Prehabilitation Physical Therapy and Relaxation Intervention Program to Promote Resiliency and Operative Success Among Adults Receiving Lung Cancer Surgery, ROAR-LCS Trial

LiveWellLung: A Prehabilitation Intervention Program to Promote Resiliency and Operative Success Among Adults Receiving Lung Cancer Surgery (ROAR-LCS) With Biospecimen Collection

This clinical trial tests two different physical therapy and relaxation interventions, one in-person and at-home called Resiliency and Operative Success for Adults Receiving Lung Cancer Surgery (ROAR-LCS) and one virtually called BeFitMe. These programs that take place before and after standard of care lung cancer surgery, called prehabilitation programs, promote resiliency and patient outcomes (operative success) for adults receiving lung cancer surgery. Lung cancers occur in the chest and often cause symptoms for patients. Poor physical performance and negative mood are two risk factors for a decline in functional status after surgery. Physical therapy and relaxation interventions (i.e. progressive muscle relaxation) are two such interventions that may improve physical and emotional recovery including a potential shortened hospital stay for patients receiving surgery for lung cancer. Starting these intervention programs early alongside cancer treatment can improve symptoms, improve functional status and quality of life, help with emotional needs of patients, improve recovery time, and may even prolong life. ROAR-LCS and BeFitMe may promote resiliency and operative success for adults receiving lung cancer surgery.

Study Overview

• Status: Recruiting
• Conditions: Resectable Lung Non-Small Cell Carcinoma
• Intervention / Treatment: Procedure: Biospecimen Collection; Other: Survey Administration; Other: Exercise Intervention; Other: Exercise Intervention; Other: Exercise Intervention; Procedure: Physical Therapy; Behavioral: Relaxation Technique; Other: Internet-Based Intervention; Other: Text Message-Based Navigation Intervention

Detailed Description

PRIMARY OBJECTIVE:

I. To evaluate feasibility of the two peri-operative programs, as defined by participant adherence and retention rates within their respective interventions.

EXPLORATORY OBJECTIVE:

I. Associating gut microbiome diversity and T cell senescence profiles (peripheral blood) at baseline and end of study as potential biomarkers of treatment-related toxicity and tumor response to treatment among other clinical secondary outcomes (e.g. surgical complications, overall survival).

OUTLINE: Patients choose which arm (I or II) they would like to participate in, depending upon availability.

ARM I (ROAR-LCS): Patients complete in person physical therapy sessions during weeks with regularly scheduled clinic visits, at first session after surgery, and the final session. These sessions include 10 minutes of a cardiovascular warm up followed up core exercise and resistance training. Patients also complete virtual physical therapy sessions in a similar fashion during weeks in between regularly scheduled clinic visits. Patients complete 6-8 sessions prior to surgery and 12 sessions total (over 3-4 months). Patients receive a portable exercise peddler and resistance bands for at home exercise. Patients complete the exercises at home as instructed during their sessions, at first weekly then increased to twice then three times weekly depending upon tolerance. Patients also complete progressive muscle relaxation exercises during a guided virtual session once weekly and at home individually 3-5 times per week. Patients also undergo blood sample collection on study.

ARM II (BeFitMe): Patients receive access to the BeFitMe application (app) on their smartphone and an Apple watch and exercise flip book for 9 months. Patients are assigned exercises, lasting at least 3 minutes, and receive access to self guided exercise videos. Patients receive motivational text messages to encourage their completion of the exercises once daily. Patients track their exercise and step counts using the app. Patients also undergo blood sample collection on study.

