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This study is designed to evaluate whether a precision exercise regimen is feasible to implement within cancer populations, specifically stage II-III primary lung cancer patients receiving multimodal therapy, and delivered through telehealth.
This is a pilot study evaluating the feasibility of the Precision Exercise Regimen for Cancer Care (PERCC) intervention in stage II and stage III Non-Small Cell Lung Cancer (NSCLC) patients receiving multimodal therapy at the Huntsman Cancer Institute (HCI) at the University of Utah. Eligible patients will begin the intervention at the pre-treatment clinic visit and continue until approximately two months post-surgery.
The PERCC intervention is a virtually supervised home-based exercise program. Participants will engage in exercise starting at least two weeks before receiving their first neoadjuvant treatment for lung cancer and continuing until two months after receiving surgical treatment. The exercise modes will include basic transfer and calisthenics mobility, aerobic, and resistance exercises and will be performed in various postures (supine, sitting, standing, and walking) with variable challenges (level walking, bending, inclines, steps, and squatting).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Precision Exercise Regimen for Cancer Care (PERCC) | Experimental | Participants will engage in PERCC starting at least two weeks prior to receiving their first neoadjuvant treatment for lung cancer and continuing until two months after receiving surgical treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Precision Exercise Regimen for Cancer Care (PERCC) | Other | PERCC has exercise modes including basic transfer and calisthenics mobility, aerobic, and resistance exercises, and will be performed in various postures (supine, sitting, standing, and walking) with variable challenges (level walking, bending, inclines, steps, and squatting). Each participant will complete one supervised, home-based exercise training session per week, delivered through telehealth, that will focus on the resistance exercise prescription. Other unsupervised exercise training sessions will focus on the aerobic exercise prescription and will be completed individually |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility - Recruitment and Retention | Feasibility of the PERCC intervention will be evaluated by our ability to recruit and retain the needed number of patients with 80% exercise intervention attendance. | up to two months post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility - Safety | The feasibility of the PERCC intervention will be evaluated based on participant safety. This outcome measure will assess the safety and tolerability of the study treatment. The severity of AEs will be assessed using CTCAE v5.0 criteria, a 1-5 scale with higher numbers indicating greater severity. Grade 1 indicates "mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated" and Grade 5 indicates "death related to AE". Subjects will be monitored for adverse events from the start of treatment until two months post-surgery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thomas Varghese, MD, MS, MBA, FACS | Contact | 801-581-5311 | thomas.varghese@hsc.utah.edu | |
| Cornelia Ulrich, MS, PhD | Contact | 801-213-5716 | neli.ulrich@hci.utah.edu |
| Name | Affiliation | Role |
|---|---|---|
| Cornelia Ulrich, MS, PhD | Huntsman Cancer Institute/ University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Medical Branch at Galveston | Recruiting | Galveston | Texas | 77555 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26742998 | Background | Siegel RL, Miller KD, Jemal A. Cancer statistics, 2016. CA Cancer J Clin. 2016 Jan-Feb;66(1):7-30. doi: 10.3322/caac.21332. Epub 2016 Jan 7. | |
| 31805526 | Background | Ettinger DS, Wood DE, Aggarwal C, Aisner DL, Akerley W, Bauman JR, Bharat A, Bruno DS, Chang JY, Chirieac LR, D'Amico TA, Dilling TJ, Dobelbower M, Gettinger S, Govindan R, Gubens MA, Hennon M, Horn L, Lackner RP, Lanuti M, Leal TA, Lin J, Loo BW Jr, Martins RG, Otterson GA, Patel SP, Reckamp KL, Riely GJ, Schild SE, Shapiro TA, Stevenson J, Swanson SJ, Tauer KW, Yang SC, Gregory K; OCN; Hughes M. NCCN Guidelines Insights: Non-Small Cell Lung Cancer, Version 1.2020. J Natl Compr Canc Netw. 2019 Dec;17(12):1464-1472. doi: 10.6004/jnccn.2019.0059. |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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|
| up to two months post-surgery |
| Huntsman Cancer Institute | Recruiting | Salt Lake City | Utah | 84112 | United States |
|
| 35469182 | Background | Tchelebi LT, Shen B, Wang M, Potters L, Herman J, Boffa D, Segel JE, Park HS, Zaorsky NG. Nonadherence to Multimodality Cancer Treatment Guidelines in the United States. Adv Radiat Oncol. 2022 Mar 8;7(5):100938. doi: 10.1016/j.adro.2022.100938. eCollection 2022 Sep-Oct. |
| 27720827 | Background | Gao SJ, Corso CD, Wang EH, Blasberg JD, Detterbeck FC, Boffa DJ, Decker RH, Kim AW. Timing of Surgery after Neoadjuvant Chemoradiation in Locally Advanced Non-Small Cell Lung Cancer. J Thorac Oncol. 2017 Feb;12(2):314-322. doi: 10.1016/j.jtho.2016.09.122. Epub 2016 Oct 5. |
| 33148535 | Background | Hanna TP, King WD, Thibodeau S, Jalink M, Paulin GA, Harvey-Jones E, O'Sullivan DE, Booth CM, Sullivan R, Aggarwal A. Mortality due to cancer treatment delay: systematic review and meta-analysis. BMJ. 2020 Nov 4;371:m4087. doi: 10.1136/bmj.m4087. |
| 28449527 | Background | Yalman D. Invited Editorial on "the timing of surgery after neoadjuvant chemoradiation in locally advanced non-small cell lung cancer". J Thorac Dis. 2017 Mar;9(3):E299-E300. doi: 10.21037/jtd.2017.02.98. No abstract available. |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |