A Remotely Supervised Exercise Program for Lung Cancer Patients Undergoing Chemoradiation (REM)

The research team adopts an overtly pragmatic approach where our design choices are made to
enhance external validity and create a parsimonious intervention that can be integrated into
busy clinical practices. This is a pilot study and is not designed to definitively provide
evidence for a treatment effect, but rather to establish feasibility and to optimize the
intervention and study procedures in preparation for a larger trial. We will conduct a pilot
RCT comparing a remotely supervised exercise program (REM) to an unsupervised exercise
program (UNSUP). Data will be collected upon enrollment (T0; at least 2 weeks prior to
beginning chemoradiation), immediately prior to chemoradiation (T1), immediately
post-chemoradiation (T2) and 1-month post-chemoradiation (T3).

Inclusion Criteria:

- Are over the age of 18 and diagnosed with Stage IIa to IIIb lung cancer;

- Definitive treatment with chemoradiation with weekly carboplatin and paclitaxel
concurrent with radiation is planned to begin in no less than 2 weeks;

- Have an Apple or Android device with capacity to install a fitness device app and
access to either WiFi or cellular service;

- Are English-speaking and able to provide voluntary, written consent;

- Able to tolerate chemoradiation as indicated by Zubrod/ECOG Performance Status 0-1;
CBC/differential obtained within 14 days prior to registration on study, with adequate
bone marrow function defined as follows: Absolute neutrophil count (ANC) ≥ 1,500
cells/mm3; Platelets ≥ 100,000 cells/mm3; Hemoglobin ≥ 8.0 g/dl;Adequate renal
function within 14 days prior to registration, defined as creatinine clearance must be
at least 35 ml/min; Adequate hepatic function within 14 days prior to registration,
defined as total bilirubin ≤ 1.5 x upper limit of normal (ULN) for the institution and
ALT, AST, and alkaline phosphatase ≤ 2.5 x ULN for the institution; No prior thoracic
radiation therapy;

Exclusion Criteria:

- Life expectancy of < 12 months or are receiving hospice services;

- Psychiatric diagnosis that would require significant study modification to meet their
needs such as uncontrolled severe mental illness, substance abuse, or active suicidal
ideation;

- Exhibit American College of Sports Medicine contraindications to exercise which
include a resting heart rate of >120bpm, blood pressure >180/100mmHg or unstable
angina 40 or musculoskeletal issue preventing exercise;

- Are unable to walk 100 meters. According to our current standard of care, those
participants will be referred to physical therapy for evaluation and treatment and
will be excluded from the study as unsupervised exercise would not be safe;

- Less than 2 weeks to the beginning of chemoradiation;

- Physician discretion;

- Are unable to walk or to complete the 6-minute walk test. According to our current
standard of care, those participants will be referred to physical therapy for
evaluation and treatment and will be excluded from the study as unsupervised exercise
would not be safe.