PILOT for The Precision Exercise Regimen for Cancer Care (PERCC) Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Utah
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Precision Exercise Regimen for Cancer Care (PERCC)
Other interventionPERCC 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
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Precision Exercise Regimen for Cancer Care (PERCC)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
up to two months post-surgerySecondary outcomes
1
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.
Time frame
up to two months post-surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov