Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2026-01-01 @ 9:40 PM
Study NCT ID:
NCT06445192
Status:
RECRUITING
Last Update Posted:
2025-06-03
First Post:
2023-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Impact of a Virtually Supervised Exercise Intervention and Group Counseling on Inflammation and the Microbiome of Smokers at High Risk for Lung Cancer, BE FIT Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017410', 'term': 'Practice Guidelines as Topic'}, {'id': 'D059039', 'term': 'Standard of Care'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D005080', 'term': 'Exercise Test'}, {'id': 'D017216', 'term': 'Telemedicine'}], 'ancestors': [{'id': 'D017408', 'term': 'Guidelines as Topic'}, {'id': 'D011785', 'term': 'Quality Assurance, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D016552', 'term': 'Ergometry'}, {'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcome assessments will be obtained by research staff blinded to treatment group assignment.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 88}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-28', 'studyFirstSubmitDate': '2023-10-17', 'studyFirstSubmitQcDate': '2024-05-31', 'lastUpdatePostDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients recruited to virtually-delivered exercise intervention (feasibility)', 'timeFrame': 'Up to 1 year', 'description': 'To evaluate the feasibility and preliminary efficacy of establishing a multi-component virtually-delivered exercise intervention trial with longitudinal biomarker and microbiome collection in the Ohio State University Lung Cancer Screening Clinic (OSULCSC)'}, {'measure': 'Proportion of patients who achieve study adherence (feasibility) based on attendance to the exercise program sessions and biospecimens submitted.', 'timeFrame': 'During 12-week program', 'description': 'Study adherence is defined as a) the proportion of patients attending at least 20 out of 24 sessions for the 12-week program and b) the percentage of biospecimen samples collected at the post program period (12 weeks). This study will be considered feasible if the compliance rate for both of these combined is 75% or more. Descriptive statistics will be used to examine the distribution of all patient and treatment characteristics, including compliance.'}, {'measure': 'Assess the number of participants with a change in inflammatory biomarkers', 'timeFrame': 'Baseline to post-intervention (12 weeks)', 'description': 'Will assess the effect of the intervention on inflammatory markers of C-reactive protein and IL-6 separately using linear mixed models with the biomarker serving as the outcome variable. Will also assess the changes in the biomarkers across time in each intervention group.'}, {'measure': 'Microbe relative abundances', 'timeFrame': 'Baseline to post-intervention (12 weeks)', 'description': "Will assess the effect of the intervention on the diversity and relative abundances of individual microbes. Will compare everyone's post-intervention time point to baseline in control and the exercise interventions cohorts, applying linear or generalized mixed-effects models for the diversity or individual microbes."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Carcinoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://cancer.osu.edu', 'label': 'The Jamesline'}]}, 'descriptionModule': {'briefSummary': 'This phase II trial evaluates how a virtually supervised exercise intervention in combination with group counseling affects inflammation and the bacterial composition (microbiome) of the gut in smokers who are at high risk for lung cancer. Physical exercise has been shown to reduce lung cancer development and to have beneficial effects on the gut microbiome and inflammation. Group counseling may promote adherence to the exercise intervention by empowering participants to exert greater control over their behavior and environment. This clinical trial may help researchers understand how exercise impacts inflammation and the microbiome in people at risk for lung cancer and whether or not exercise with counseling can improve health outcomes in high-risk individuals.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To evaluate the feasibility and preliminary efficacy of establishing a multi-component virtually-delivered exercise intervention trial with longitudinal biomarker and microbiome collection in the Ohio State University Lung Cancer Screening Clinic (OSULCSC).\n\nII. To determine the impact of the multi-component virtually-delivered exercise intervention on the microbiome and inflammatory biomarkers.\n\nOUTLINE: Participants are randomized to 1 of 2 groups.\n\nGROUP I: Participants receive the supervised aerobic and resistance exercise intervention over 1 hour via telehealth twice a week (BIW) in weeks 1-8 and once a week (QW) in weeks 9-12 and then continue with unsupervised exercise sessions BIW in weeks 13-52. Participants also attend group counseling sessions over 1 hour QW in weeks 1-8 and bi-weekly in weeks 9-12. Participants also wear a Fitbit throughout the trial and undergo collection of blood samples at baseline and follow up.