Recruiting

ROAR-LCS & BeFitMe

Sponsor:

Ohio State University Comprehensive Cancer Center

Code:

NCT07584239

Conditions

Resectable Lung Non-Small Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Exercise Intervention

Exercise Intervention

Exercise Intervention

Internet-Based Intervention

Study Details

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

Study ID

NCT07584239

Start date

Jul 15, 2026

Status verified date

May, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Biospecimen Collection

Undergo blood sample collection

Exercise Intervention

Complete exercises at home

Exercise Intervention

Receive portable exercise peddler and resistance bands

Exercise Intervention

Complete assigned exercises

Internet-Based Intervention

Receive access to the BeFitMe application

Physical Therapy

Complete physical therapy sessions

Relaxation Technique

Complete progressive muscle relaxation

Survey Administration

Ancillary studies

Text Message-Based Navigation Intervention

Receive motivational text messages

Primary outcome measure

  • Adherence (feasibility) [ Time Frame: At 12 week follow up session ]
  • Retention (feasibility) [ Time Frame: Up to 6 months post recruitment ]

Central Contacts and Locations

Central contacts

The Ohio State University Comprehensive Cancer Center

800-293-5066OSUCCCClinicaltrials@osumc.edu

Locations

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Carolyn J. Presley, MD

614-293-6453carolyn.presley@osumc.edu

Principal Investigator:

Carolyn J. Presley, MD

More Information

Sponsor

Ohio State University Comprehensive Cancer Center

Last update posted

May 26, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center on 2026-05-26.