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A Simple Walking Program to Enhance Concurrent Chemoradiotherapy Delivery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03115398
Recruitment Status : Active, not recruiting
First Posted : April 14, 2017
Last Update Posted : May 12, 2020
Sponsor:
Information provided by (Responsible Party):
Nitin Ohri, Albert Einstein College of Medicine

Study Description
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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.

Condition or disease Intervention/treatment Phase
Brain Cancer Head and Neck Cancer Lung Cancer Gastrointestinal Cancer Cervical Cancer Behavioral: Pedometer-based Walking Program Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Simple Walking Program to Enhance Concurrent Chemoradiotherapy Delivery: A Randomized Trial
Actual Study Start Date : February 16, 2017
Actual Primary Completion Date : March 3, 2020
Estimated Study Completion Date : March 3, 2021
Arms and Interventions
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Arm Intervention/treatment
No Intervention: 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.
Experimental: 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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Number of Missed Scheduled Radiotherapy Treatments [ Time Frame: 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 :
  1. Daily Step Counts [ Time Frame: 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.

  2. Treatment-related Toxicities [ Time Frame: 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.

  3. Patient-reported Quality of Life Scores [ Time Frame: During chemoradiotherapy and over the following 4 weeks (an average of 10 weeks) ]
    Measured weekly using the EORTC QLC-C30.

  4. Number of Emergency Room Visits [ Time Frame: 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.

  5. Number of Hospitalizations [ Time Frame: 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.

  6. Modified Glasgow Prognostic Scores [ Time Frame: 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.

  7. Disease Progression or Recurrence [ Time Frame: 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

  8. Survival Status [ Time Frame: Through study completion, an average of 1 year ]
    Survival data will be kept for all patients on study throughout treatment and follow-ups.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03115398


Locations
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United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Albert Einstein College of Medicine
Investigators
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Principal Investigator: Nitin Ohri, MD Albert Einstein College of Medicine
More Information
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Responsible Party: Nitin Ohri, Assistant Professor, Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT03115398    
Other Study ID Numbers: 2017-7472
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: May 12, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nitin Ohri, Albert Einstein College of Medicine:
Fitness Tracker
Activity Monitoring
Chemotherapy
Radiation Therapy
Chemoradiotherapy
Additional relevant MeSH terms:
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Gastrointestinal Neoplasms
Brain Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Neoplasms
Digestive System Diseases
 Gastrointestinal Diseases
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases