Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
Study NCT ID:
NCT07166120
Status:
RECRUITING
Last Update Posted:
2025-10-30
First Post:
2025-09-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Precision Treatment to Promote Smoking Cessation and Survival in Oncology Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}, {'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomization occurs at the clinician level. For pragmatic concerns, the investigators expect to recruit from multiple clinics and cluster randomization of clinicians will be stratified by clinics to minimize the clinic effect. Given the stratified randomization by clinic and the possibility of an unequal number of physicians across the 2 arms (i.e., we may not have exactly 8 in each arm), the investigators aim to recruit 8 clinicians per arm.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 112}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-28', 'studyFirstSubmitDate': '2025-09-02', 'studyFirstSubmitQcDate': '2025-09-02', 'lastUpdatePostDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient receipt of tobacco treatment medication for smoking cessation', 'timeFrame': '6 months post-intervention', 'description': 'This will be quantified by the proportion of enrolled patients who receive cessation medication.'}, {'measure': 'Patient use of cessation medication', 'timeFrame': '6 months post-intervention', 'description': 'This will be quantified by the proportion of patients taking any cessation medication from time of enrollment through 6 months post-intervention.'}, {'measure': 'Patient smoking abstinence', 'timeFrame': '6 months post-intervention', 'description': 'This will be quantified by the proportion of patients who smoke with bioverified point-prevalent abstinence at 6 months.'}], 'secondaryOutcomes': [{'measure': 'Patient quality of life', 'timeFrame': '6 and 12 months post-intervention', 'description': 'Quality of life measure will be measured using European Organization for Research and Treatment of Cancer Quality of life Questionnaire-Core 30 (EORTC QLQ-C30). All of the scales and single-item range in score from 0-100. A high scale score represents a higher response level. Thus, a high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents high quality of life, but a high score for a symptom scale / item represents a high level of symptomatology/problems.'}, {'measure': 'Patient survival', 'timeFrame': '6 and 12 months post-intervention', 'description': 'Probability of survival from the start of intervention'}, {'measure': 'Patient receipt of recommended tobacco treatment', 'timeFrame': '6 months post-intervention', 'description': 'This will be quantified by the proportion of enrolled patients who received recommended cessation medication.'}, {'measure': 'Patient medication adherence', 'timeFrame': '6 months post-intervention', 'description': 'This will be quantified by the proportion of medication taken among medication prescribed.'}, {'measure': 'Patient smoking abstinence among treated', 'timeFrame': '6 months post-intervention', 'description': 'This will be quantified by the proportion of smokers with bioverified point-prevalence abstinence among those receiving cessation medication.'}, {'measure': 'Abstinence Outcomes Across Multiple Time Points', 'timeFrame': 'From intervention through 12 months post-intervention', 'description': 'The outcome measures abstinence (self-reported no smoking (not even a puff of a cigarette) for at least 7 days prior to the assessment) over these time points.'}, {'measure': 'Smoking quantity across multiple time points', 'timeFrame': 'From intervention through 12 months post-intervention', 'description': 'The outcome measures smoking quantity (self-reported average cigarettes smoked per day for the past 30 days prior to the assessment) over these time points.'}, {'measure': 'Quit attempts', 'timeFrame': '6 and 12 months post-intervention', 'description': 'This outcome measures the number of quit attempts in the past 30 days prior to the assessment over these time points.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Genetics', 'Primary Care Physicians', 'Tobacco Treatment'], 'conditions': ['Smoking Cessation', 'Smoking', "Physician's Role"]}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://siteman.wustl.edu', 'label': 'Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine'}]}, 'descriptionModule': {'briefSummary': "This study evaluates the feasibility and preliminary effects of precision tobacco treatment, compared to usual care, on promoting tobacco treatment in oncology patients and providers in the oncology care setting. The precision treatment intervention includes personalized tobacco treatment recommendations using the patient's clinical, genetic, and biomarker information. This intervention may increase patient receipt of tobacco treatment, patient medication use, and patient smoking abstinence at 6 months.", 'detailedDescription': 'This study aims to promote the provision and use of evidence-based tobacco treatment and patient survival by integrating precision tobacco treatment into oncology care as a novel multilevel intervention. This study builds on growing evidence that 1) precision treatment may optimize treatment effectiveness by precisely matching patients with the safest, most effective medications available and 2) precision intervention may boost the implementation and effectiveness of tobacco treatment. The multilevel precision treatment intervention to be tested-PrecisionTx-- provides the opportunity to present personalized risk, benefit, and treatment recommendation to increase clinician ordering, patient uptake, and overall effectiveness of tobacco treatment.\n\nThis study aims to understand the feasibility and preliminary effects of precision treatment over usual care and associated mechanistic and implementation outcomes. Therefore, the investigators propose a 2-arm cluster randomized controlled trial of 16 clinicians and 96 patients (\\~6 per clinician) from oncology care settings. Clinicians and patients will be randomized with 1:1 allocation to usual care (UC) vs. precision treatment (PT) to evaluate the effect of precision treatment on patient receipt of tobacco treatment and smoking abstinence.