NSCLC Stage II, NSCLC, Stage III
Conditions
Brief summary
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.
Detailed description
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).
Interventions
OTHERPrecision 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 sessions will focus on the aerobic exercise prescription and will be completed individually
Sponsors
University of Utah
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility - Recruitment and Retention | up to two months post-surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility - Safety | up to two months post-surgery | 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. |
Countries
United States
Contacts
CONTACTThomas Varghese, MD, MS, MBA, FACS
CONTACTCornelia Ulrich, MS, PhD
PRINCIPAL_INVESTIGATORCornelia Ulrich, MS, PhD
Huntsman Cancer Institute/ University of Utah
Outcome results
None listed