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Trial 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
NCT ID:
NCT06445192
Condition:
Lung Carcinoma
Conditions: Official terms:
Lung Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Single (Outcomes Assessor)
Masking description:
Outcome assessments will be obtained by research staff blinded to treatment group
assignment.
Intervention:
Intervention type:
Other
Intervention name:
Best Practice
Description:
Receive usual care
Arm group label:
Group II (usual care)
Other name:
standard of care
Other name:
standard therapy
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo collection of blood samples
Arm group label:
Group I (exercise intervention)
Arm group label:
Group II (usual care)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Other
Intervention name:
Exercise Counseling
Description:
Attend group counseling
Arm group label:
Group I (exercise intervention)
Intervention type:
Other
Intervention name:
Exercise Intervention
Description:
Receive aerobic and resistance exercise intervention via telehealth
Arm group label:
Group I (exercise intervention)
Intervention type:
Other
Intervention name:
Medical Device Usage and Evaluation
Description:
Wear Fitbit
Arm group label:
Group I (exercise intervention)
Arm group label:
Group II (usual care)
Intervention type:
Other
Intervention name:
Physical Performance Testing
Description:
Ancillary studies
Arm group label:
Group I (exercise intervention)
Arm group label:
Group II (usual care)
Other name:
Physical Fitness Testing
Other name:
Physical Function Testing
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Group I (exercise intervention)
Arm group label:
Group II (usual care)
Intervention type:
Other
Intervention name:
Telemedicine
Description:
Receive aerobic and resistance exercise intervention via telehealth
Arm group label:
Group I (exercise intervention)
Other name:
Telehealth
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.
Detailed description:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 50-77 years of age
- Current or former smoker with 20-pack year smoking history and within the last 15
years
- Fewer than 60 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
Exclusion Criteria:
- Person is on a regimen of the following medications: immunosuppressants,
bisphosphonates, steroids, anticoagulants, warfarin, apixaban, probiotics
- Person undergoing treatment for cancer in any form
- Person plans to enter smoking cessation or change status
Gender:
All
Minimum age:
55 Years
Maximum age:
77 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Ohio State University Comprehensive Cancer Center
Address:
City:
Columbus
Zip:
43210
Country:
United States
Status:
Recruiting
Contact:
Last name:
Marisa Bittoni, PhD
Phone:
614-206-3518
Email:
Marisa.Bittoni@osumc.edu
Investigator:
Last name:
Marisa Bittoni, PhD
Email:
Principal Investigator
Start date:
November 3, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Ohio State University Comprehensive Cancer Center
Agency class:
Other
Source:
Ohio State University Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06445192
http://cancer.osu.edu
