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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-05556 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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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.
PRIMARY OBJECTIVES:
I. 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).
II. To determine the impact of the multi-component virtually-delivered exercise intervention on the microbiome and inflammatory biomarkers.
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP 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.
GROUP 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.
After completion of study intervention, participants are followed up at 12 weeks and 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (exercise intervention) | Experimental | 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. |
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| Group II (usual care) | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice | Other | Receive usual care |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of patients recruited to virtually-delivered exercise intervention (feasibility) | 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) | Up to 1 year |
| Proportion of patients who achieve study adherence (feasibility) based on attendance to the exercise program sessions and biospecimens submitted. | 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. | During 12-week program |
| Assess the number of participants with a change in inflammatory biomarkers | 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. | Baseline to post-intervention (12 weeks) |
| Microbe relative abundances | 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. | Baseline to post-intervention (12 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marisa Bittoni, PhD | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
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| Label | URL |
|---|---|
| The Jamesline | View source |
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Outcome assessments will be obtained by research staff blinded to treatment group assignment.
| Biospecimen Collection | Procedure | Undergo collection of blood samples |
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| Exercise Counseling | Other | Attend group counseling |
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| Exercise Intervention | Other | Receive aerobic and resistance exercise intervention via telehealth |
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| Medical Device Usage and Evaluation | Other | Wear Fitbit |
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| Physical Performance Testing | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| Telemedicine | Other | Receive aerobic and resistance exercise intervention via telehealth |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| D013048 | Specimen Handling |
| D005080 | Exercise Test |
| D017216 | Telemedicine |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D016552 | Ergometry |
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
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