NCT03115398|CompletedDMC
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Sponsor study identifier
interventional
166
1 country
1
Study Start
February 16, 2017
Actual (reported)Primary Completion
March 3, 2020
Actual (reported)Study Completion
March 3, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 3, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 16, 2017
Actual (reported)March 30, 2017
Actual (reported)April 14, 2017
Actual (reported)March 3, 2020
Actual (reported)March 3, 2021
Actual (reported)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.
During chemoradiotherapy (an average of 6 weeks)
Daily Step Counts
During chemoradiotherapy and over the following 4 weeks (an average of 10 weeks)
Treatment-related Toxicities
During chemoradiotherapy and over the following 4 weeks (an average of 10 weeks)
Subjects randomized to the control arm will wear activity trackers but will have no specific instructions to increase their activity levels.
Subjects randomized to the experimental arm will be instructed to meet the customized daily step count goals that are displayed on their fitness trackers. Patients 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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Montefiore Medical Center
The Bronx, New York, 10467, United States
Nitin Ohri, MD
Albert Einstein College of Medicine
166 participants (actual enrollment reported by the registry).
First Submitted
March 30, 2017
First Posted
April 14, 2017
Study Start
February 16, 2017
Actual (reported)DMH-Based Plan Evaluation and Inverse Optimization in Radiotherapy
Patient-reported Quality of Life Scores
During chemoradiotherapy and over the following 4 weeks (an average of 10 weeks)
Number of Emergency Room Visits
During chemoradiotherapy and over the following 4 weeks (an average of 10 weeks)
Number of Hospitalizations
During chemoradiotherapy and over the following 4 weeks (an average of 10 weeks)
Contact the study team to confirm eligibility.
Primary Completion
March 3, 2020
Actual (reported)Study Completion
March 3, 2021
Actual (reported)Last Updated
April 13, 2026
Record last verified: 2026-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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