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A Simple Walking Program to Enhance Concurrent Chemoradiotherapy Delivery

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Disease Information

Descriptive Information
Brief Title † A Simple Walking Program to Enhance Concurrent Chemoradiotherapy Delivery
Official Title † A Simple Walking Program to Enhance Concurrent Chemoradiotherapy Delivery: A Randomized Trial
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 Phase N/A
Study Type † Interventional
Study Design †
Primary Outcome Measure † Number of Missed Scheduled Radiotherapy Treatments
Secondary Outcome Measure † Daily Step Counts
Condition † Brain Cancer Head and Neck Cancer Lung Cancer Gastrointestinal Cancer Cervical Cancer
Intervention † BehavioralPedometer-based Walking Program
Study Arms / Comparison Groups Activity Monitoring with Routine Care Subjects randomized to the control arm will wear activity trackers but will have no specific instructions to increase their activity levels. 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.
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Behavioral
Estimated Enrollment † 166
Start Date † February 16, 2017
Completion Date February 16, 2023
Primary Completion Date February 16, 2021
Eligibility Criteria † 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.
Gender All
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts †† Alyssa M Asaro, BA, 718 920 5636, aasaro@montefiore.org
Location Countries † United States
Administrative Information
NCT ID † NCT03115398
Organization ID 2017-7472
Secondary IDs ††
Responsible Party Principal Investigator
Study Sponsor † Albert Einstein College of Medicine, Inc.
Collaborators ††
Investigators † Principal Investigator: Nitin Ohri, MD, Albert Einstein College of Medicine, Inc.
Information Provided By
Verification Date April 2017
First Received Date † March 30, 2017
Last Updated Date April 11, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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