Exercise and Counseling for Lung Cancer Prevention

Overseen By The Ohio State Comprehensive Cancer Center

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University Comprehensive Cancer Center

Must not be taking: Immunosuppressants, Steroids, Anticoagulants, others

Disqualifiers: Cancer treatment, Smoking cessation, Severe heart disease

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 20

Duration: 12 weeks

88 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a combination of exercise and group counseling might lower inflammation and alter gut bacteria in individuals who smoke and are at high risk for lung cancer. The goal is to determine if exercise can reduce lung cancer risk by positively affecting the body’s natural defenses. Participants will either engage in a virtually supervised exercise intervention with counseling or receive standard care advice for physical activity. The trial seeks current or former smokers who are not very active and have a significant smoking history but do not have severe heart or lung diseases. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to new preventive strategies for lung cancer.

Will I have to stop taking my current medications?

If you are taking immunosuppressants, bisphosphonates, steroids, anticoagulants, warfarin, apixaban, or probiotics, you will need to stop these medications to participate in the trial.

What prior data suggests that this exercise intervention and counseling are safe for high-risk individuals?

Research shows that online-supervised exercise programs are generally safe and helpful. Cancer patients have used these programs and improved their physical abilities. No specific safety concerns have been reported, suggesting these exercises are well-tolerated.

Studies on group counseling, such as supportive-expressive therapy, have shown benefits like reduced stress and improved mood. Although detailed safety information is limited, no major safety issues have been reported. These treatments are common and usually safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential of virtually supervised exercise and counseling as a preventive approach for lung cancer. Unlike traditional interventions that might focus on medication or surgery, this method emphasizes a proactive lifestyle change through aerobic and resistance exercises conducted via telehealth. Participants also receive regular group counseling, which is not typically part of standard care. This trial is particularly innovative because it leverages technology, like Fitbits, to monitor progress, encouraging a more personalized and engaging form of cancer prevention.

What evidence suggests that this virtually supervised exercise intervention with group counseling is effective for lung cancer prevention?

This trial will compare a virtually supervised exercise intervention with usual care. Research has shown that exercise can reduce inflammation and improve gut health in people at risk for lung cancer. The virtually supervised exercise program, which participants in this trial may receive, has led to significant health improvements for lung cancer patients, including better fitness and less fatigue. Group counseling, also part of the exercise intervention arm, helps people maintain exercise routines by encouraging positive behavioral changes. It also reduces stress and improves mood among cancer patients. Together, these approaches may offer a promising way to improve health outcomes for smokers at high risk of lung cancer. ^{1 6 7 8 9}

Who Is on the Research Team?

Marisa Bittoni, PhD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for smokers at high risk of developing lung cancer. Participants will engage in a supervised exercise program and group counseling, all delivered virtually. To join, individuals must be willing to perform physical exercises, use medical devices as needed, provide biospecimens like blood or stool samples, and complete questionnaires.

Inclusion Criteria

Willing to sign an informed consent

Fewer than 60 minutes of participation in moderate intensity physical activity each week

I am between 50 and 77 years old.

Exclusion Criteria

I am currently taking medications like immunosuppressants, steroids, or blood thinners.

I am currently receiving treatment for cancer.

Person plans to enter smoking cessation or change status

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a virtually supervised aerobic and resistance exercise intervention and group counseling sessions

12 weeks

Telehealth sessions twice a week for 8 weeks, then once a week for 4 weeks

Extended Treatment

Participants continue with unsupervised exercise sessions and wear a Fitbit for monitoring

40 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Follow-up at 12 weeks and 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Group Counseling
• Virtually Supervised Exercise Intervention

Trial Overview The BE FIT Trial is testing whether virtual exercise programs combined with group counseling can reduce inflammation and positively change the gut's bacterial makeup in people at high risk for lung cancer. It involves regular physical performance tests and telemedicine check-ins.

How Is the Trial Designed?

Group I: Group I (exercise intervention) Experimental Treatment 7 Interventions

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.

Group II: Group II (usual care) Active Control 5 Interventions

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.

