By utilizing fitness trackers, this study aims to demonstrate that a simple walking program improves patients' ability to tolerate curative concurrent chemoradiotherapy without treatment interruption.
Patients will be given a commercially available fitness tracker to wear continuously throughout the course of the study. Per this study's inclusion criteria, all patients will be treated with concurrent chemoradiotherapy for a malignancy of the brain, head and neck region, lung, gastrointestinal tract, or cervix. Patients will be randomized to one of two arms: an experimental arm, where they will be instructed to meet a daily, customized step count goal, or a control arm where they will wear activity trackers but be given no specific instructions to increase their activity levels. Patients in the experimental arm who fail to meet their step count goal for three consecutive days will be contacted by a study coordinator and reminded to try to meet the activity goals. If the patient reports that his or her activity is limited by treatment-related toxicities, the patient's treating physicians will be notified to ensure that supportive care needs are being met. With such a program, this study aims to demonstrate the potential to improve patients' ability to tolerate curative concurrent chemoradiotherapy without treatment interruption.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
166
Patients will be instructed to meet the daily step count goal displayed on their fitness tracker. If goal is not being met, study team will intervene and reinforce the importance of meeting this goal. Intervention will include a conversation with the patient, led by a study coordinator, to identify any challenges present in meeting the prescribed goal. Solutions to such challenges may be offered by the coordinator or necessary provider, such as a dietitian, when applicable.
Montefiore Medical Center
The Bronx, New York, United States
Number of Missed Scheduled Radiotherapy Treatments
The primary endpoint of this study is missing two or more scheduled external beam radiotherapy treatments. Treatments that are cancelled due to national holidays, inclement weather, or machine issues will not count towards this endpoint.
Time frame: During chemoradiotherapy (an average of 6 weeks)
Daily Step Counts
Step counts will be recorded and measured daily from patients' fitness trackers.
Time frame: During chemoradiotherapy and over the following 4 weeks (an average of 10 weeks)
Treatment-related Toxicities
Toxicities will be evaluated each week and scored using CTCAE version 4.03.
Time frame: During chemoradiotherapy and over the following 4 weeks (an average of 10 weeks)
Patient-reported Quality of Life Scores
Measured weekly using the EORTC QLC-C30.
Time frame: During chemoradiotherapy and over the following 4 weeks (an average of 10 weeks)
Number of Emergency Room Visits
Using the EMR, a record will be kept indicating the number of times each patient visits the emergency room.
Time frame: During chemoradiotherapy and over the following 4 weeks (an average of 10 weeks)
Number of Hospitalizations
Using the EMR, a record will be kept indicating the number of times each patient is hospitalized.
Time frame: During chemoradiotherapy and over the following 4 weeks (an average of 10 weeks)
Modified Glasgow Prognostic Scores
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Scores will be calculated based on serum albumin and C-reactive protein levels.
Time frame: During chemoradiotherapy and over the following 4 weeks (an average of 10 weeks)
Disease Progression or Recurrence
Disease progression or recurrence, to be scored by treating physicians based on available clinical and imaging data
Time frame: Through study completion, an average of 1 year
Survival Status
Survival data will be kept for all patients on study throughout treatment and follow-ups.
Time frame: Through study completion, an average of 1 year