Prehabilitation Physical Therapy and Relaxation Intervention Program to Promote Resiliency and Operative Success Among Adults Receiving Lung Cancer Surgery, ROAR-LCS Trial
LiveWellLung: A Prehabilitation Intervention Program to Promote Resiliency and Operative Success Among Adults Receiving Lung Cancer Surgery (ROAR-LCS) With Biospecimen Collection
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: The Ohio State University Comprehensive Cancer Center
- Puhelinnumero: 800-293-5066
- Sähköposti: OSUCCCClinicaltrials@osumc.edu
Opiskelupaikat
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Ohio
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Columbus, Ohio, Yhdysvallat, 43210
- Rekrytointi
- Ohio State University Comprehensive Cancer Center
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Ottaa yhteyttä:
- Carolyn J. Presley, MD
- Puhelinnumero: 614-293-6453
- Sähköposti: carolyn.presley@osumc.edu
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Päätutkija:
- Carolyn J. Presley, MD
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-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
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)
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Tukevaa hoitoa
- Jako: Ei satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 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.
|
Suorita verinäytteiden otto
Muut nimet:
Apututkimukset
Complete exercises at home
Receive portable exercise peddler and resistance bands
Complete assigned exercises
Complete physical therapy sessions
Muut nimet:
Complete progressive muscle relaxation
|
|
Kokeellinen: 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.
|
Suorita verinäytteiden otto
Muut nimet:
Apututkimukset
Complete exercises at home
Receive portable exercise peddler and resistance bands
Complete assigned exercises
Receive access to the BeFitMe application
Receive motivational text messages
Muut nimet:
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Adherence (feasibility)
Aikaikkuna: At 12 week follow up session
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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.
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At 12 week follow up session
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Retention (feasibility)
Aikaikkuna: Up to 6 months post recruitment
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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.
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Up to 6 months post recruitment
|
Yhteistyökumppanit ja tutkijat
Tutkijat
- Päätutkija: Carolyn J Presley, MD, Ohio State University Comprehensive Cancer Center
Julkaisuja ja hyödyllisiä linkkejä
Hyödyllisiä linkkejä
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- OSU-24288 (Muu tunniste: Ohio State University Comprehensive Cancer Center)
- NCI-2026-02426 (Rekisterin tunniste: CTRP (Clinical Trial Reporting Program))
Lääke- ja laitetiedot, tutkimusasiakirjat
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