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

Published Research Related to This Trial

Exercise interventions for lung cancer patients are both safe and effective, leading to improvements in physical fitness, muscle strength, and quality of life, as well as reductions in cancer-related fatigue and dyspnoea.

Prehabilitation, or exercising before treatment, has been shown to enhance recovery outcomes after surgery, highlighting the importance of individualized exercise plans throughout the cancer care journey.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity for people with lung cancer. Edbrooke, L., Granger, CL., Denehy, L.[2020]

Postoperative exercise interventions for surgical lung cancer patients have high to moderate-quality evidence showing they can significantly improve exercise capacity and muscle strength, which are crucial for recovery.

Preoperative exercise interventions may also enhance exercise capacity and pulmonary function, reduce the risk of postoperative complications, and shorten hospital stays, although the evidence quality is lower.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of perioperative exercise interventions on lung cancer patients: An overview of systematic reviews. Zhou, W., Woo, S., Larson, JL.[2021]

Exercise interventions for lung cancer patients significantly reduce post-operative complications and improve exercise capacity, based on a systematic review of 30 studies involving a total of 6440 participants.

While exercise showed benefits in pre- and post-operative settings, health-related quality of life improvements were mostly non-significant, indicating a need for further high-quality research, especially in non-surgical populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise across the Lung Cancer Care Continuum: An Overview of Systematic Reviews. Edbrooke, L., Bowman, A., Granger, CL., et al.[2023]

Lung cancer survivors showed a preference for starting exercise programs during adjuvant treatment, especially those who had undergone lung surgery, indicating the importance of tailoring exercise timing to individual treatment experiences.

Exercise levels significantly declined after diagnosis, but engaging in exercise post-treatment was associated with improved quality of life and reduced fatigue, highlighting the potential benefits of exercise for recovery in lung cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise preferences, levels and quality of life in lung cancer survivors. Leach, HJ., Devonish, JA., Bebb, DG., et al.[2018]

In a review of over 5,500 participants from 11 physical activity interventions, no serious study-related adverse events were reported, indicating a high level of safety in these exercise programs.

While minor musculoskeletal injuries were noted, the studies emphasized a 'start low and go slow' approach, suggesting that moderate-intensity physical activity is safe and effective for sedentary, chronically ill, or older populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening, safety, and adverse events in physical activity interventions: collaborative experiences from the behavior change consortium. Ory, M., Resnick, B., Jordan, PJ., et al.[2022]

The exercise intervention for women with stage II+ breast cancer was safe, with no serious exercise-related adverse events reported, and both low and high supervision groups showed high compliance to the exercise dosage.

Both groups experienced improvements in quality of life, physical activity, and fitness, but only the high-supervision group demonstrated significant gains in strength and self-efficacy, suggesting that more supervision may enhance certain benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomised, Comparative, Effectiveness Trial Evaluating Low- versus High-Level Supervision of an Exercise Intervention for Women with Breast Cancer: The SAFE Trial. Spence, RR., Sandler, CX., Singh, B., et al.[2023]

The 8-week group-based physical activity program delivered via videoconferencing was feasible and well-accepted by cancer survivors, with high enrollment (61 out of 65 interested) and retention rates (86.9%).

Participants showed significant improvements in physical activity levels, muscular endurance, and quality of life after the program, indicating that this innovative approach may effectively support cancer survivors in increasing their physical activity and overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Group-Based, Videoconference-Delivered Physical Activity Program for Cancer Survivors. Leach, HJ., Crisafio, ME., Howell, MJ., et al.[2023]

Exercise can significantly benefit lung cancer patients by improving strength, endurance, and emotional well-being, regardless of the stage of their illness.

A structured recovery fitness program that includes breathing exercises, stretching, aerobic activities, and strength training is recommended to support lung cancer survivors and address their diverse needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The importance of exercise in lung cancer treatment. Michaels, C.[2020]

Supervised exercise in community settings for cancer patients is seen as a meaningful and feasible task by physical therapists and personal trainers, enhancing their confidence in promoting health during treatment.

