A Simple Walking Program to Enhance Concurrent Chemoradiotherapy Delivery

Not Applicable

Completed

• Conditions: Brain Cancer; Gastrointestinal Cancer; Head and Neck Cancer; Lung Cancer; Cervical Cancer
• Interventions: Behavioral: Pedometer-based Walking Program

• Registration Number: NCT03115398
• Lead Sponsor: Albert Einstein College of Medicine

Brief 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.

Study Timeline

• Study Start: 2017-02-16
• Study First Submitted: 2017-03-30
• Study First Submitted QC: 2017-04-11
• Study First Posted: 2017-04-14
• Primary Completion: 2020-03-03
• Status Verified: 2021-03
• Study Completion: 2021-03-03
• Last Update Submitted: 2021-03-23
• Last Update Posted: 2021-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 166

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pedometer-based Walking Program	Pedometer-based Walking Program	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.

Primary Outcome Measures

Name	Time	Method
Number of Missed Scheduled Radiotherapy Treatments	During chemoradiotherapy (an average of 6 weeks)	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.

Secondary Outcome Measures

Name	Time	Method
Daily Step Counts	During chemoradiotherapy and over the following 4 weeks (an average of 10 weeks)	Step counts will be recorded and measured daily from patients' fitness trackers.
Modified Glasgow Prognostic Scores	During chemoradiotherapy and over the following 4 weeks (an average of 10 weeks)	Scores will be calculated based on serum albumin and C-reactive protein levels.
Patient-reported Quality of Life Scores	During chemoradiotherapy and over the following 4 weeks (an average of 10 weeks)	Measured weekly using the EORTC QLC-C30.
Number of Hospitalizations	During chemoradiotherapy and over the following 4 weeks (an average of 10 weeks)	Using the EMR, a record will be kept indicating the number of times each patient is hospitalized.
Treatment-related Toxicities	During chemoradiotherapy and over the following 4 weeks (an average of 10 weeks)	Toxicities will be evaluated each week and scored using CTCAE version 4.03.
Number of Emergency Room Visits	During chemoradiotherapy and over the following 4 weeks (an average of 10 weeks)	Using the EMR, a record will be kept indicating the number of times each patient visits the emergency room.
Survival Status	Through study completion, an average of 1 year	Survival data will be kept for all patients on study throughout treatment and follow-ups.
Disease Progression or Recurrence	Through study completion, an average of 1 year	Disease progression or recurrence, to be scored by treating physicians based on available clinical and imaging data

Trial Locations

Locations (1)

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States