About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Parallel
Treatments tested in this trial
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Exercise Intervention
Other interventionComplete exercises at home
Exercise Intervention
Other interventionReceive portable exercise peddler and resistance bands
Exercise Intervention
Other interventionComplete assigned exercises
Internet-Based Intervention
Other interventionReceive access to the BeFitMe application
Physical Therapy
Procedure/SurgeryComplete physical therapy sessions
Relaxation Technique
BehavioralComplete progressive muscle relaxation
Survey Administration
Other interventionAncillary studies
Text Message-Based Navigation Intervention
Other interventionReceive motivational text messages
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
Sponsors and contacts
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