After completion of study intervention, patients are followed up at 1 and 2 years.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: The Ohio State University Comprehensive Cancer Center; Phone Number: 800-293-5066; Email: OSUCCCClinicaltrials@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • Ohio State University Comprehensive Cancer Center
      • Contact: Carolyn J. Presley, MD; Phone Number: 614-293-6453; Email: carolyn.presley@osumc.edu
      • Principal Investigator: Carolyn J. Presley, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 18 years
• Diagnosed with: potentially resectable non small cell lung cancer (NSCLC) stage (9th edition: IB-IIIB)
• Intent to receive surgery following neoadjuvant systemic therapy from the Ohio State University Comprehensive Cancer Center (OSUCCC) Thoracic Oncology Clinic
• Patients who are at least 6 weeks out of the surgery date are eligible to participate
• Willingness to participate and adhere to the study intervention program
• Ability to understand and willingness to sign an informed consent document

Exclusion Criteria:

• Prisoners are excluded from participation
• There is NO exclusion criteria pertaining to Eastern Cooperative Oncology Group (ECOG) performance status, laboratory values, or prior cancer diagnoses
• Patients already enrolled on a therapeutic clinical trial will be excluded from this study as to not confound any exploratory outcomes associated with this trial and/or any clinical trials evaluating novel anti-cancer therapies unless granted permission by the local site principal investigator (PI)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (ROAR-LCS); Patients complete in person physical therapy sessions during weeks with regularly scheduled clinic visits, at first session after surgery, and the final session. These sessions include 10 minutes of a cardiovascular warm up followed up core exercise and resistance training. Patients also complete virtual physical therapy sessions in a similar fashion during weeks in between regularly scheduled clinic visits. Patients complete 6-8 sessions prior to surgery and 12 sessions total (over 3-4 months). Patients receive a portable exercise peddler and resistance bands for at home exercise. Patients complete the exercises at home as instructed during their sessions, at first weekly then increased to twice then three times weekly depending upon tolerance. Patients also complete progressive muscle relaxation exercises during a guided virtual session once weekly and at home individually 3-5 times per week. Patients also undergo blood sample collection on study.	Procedure: Biospecimen Collection; Undergo blood sample collection; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection; Other: Survey Administration; Ancillary studies; Other: Exercise Intervention; Complete exercises at home; Other: Exercise Intervention; Receive portable exercise peddler and resistance bands; Other: Exercise Intervention; Complete assigned exercises; Procedure: Physical Therapy; Complete physical therapy sessions; Other Names: PT; Physiatric Procedure; Physical Medicine Procedure; Physical Therapeutics; Physical Therapy Procedure; Physiotherapy; Physiotherapy Procedure; Behavioral: Relaxation Technique; Complete progressive muscle relaxation
Experimental: Arm II (BeFitMe); Patients receive access to the BeFitMe app on their smartphone and an Apple watch and exercise flip book for 9 months. Patients are assigned exercises, lasting at least 3 minutes, and receive access to self guided exercise videos. Patients receive motivational text messages to encourage their completion of the exercises once daily. Patients track their exercise and step counts using the app. Patients also undergo blood sample collection on study.	Procedure: Biospecimen Collection; Undergo blood sample collection; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection; Other: Survey Administration; Ancillary studies; Other: Exercise Intervention; Complete exercises at home; Other: Exercise Intervention; Receive portable exercise peddler and resistance bands; Other: Exercise Intervention; Complete assigned exercises; Other: Internet-Based Intervention; Receive access to the BeFitMe application; Other: Text Message-Based Navigation Intervention; Receive motivational text messages; Other Names: Automated Text Message-Based Navigation; Text Message-Based Navigation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence (feasibility)	Defined as completion of ≥ 8 of the program sessions (Resiliency and Operative Success among Adults Receiving Lung Cancer Surgery [ROAR-LCS]) and 3 out of the 5 repeated assessments (BeFitMe) at the end of the study period, whichever occurs first.	At 12 week follow up session
Retention (feasibility)	Defined as the percentage of participants not lost to follow-up at 12 weeks (pre-operative), post-operative (around 12 weeks), and 6 months post recruitment.	Up to 6 months post recruitment

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Investigators: Principal Investigator: Carolyn J Presley, MD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: May 7, 2026
• First Submitted That Met QC Criteria: May 7, 2026
• First Posted (Actual): May 13, 2026

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Investigative Techniques; Therapeutics; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Mind-Body Therapies; Complementary Therapies; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Rehabilitation; Specimen Handling; Physical Therapy Modalities; Relaxation Therapy
• Other Study ID Numbers: OSU-24288 (Other Identifier: Ohio State University Comprehensive Cancer Center); NCI-2026-02426 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No