However, challenges arise from conflicting advice given to patients about exercising during treatment, highlighting the need for better communication between oncology care and exercise professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Phys-Can study: meaningful and challenging - supervising physical exercise in a community-based setting for persons undergoing curative oncological treatment. Henriksson, A., Igelström, H., Arving, C., et al.[2022]

Exercise training is a safe and feasible adjunct therapy for patients with operable lung cancer, both before and after surgery, helping to improve their ability to tolerate exercise and potentially enhancing their quality of life.

For patients with inoperable lung cancer, while more research is needed, preliminary evidence indicates that carefully prescribed exercise training could also be beneficial and should be considered in their overall treatment plan.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise therapy across the lung cancer continuum. Jones, LW., Eves, ND., Waner, E., et al.[2021]

The LUNGEVITY trial will evaluate the effects of different exercise training types on cardiorespiratory fitness (VO2peak) and patient-reported outcomes in 160 post-operative non-small cell lung cancer patients over 16 weeks.

The study aims to determine the most effective exercise regimen (aerobic, resistance, or a combination) for improving fitness and quality of life, which could lead to new rehabilitation guidelines for lung cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The lung cancer exercise training study: a randomized trial of aerobic training, resistance training, or both in postsurgical lung cancer patients: rationale and design. Jones, LW., Eves, ND., Kraus, WE., et al.[2021]

Pre-surgery exercise interventions significantly improve physical and pulmonary function in lung cancer patients, which can enhance their ability to undergo surgery and reduce complications afterward.

Post-surgery exercise interventions show inconsistent results, with some studies reporting no significant effects, highlighting the need for more research on the timing and setting of exercise programs in lung cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise and lung cancer surgery: A systematic review of randomized-controlled trials. Himbert, C., Klossner, N., Coletta, AM., et al.[2023]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2589979124000192

Pilot implementation of group-based psychotherapy led by ... This is the first study to evaluate the effectiveness of group-based psychotherapy in NSCLC patients with depression in Vietnam during the COVID-19 pandemic.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11857804/

Review of Psychological Interventions in Oncology Supportive–expressive group therapy (SEGT) significantly reduced traumatic stress symptoms, mood disturbances, and pain perception.

3. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-024-07954-9

Effectiveness of structured psycho-oncological counseling for ... This trial aims to evaluate structured psycho-oncological counseling for relatives of lung cancer patients based on the Managing Cancer And Living Meaningfully ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165032722004967

Effectiveness comparisons of various psychosocial ... Our NMA results showed that three psychosocial intervention therapies were effective for CRF in cancer patients.

5. nature.com nature.com/articles/s41598-024-63431-y

Psychological intervention improves quality of life in ... The results for the cancer stage suggest that psychological interventions are most effective when provided in the early stages rather than in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10858519/

Effectiveness of structured psycho-oncological counseling ... This trial aims to evaluate structured psycho-oncological counseling for relatives of lung cancer patients based on the Managing Cancer And Living Meaningfully ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT00494910?intr=Group%20therapy&aggFilters=status:&lastUpdPost=2017-11-01_&viewType=Table&rank=4

Randomized Controlled Trial of Group Psychotherapy ... The purpose of this study is to compare two types of group counseling for cancer patients: Meaning-Centered counseling and Supportive counseling. Many cancer ...

8. withpower.com withpower.com/trial/behavioral-intervention-for-lung-cancer-a4e48

Behavioral Intervention for Lung Cancer (LuCA Trial) Is the LuCA Behavioral Intervention safe for humans? There is limited specific safety data available for the LuCA Behavioral Intervention itself, but behavioral ...

9. dovepress.com dovepress.com/staged-cbi-for-reducing-anxiety-and-depression-in-lung-cancer-patients-peer-reviewed-fulltext-article-JMDH

Staged Cognitive Behavioral Intervention (CBI) for Lung ... Cancer patients' thoughts can be eased, and the strain of diagnosis and treatment can be lessened using CBI. Findings reveal that patients have ...