PILOT for The Precision Exercise Regimen for Cancer Care (PERCC) Study

Обзор

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.

Подробное описание

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).

Вмешательства

• Другое Precision Exercise Regimen for Cancer Care (PERCC)
  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 sess

Первичные конечные точки

• Feasibility - Recruitment and Retention [Срок оценки: up to two months post-surgery]

Вторичные конечные точки (1)

• Feasibility - Safety [Срок оценки: up to two months post-surgery]

Критерии участия

Критерии включения

• Ages 18 and older at time of diagnosis
• Patient diagnosed with stage II and III non-small cell lung cancer (NSCLC)
• Patient receives either neoadjuvant chemotherapy or immunotherapy and surgery
• Patient able to follow direction and complete questionnaires in English or Spanish
• Patient agrees to complete the PERCC intervention

Критерии исключения

• Morbidly obese (BMI >40 kg/m2 ) or anorexic (BMI <17.5 kg/m2 )
• Abnormalities on screening physical exam per study physicians or physical therapist to contraindicate participation in exercise program compliance
• Alcohol or drug abuse, significant mental or emotional problems that would interfere with compliance (assessed by NCCN Distress Thermometer)
• Patient scheduled to receive single modality cancer treatment (unimodal therapy), scheduled to begin treatment within 2 weeks of the pre-treatment clinic visit, or for whom treatment has already started

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 2 центра

• University of Texas Medical Branch at Galveston — Galveston
• Huntsman Cancer Institute — Salt Lake City

Публикации

• 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. PMID 26742998
• 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. PMID 31805526
• 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. PMID 35469182
• 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. PMID 27720827
• 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. PMID 33148535
• 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. PMID 28449527

Идентификаторы

NCT: NCT06945484 · HCI162865

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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