A Simple Walking Program to Enhance Concurrent Chemoradiotherapy Delivery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Lung Cancer, Brain Cancer, Head and Neck Cancer, Gastrointestinal Cancer, Cervical Cancer

Intervention / Treatment
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* Behavioral: Pedometer-based Walking Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 ECOG performance status 0-2 Able to ambulate independently (without the assistance of a cane or walker) Diagnosis of invasive malignancy of the brain, head and neck region, lung, gastrointestinal tract, or uterine cervix Planned treatment with fractionated (≥15 treatments) external beam radiotherapy with concurrent chemotherapy (or cetuximab) with curative intent (including preoperative or postoperative treatment) Women of childbearing potential must: Have a negative serum or urine pregnancy test within 72 hours prior to the start of study therapy Agree to utilize an adequate method of contraception throughout treatment and for at least 4 weeks after study therapy is completed Be advised of the importance of avoiding pregnancy during trial participation and the potential risks of an unintentional pregnancy. All patients must sign study specific informed consent prior to study entry.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Activity Monitoring with Routine Care<br>Subjects randomized to the control arm will wear activity trackers but will have no specific instructions to increase their activity levels. | |
| Experimental: Pedometer-based Walking Program<br>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. | Behavioral: Pedometer-based Walking Program<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily Step Counts | Step counts will be recorded and measured daily from patients' fitness trackers. | 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. | 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. | 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. | 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. | During chemoradiotherapy and over the following 4 weeks (an average of 10 weeks) | 
| Modified Glasgow Prognostic Scores | Scores will be calculated based on serum albumin and C-reactive protein levels. | 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 | 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. | Through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fitness Tracker, Activity Monitoring, Chemotherapy, Radiation Therapy, Chemoradiotherapy