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

Dartmouth-Hitchcock Medical Center4 enrolled

Overview

The purpose of this study is to conduct a pilot randomized controlled trial (RCT) evaluating the feasibility and potential effectiveness of a remotely supervised exercise program (REM) in promoting adherence to an exercise prescription before and during chemoradiation.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Lung Cancer

Interventions

Remotely Supervised Exercise (REM)BEHAVIORAL

REM is designed to follow in the tradition of stepped care behavioral interventions. As such, participants who are successfully engaging in the prescribed exercise are provided minimal and automated encouragement and praise. Participants who demonstrate less adherence are given interventions that are tailored in content and intensity, depending on the level of success and the nature of the barriers to success

Unsupervised Exercise (UNSUP)BEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Dartmouth Hitchcock Medical Center

Hanover, New Hampshire, United States

Outcomes

Primary Outcomes

Recruitment and retention statistics

Number of participants enrolled/number of patients eligible; Number completing all data collection/Number enrolled; Number adhering to randomization/number enrolled; Number withdrawn/number enrolled