Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:30 PM
Study NCT ID:
NCT03519451
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-08
First Post:
2018-04-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of a Smartphone Mobile Application (App) to Enhance Smoking Cessation Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D014029', 'term': 'Tobacco Use Disorder'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-07', 'studyFirstSubmitDate': '2018-04-26', 'studyFirstSubmitQcDate': '2018-04-26', 'lastUpdatePostDateStruct': {'date': '2025-10-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'KickAsh group compliance with mood rating', 'timeFrame': 'Up to 8 weeks from start of study', 'description': 'KickAsh group compliance with mood rating determined by questionnaires, phone calls, and interview.'}, {'measure': 'KickAsh group change in activity level', 'timeFrame': 'Up to 8 weeks from start of study', 'description': 'KickAsh group change in activity level determined by questionnaires, phone calls, and interview.'}, {'measure': 'KickAsh group user satisfaction', 'timeFrame': 'Up to 8 weeks from start of study', 'description': 'KickAsh group user satisfaction determined by questionnaires, phone calls, and interview.'}, {'measure': 'Evidence of increased activity level in KickAsh and Breathe2Relax groups', 'timeFrame': 'Up to 8 weeks from start of study', 'description': 'Increase in activity level determined by questionnaires, phone calls, and interview.'}, {'measure': 'Evidence of improved mood in KickAsh and Breathe2Relax groups', 'timeFrame': 'Up to 8 weeks from start of study', 'description': 'Evidence of improved mood determined by questionnaires, phone calls, and interview.'}, {'measure': 'Evidence of greater smoking abstinence in KickAsh and Breathe2Relax groups', 'timeFrame': 'Up to 8 weeks from start of study', 'description': 'Evidence of greater smoking abstinence determined by questionnaires, phone calls, and interview.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Depression', 'Tobacco Use Disorder', 'Current Every Day Smoker']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'MD Anderson Cancer Center Website'}]}, 'descriptionModule': {'briefSummary': 'This trial studies how well smartphone mobile applications work in enhancing smoking cessation treatment in current smokers. Smartphone mobile applications may help current smokers quit smoking.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To test the acceptability and preliminary efficacy of a smartphone health application (app), Kick Ash, which will incorporate brief behavioral activation versus (vs.) a relaxation app, Breathe2Relax in a small randomized controlled trial of smokers with elevated depressive symptoms.\n\nOUTLINE: Participants are randomized to 1 of 2 groups.\n\nGROUP I: Participants receive KickAsh smartphone mobile application designed to help the learning of relaxation skills over 8 weeks.\n\nGROUP II: Participants receive Breathe2Relax smartphone mobile application designed to help improve mood and increase level of enjoyable activities over 8 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* MD Anderson patient between the ages of 18 to 65\n* Current smoker (i.e., at least 1 cigarette or e-cigarette per day)\n* Smoking for at least one year\n* Willing to set a quit date in the next 30 days\n* Not engaged in smoking cessation treatment other than the MDACC Tobacco Treatment Program\n* Currently elevated depressive symptoms or a history of elevated depressive symptoms; (PHQ 2 = or \\> 1); current or past\n* English speaking and ability to read and comprehend English\n* Currently own an iOS mobile phone or tablet (iPhone; iPad) using iOS 9.0 or later and reports regular use (at least weekly) of at least 1 iOS app\n\nExclusion Criteria:\n\n* Any medical or psychiatric condition, illness, disorder, or concomitant medication that could compromise participant safety or treatment, as determined by the Principal Investigator or Collaborator\n* Subject considered by the investigator an unsuitable candidate for receipt of a smoking cessation treatment or unstable to be followed up throughout the entire duration of the study'}, 'identificationModule': {'nctId': 'NCT03519451', 'briefTitle': 'Use of a Smartphone Mobile Application (App) to Enhance Smoking Cessation Treatment', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Use of a Smartphone Mobile Application (App) to Enhance Smoking Cessation Treatment - A Pilot Study', 'orgStudyIdInfo': {'id': '2017-0720'}, 'secondaryIdInfos': [{'id': 'NCI-2018-01158', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '2017-0720', 'type': 'OTHER', 'domain': 'M D Anderson Cancer Center'}, {'id': 'R43CA206682', 'link': 'https://reporter.nih.gov/quickSearch/R43CA206682', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group I (KickAsh smartphone mobile application)', 'description': 'Participants receive KickAsh smartphone mobile application designed to help the learning of relaxation skills over 8 weeks.', 'interventionNames': ['Other: Internet-Based Intervention', 'Other: Questionnaire Administration']}, {'type': 'EXPERIMENTAL', 'label': 'Group II (Breathe2Relax smartphone mobile application)', 'description': 'Participants receive Breathe2Relax smartphone mobile application designed to help improve mood and increase level of enjoyable activities over 8 weeks.', 'interventionNames': ['Other: Internet-Based Intervention', 'Other: Questionnaire Administration']}], 'interventions': [{'name': 'Internet-Based Intervention', 'type': 'OTHER', 'description': 'Given KickAsh smartphone mobile application', 'armGroupLabels': ['Group I (KickAsh smartphone mobile application)']}, {'name': 'Internet-Based Intervention', 'type': 'OTHER', 'description': 'Given Breathe2Relax smartphone mobile application', 'armGroupLabels': ['Group II (Breathe2Relax smartphone mobile application)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Group I (KickAsh smartphone mobile application)', 'Group II (Breathe2Relax smartphone mobile application)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'M D Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Jennifer A Minnix', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}