['Behavioral: Quitline']}], 'interventions': [{'name': 'Mindfulness', 'type': 'BEHAVIORAL', 'description': 'Participants will complete 4 counseling sessions (30 minutes), download and use a smartphone app for 4 weeks, complete 4 online surveys (baseline, quit date, end of treatment, and 3-month follow-up), and a brief phone call at the end of treatment to provide feedback. Participants will use the app every day to complete daily diaries and ecological momentary assessments (EMAs), receive brief mindful skills, and practice formal mindfulness meditations (5-30 minutes). Participants will also be provided with nicotine patches.', 'armGroupLabels': ['Mindfulness']}, {'name': 'Quitline', 'type': 'BEHAVIORAL', 'description': 'Participants will be referred to Quitline to receive standard care smoking cessation treatment, including counseling and nicotine patches. Participants will complete 4 online surveys (baseline, quit date, end of treatment, and 3-month follow-up) and a brief phone call at the end of treatment to provide feedback. Participants will use the app every day to complete daily diaries.', 'armGroupLabels': ['Quitline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Institute for Nicotine & Tobacco Studies', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}], 'centralContacts': [{'name': 'Rutgers IRB/Human Research Protection Program', 'role': 'CONTACT', 'email': 'irboffice@research.rutgers.edu', 'phone': '9739723608'}], 'overallOfficials': [{'name': 'Min-Jeong Yang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rutgers, The State University of New Jersey'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rutgers, The State University of New Jersey', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Min-Jeong Yang, Ph.D.', 'investigatorAffiliation': 'Rutgers, The State University of New Jersey'}}}}