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

21. mai 2026 oppdatert av: Carolyn Presley, Ohio State University Comprehensive Cancer Center

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

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

30

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • Ohio
      • Columbus, Ohio, Forente stater, 43210
        • Rekruttering
        • Ohio State University Comprehensive Cancer Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Carolyn J. Presley, MD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Fremgangsmåte: Bioprøvesamling
Gjennomgå blodprøvetaking
Andre navn:
  • Biologisk prøvesamling
  • Bioprøve samlet
  • Prøvesamling
Annen: Undersøkelsesadministrasjon
Hjelpestudier
Annen: Exercise Intervention
Complete exercises at home
Annen: Exercise Intervention
Receive portable exercise peddler and resistance bands
Annen: Exercise Intervention
Complete assigned exercises
Fremgangsmåte: Physical Therapy
Complete physical therapy sessions
Andre navn:
  • PT
  • Fysiatrisk prosedyre
  • Fysisk medisin prosedyre
  • Fysioterapi
  • Fysioterapiprosedyre
  • Fysioterapi prosedyre
Atferdsmessig: Relaxation Technique
Complete progressive muscle relaxation
Eksperimentell: 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.
Fremgangsmåte: Bioprøvesamling
Gjennomgå blodprøvetaking
Andre navn:
  • Biologisk prøvesamling
  • Bioprøve samlet
  • Prøvesamling
Annen: Undersøkelsesadministrasjon
Hjelpestudier
Annen: Exercise Intervention
Complete exercises at home
Annen: Exercise Intervention
Receive portable exercise peddler and resistance bands
Annen: Exercise Intervention
Complete assigned exercises
Annen: Internet-Based Intervention
Receive access to the BeFitMe application
Annen: Text Message-Based Navigation Intervention
Receive motivational text messages
Andre navn:
  • Automatisert tekstmeldingsbasert navigering
  • Tekstmeldingsbasert navigering

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Adherence (feasibility)
Tidsramme: At 12 week follow up session
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)
Tidsramme: Up to 6 months post recruitment
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Ohio State University Comprehensive Cancer Center

Etterforskere

  • Hovedetterforsker: Carolyn J Presley, MD, Ohio State University Comprehensive Cancer Center

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

15. juli 2026

Primær fullføring (Antatt)

31. desember 2026

Studiet fullført (Antatt)

31. desember 2026

Datoer for studieregistrering

Først innsendt

7. mai 2026

Først innsendt som oppfylte QC-kriteriene

7. mai 2026

Først lagt ut (Faktiske)

13. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

26. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • OSU-24288 (Annen identifikator: Ohio State University Comprehensive Cancer Center)
  • NCI-2026-02426 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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