A Simple Walking Program to Enhance Concurrent Chemoradiotherapy Delivery

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03115398
• Other study ID #: 2017-7472
• Status: Completed
• Phase: N/A
• Start date: February 16, 2017
• Est. completion date: March 3, 2021

Study information

• Verified date: March 2021
• Source: Albert Einstein College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: March 3, 2021
• Est. primary completion date: March 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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