NCT03500393.
| Trial name or title | A Remotely Supervised Exercise Program for Lung Cancer Patients Undergoing Chemoradiation (REM) |
| Methods | Randomised controlled trial Setting: home‐based, United States of Americia Study duration: from at least two‐weeks prior to beginning chemoradiation to one‐month post‐chemoradiation. |
| Participants | Inclusion criteria: 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; 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; haemoglobin ≥ 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 (includes a resting heart rate of > 120 bpm, blood pressure > 180/100 mmHg or unstable angina 40 or musculoskeletal issue preventing exercise; are unable to walk 100 meters); less than 2 weeks to the beginning of chemoradiation; physician discretion; are unable to walk or to complete the 6‐minute walk test. |
| Interventions | Active comparator: Unsupervised Exercise (UNSUP). The control condition represents a minimalist intervention that could occur in any setting: 1) enthusiastic provision on an exercise prescription, and 2) provision of a fitness device (i.e. the Garmin VivioActive) that can help participants track their exercise engagement. Participants are instructed in how to use the device to track their adherence to the exercise prescription. Experimental: Remotely Supervised Exercise (REM) designed to function as an acceptance‐based health coaching intervention and will utilise theory‐based behaviour change techniques (i.e. goal setting/action planning, self‐monitoring, receiving feedback, and reviewing relevant goals in the light of feedback) to promote adoption and adherence to the exercise prescription. |
| Outcomes | Recruitment and retention statistics (number of participants enrolled/number of patients eligible; number completing all data collection/number enrolled; number adhering to randomisation/number enrolled; number withdrawn/number enrolled), minutes spent in exercise (collected from fitness device), functional capacity (6MWD), physical functioning (timed up‐and‐go test, five times sit‐to‐stand test), lung function (FEV1, DLCO, FVC), Physical Function Scale of the Patient Reported Outcomes Measurement information System, Pittsburgh Sleep Quality Index, Functional Assessment of Cancer Therapy‐fatigue scale, Dose reductions (determine the degree to which participants received the prescribed regimen of chemoradiation), grip strength (JAMAR Handheld Dynamometer). |
| Starting date | 22 June 2018 |
| Contact information | Kayla Fay: Kayla.A.Fay@hitchcock.org |
| Notes |
6MWD: Six‐minute walk distance 6MWT: Six‐minute walk test BMI: Body mass index bpm: Beats per minute CPET: Cardiopulmonary exercise test DLCO: Diffusing capacity of the lungs for carbon monoxide EORTC QLQC30: European Orgnisation for Research and Treatment of Cancer Core Quality of Life Questionnaire EORTC QLQ LC13: European Orgnisation for Research and Treatment of Cancer lung cancer‐specific questionnaire module
FEV1: Forced expiratory volume in one second FVC: Forced vital capacity HRQoL: Health‐related quality of life NSCLC: Non‐small cell lung cancer VO2peak: Peak oxygen uptake