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

NCT06445192 | Active Not Recruiting DMC

• 2 other identifiers: OSU-22194NCI-2023-05556
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Carcinoma

Outcome Measures

Primary Outcomes (4)

• 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)

Study Arms (2)

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.

Procedure: Biospecimen Collection; Other: Exercise Counseling; Other: Exercise Intervention; Other: Medical Device Usage and Evaluation; Other: Physical Performance Testing; Other: Questionnaire Administration; Other: Telemedicine

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.

Other: Best Practice; Procedure: Biospecimen Collection; Other: Medical Device Usage and Evaluation; Other: Physical Performance Testing; Other: Questionnaire Administration

Interventions

Exercise Counseling OTHER

Attend group counseling

Group I (exercise intervention)

Exercise Intervention OTHER

Receive aerobic and resistance exercise intervention via telehealth

Group I (exercise intervention)

Medical Device Usage and Evaluation OTHER

Wear Fitbit

Group I (exercise intervention); Group II (usual care)

Physical Performance Testing OTHER

Ancillary studies

Also known as: Physical Fitness Testing, Physical Function Testing

Group I (exercise intervention); Group II (usual care)

Questionnaire Administration OTHER

Ancillary studies

Group I (exercise intervention); Group II (usual care)

Telemedicine OTHER

Receive aerobic and resistance exercise intervention via telehealth

Also known as: Telehealth

Group I (exercise intervention)

Best Practice OTHER

Receive usual care

Also known as: standard of care, standard therapy

Group II (usual care)

Biospecimen Collection PROCEDURE

Undergo collection of blood samples

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Group I (exercise intervention); Group II (usual care)

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• Current or former smoker with 20-pack year smoking history and within the last 15 years
• Fewer than 150 minutes of participation in moderate intensity physical activity each week
• 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
• Willing to sign an informed consent

You may not qualify if:

• Person undergoing treatment for cancer in any form
• Person plans to enter smoking cessation or change status

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Practice Guidelines as Topic; Standard of Care; Specimen Handling; Exercise Test; Telemedicine

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Delivery of Health Care; Patient Care Management

Study Officials

• Marisa Bittoni, PhD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessments will be obtained by research staff blinded to treatment group assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: June 6, 2024
• Study Start: November 3, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)