A Remotely Supervised Exercise Program for Lung Cancer Patients Undergoing Chemoradiation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lung Cancer
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Recruitment and retention statistics
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Detailed Description
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).
Investigators
Kathleen Lyons
Scientist, Psychiatry Research
Dartmouth-Hitchcock Medical Center
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Recruitment and retention statistics
Time Frame: Time 3, One month after completing chemoradiation
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
Secondary Outcomes
- 6-minute walk test(Time 3, One month after completing chemoradiation)
- Five times sit-to-stand test(Time 3, One month after completing chemoradiation)
- Minutes spent in exercise(Time 3, One month after completing chemoradiation)
- Timed up-and-go test(Time 3, One month after completing chemoradiation)
- Forced expiratory volume in 1 second(Time 3, One month after completing chemoradiation)
- Diffusion capacity(Time 3, One month after completing chemoradiation)
- Physical Function Scale of the Patient Reported Outcomes Measurement information System (PROMIS)(Time 3, One month after completing chemoradiation)
- Pittsburgh Sleep Quality Index(Time 3, One month after completing chemoradiation)
- Dose reductions(Time 3, One month after completing chemoradiation)
- Grip strength(Time 3, one month after completing chemoradiation)
- Forced vital capacity(Time 3, One month after completing chemoradiation)
- Functional Assessment of Cancer Therapy-fatigue scale(Time 3, One month after completing chemoradiation)