\n\nIn Aim 1, the investigators will develop a contextually grounded multilevel PT intervention, PrecisionTx-Onc, for oncology/hematology clinics by engaging both patients and providers. In Aim 2, the investigators will conduct a 2-arm RCT to pilot the multilevel PT intervention for feasibility and determine preliminary estimates of clinical outcomes. Preliminary data will address hypotheses that the PT vs. the UC condition will produce superior physician prescribing as measured by patient receipt of prescription, patient medication use, and patient bioverified smoking abstinence at 6 months. Additional outcomes include patient quality of life and survival.\n\nIn Aim 3, the investigators will explore mechanisms of behavior change and implementation outcomes. The investigators will explore 1) mechanisms (e.g., outcome expectancies, perceived risk/benefit, and withdrawal suppression) underlying the effect of PT, and 2) implementation outcomes to evaluate its potential for scaling, using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework.\n\nPrimary outcomes include patient receipt of tobacco treatment, patient use of tobacco treatment, and patient smoking abstinence. Secondary outcomes include patient receipt of recommended medication, patient medication adherence, patient quality of life, patient survival, and additional patient smoking cessation outcomes. Mechanistic outcomes include clinician level (perceived benefit, outcome expectancy), clinician-patient interaction (self-efficacy), patient-level (perceived risk, outcome expectancy, withdrawal suppression, adverse events). Implementation outcomes will be evaluated based on the RE-AIM framework.\n\nThe study is an innovative paradigm shift from a traditional treatment model to precision treatment that includes both metabolic and genetic markers to motivate and guide tobacco treatment for both clinicians and patients, integrated within oncology care. This study will test the impact of a multilevel precision treatment intervention on improving tobacco treatment and health outcomes in oncology care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Eligibility Criteria for Clinicians:\n\n* Clinician from participating oncology/hematology clinic\n* At least 18 years of age\n* Can speak and understand English\n\nInclusion Criteria for Patients:\n\n* Patient at participating clinic\n* Age 18-89 years\n* Current smoking (average cigarettes per day ≥5)\n* Can speak and understand English\n* Willing to consider medication to help reduce craving or smoking such as nicotine patch, lozenge, or varenicline\n\nExclusion Criteria for Patients:\n\n* Active use of smoking cessation medication (within the past 30 days)\n* Receipt of smoking cessation medication or prescription for smoking cessation medication (within the past 30 days)\n* Having a contradiction for cNRT or varenicline (allergic reactions, current cardiac problems, pregnancy)\n* Patients who were deemed by the investigator to be ineligible for participation in the trial'}, 'identificationModule': {'nctId': 'NCT07166120', 'acronym': 'PROMISE', 'briefTitle': 'Precision Treatment to Promote Smoking Cessation and Survival in Oncology Patients', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Precision Treatment to Promote Smoking Cessation and Survival in Oncology Patients', 'orgStudyIdInfo': {'id': '202403025'}, 'secondaryIdInfos': [{'id': 'LC230570', 'type': 'OTHER_GRANT', 'domain': 'Department of Defense'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Care', 'description': 'The arm will represent usual care in the oncology care clinics. Clinicians will receive a report designed to recommend guideline-based tobacco treatment. Patients will receive a report on guideline-based advice about smoking cessation and a brief discussion with a behavior interventionist.', 'interventionNames': ['Behavioral: Usual care']}, {'type': 'EXPERIMENTAL', 'label': 'PrecisionTx-Onc (oncology)', 'description': 'Clinicians will receive PrecisionTx-Onc, an intervention designed to recommend precision tobacco treatment, adapted for oncology. Patients will receive PrecisionTx-Onc, an intervention designed to recommend precision tobacco treatment, and a brief discussion with a behavior interventionist, adapted for oncology.', 'interventionNames': ['Behavioral: Precision treatment']}], 'interventions': [{'name': 'Usual care', 'type': 'BEHAVIORAL', 'description': 'Usual care will be informed by practice guidelines (standard of care, brief advice, and guideline awareness).', 'armGroupLabels': ['Usual Care']}, {'name': 'Precision treatment', 'type': 'BEHAVIORAL', 'description': "Precision treatment will be informed by practice guidelines (standard of care, brief advice, and guideline awareness), plus patient-specific risk feedback and personalized tobacco treatment recommendations using patients' clinical, genetic, and biomarker information, adapted for oncology.", 'armGroupLabels': ['PrecisionTx-Onc (oncology)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Li-Shiun Chen, ScD, M.D., MPH', 'role': 'CONTACT', 'email': 'li-shiun@wustl.edu', 'phone': '314-362-3932'}, {'name': 'Theodore Thomas, M.D.', 'role': 'CONTACT', 'email': 'thomast@wustl.edu'}, {'name': 'Li-Shiun Chen, ScD, M.D., MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ramaswamy Govindan, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Theodore Thomas, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'centralContacts': [{'name': 'Li-Shiun Chen, ScD, M.D., MPH', 'role': 'CONTACT', 'email': 'li-shiun@wustl.edu', 'phone': '314-362-3932'}, {'name': 'Theodore Thomas, M.D.', 'role': 'CONTACT', 'email': 'thomast@wustl.edu'}], 'overallOfficials': [{'name': 'Li-Shiun Chen, ScD, M.D., MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Department of Defense', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}