\n\nGROUP II: Participants receive usual care consisting of education on standard recommendations for physical activity, the benefits of exercise, and an example of a light walking program. Participants also wear a Fitbit throughout the trial and undergo collection of blood samples at baseline and follow up.\n\nAfter completion of study intervention, participants are followed up at 12 weeks and 1 year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 50-77 years of age\n* Current or former smoker with 20-pack year smoking history and within the last 15 years\n* Fewer than 150 minutes of participation in moderate intensity physical activity each week\n* All participants must be free of severe heart, respiratory (e.g. chronic obstructive pulmonary disease \\[COPD\\]), or systemic disease that would make moderate intensity exercise participation unsafe\n* Willing to sign an informed consent\n\nExclusion Criteria:\n\n* Person undergoing treatment for cancer in any form\n* Person plans to enter smoking cessation or change status'}, 'identificationModule': {'nctId': 'NCT06445192', 'briefTitle': 'Evaluating the Impact of a Virtually Supervised Exercise Intervention and Group Counseling on Inflammation and the Microbiome of Smokers at High Risk for Lung Cancer, BE FIT Trial', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University Comprehensive Cancer Center'}, 'officialTitle': 'The BE FIT Study: Feasibility of an Exercise Intervention on Microbiome and Immune Function in a High-Risk Cohort for Lung Cancer', 'orgStudyIdInfo': {'id': 'OSU-22194'}, 'secondaryIdInfos': [{'id': 'NCI-2023-05556', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group I (exercise intervention)', 'description': 'Participants receive the supervised aerobic and resistance exercise intervention over 1 hour via telehealth BIW in weeks 1-8 and QW in weeks 9-12 and then continue with unsupervised exercise sessions BIW in weeks 13-52. Participants also attend group counseling sessions over 1 hour QW in weeks 1-8 and bi-weekly in weeks 9-12. Participants also wear a Fitbit throughout the trial and undergo collection of blood samples at baseline and follow up.', 'interventionNames': ['Procedure: Biospecimen Collection', 'Other: Exercise Counseling', 'Other: Exercise Intervention', 'Other: Medical Device Usage and Evaluation', 'Other: Physical Performance Testing', 'Other: Questionnaire Administration', 'Other: Telemedicine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group II (usual care)', 'description': 'Participants receive usual care consisting of education on standard recommendations for physical activity, the benefits of exercise, and an example of a light walking program. Participants also wear a Fitbit throughout the trial and undergo collection of blood samples at baseline and follow up.', 'interventionNames': ['Other: Best Practice', 'Procedure: Biospecimen Collection', 'Other: Medical Device Usage and Evaluation', 'Other: Physical Performance Testing', 'Other: Questionnaire Administration']}], 'interventions': [{'name': 'Best Practice', 'type': 'OTHER', 'otherNames': ['standard of care', 'standard therapy'], 'description': 'Receive usual care', 'armGroupLabels': ['Group II (usual care)']}, {'name': 'Biospecimen Collection', 'type': 'PROCEDURE', 'otherNames': ['Biological Sample Collection', 'Biospecimen Collected', 'Specimen Collection'], 'description': 'Undergo collection of blood samples', 'armGroupLabels': ['Group I (exercise intervention)', 'Group II (usual care)']}, {'name': 'Exercise Counseling', 'type': 'OTHER', 'description': 'Attend group counseling', 'armGroupLabels': ['Group I (exercise intervention)']}, {'name': 'Exercise Intervention', 'type': 'OTHER', 'description': 'Receive aerobic and resistance exercise intervention via telehealth', 'armGroupLabels': ['Group I (exercise intervention)']}, {'name': 'Medical Device Usage and Evaluation', 'type': 'OTHER', 'description': 'Wear Fitbit', 'armGroupLabels': ['Group I (exercise intervention)', 'Group II (usual care)']}, {'name': 'Physical Performance Testing', 'type': 'OTHER', 'otherNames': ['Physical Fitness Testing', 'Physical Function Testing'], 'description': 'Ancillary studies', 'armGroupLabels': ['Group I (exercise intervention)', 'Group II (usual care)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Group I (exercise intervention)', 'Group II (usual care)']}, {'name': 'Telemedicine', 'type': 'OTHER', 'otherNames': ['Telehealth'], 'description': 'Receive aerobic and resistance exercise intervention via telehealth', 'armGroupLabels': ['Group I (exercise intervention)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Marisa Bittoni, PhD', 'role': 'CONTACT', 'email': 'Marisa.Bittoni@osumc.edu', 'phone': '614-206-3518'}, {'name': 'Marisa Bittoni, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ohio State University Comprehensive Cancer Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'centralContacts': [{'name': 'The Ohio State Comprehensive Cancer Center', 'role': 'CONTACT', 'email': 'OSUCCCClinicaltrials@osumc.edu', 'phone': '800-293-5066'}], 'overallOfficials': [{'name': 'Marisa Bittoni, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University Comprehensive Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University Comprehensive Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Marisa Bittoni', 'investigatorAffiliation': 'Ohio State University Comprehensive Cancer Center'}}}}