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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOhio State University Comprehensive Cancer Center

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Exercise Intervention

    Other intervention

    Complete exercises at home

  • Exercise Intervention

    Other intervention

    Receive portable exercise peddler and resistance bands

  • Exercise Intervention

    Other intervention

    Complete assigned exercises

  • Internet-Based Intervention

    Other intervention

    Receive access to the BeFitMe application

  • Physical Therapy

    Procedure/Surgery

    Complete physical therapy sessions

  • Relaxation Technique

    Behavioral

    Complete progressive muscle relaxation

  • Survey Administration

    Other intervention

    Ancillary studies

  • Text Message-Based Navigation Intervention

    Other intervention

    Receive motivational text messages

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Arm I (ROAR-LCS)Experimental treatment 5 interventions
Group B: Arm II (BeFitMe)Experimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
At 12 week follow up session
2

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.

Time frame
Up to 6 months post recruitment

Secondary outcomes

Other outcomes

Sponsors and contacts

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