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

Official title

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

Overview

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.

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.

Interventions

• Procedure Biospecimen Collection
  Undergo blood sample collection
• 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
• Procedure Physical Therapy
  Complete physical therapy sessions
• Behavioral Relaxation Technique
  Complete progressive muscle relaxation
• Other Survey Administration
  Ancillary studies
• Other Text Message-Based Navigation Intervention
  Receive motivational text messages

Primary outcome measures

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

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• Ohio State University Comprehensive Cancer Center — Columbus

Identifiers

NCT: NCT07584239 · OSU-24288 · NCI-2026-02426 · OSU-24288

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