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

NCT07584239 | Not Yet Recruiting DMC

• 2 other identifiers: OSU-24288NCI-2026-02426
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Resectable Lung Non-Small Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Arm I (ROAR-LCS)

EXPERIMENTAL

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; Other: Exercise Intervention; Procedure: Physical Therapy; Behavioral: Relaxation Technique; Other: Survey Administration

Arm II (BeFitMe)

EXPERIMENTAL

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; Other: Exercise Intervention; Other: Internet-Based Intervention; Other: Survey Administration; Other: Text Message-Based Navigation Intervention

Interventions

Biospecimen Collection PROCEDURE

Undergo blood sample collection

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

Arm I (ROAR-LCS); Arm II (BeFitMe)

Exercise Intervention OTHER

Complete exercises at home

Arm I (ROAR-LCS)

Internet-Based Intervention OTHER

Receive access to the BeFitMe application

Arm II (BeFitMe)

Physical Therapy PROCEDURE

Complete physical therapy sessions

Also known as: Physiatric Procedure, Physical Medicine Procedure, Physical Therapeutics, Physical Therapy Procedure, Physiotherapy, Physiotherapy Procedure, PT

Arm I (ROAR-LCS)

Relaxation Technique BEHAVIORAL

Complete progressive muscle relaxation

Arm I (ROAR-LCS)

Survey Administration OTHER

Ancillary studies

Arm I (ROAR-LCS); Arm II (BeFitMe)

Text Message-Based Navigation Intervention OTHER

Receive motivational text messages

Also known as: Automated Text Message-Based Navigation, Text Message-Based Navigation

Arm II (BeFitMe)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Prisoners are excluded from participation
• 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)

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

Interventions

Specimen Handling; Physical Therapy Modalities; Relaxation Therapy

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Therapeutics; Rehabilitation; Mind-Body Therapies; Complementary Therapies; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Carolyn J Presley, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

The Ohio State University Comprehensive Cancer Center

CONTACT

800-293-5066; OSUCCCClinicaltrials@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients choose which arm they would like to participate in with a maximum of 15 patients in each arm. Patients choose on a first come first serve basis.

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: May 13, 2026
• Study Start (Estimated): July 15, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 13, 2026

Record last verified: 2026-05

Locations

US (1)