NCT03115398

A Simple Walking Program to Enhance Concurrent Chemoradiotherapy Delivery

A Simple Walking Program to Enhance Concurrent Chemoradiotherapy Delivery: A Randomized Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 166 (actual)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Brain Cancer
• Head and Neck Cancer
• Lung Cancer
• Gastrointestinal Cancer
• Cervical Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Pedometer-based Walking Program	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.

Timeline

• Start date: 2017-02-16
• Primary completion: 2020-03-03
• Completion: 2021-03-03
• First posted: 2017-04-14
• Last updated: 2026-04-13

Locations

1 site across 1 country: United States