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Completed

NCT Number: NCT03115398

A Simple Walking Program to Enhance Concurrent Chemoradiotherapy Delivery

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.

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Key information

Conditions

Brain Cancer Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Cervical Cancer Digestive System Diseases Digestive System Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Head and Neck Cancer Head and Neck Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montefiore Medical Center

The Bronx, New York, 10467, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pedometer-based Walking Program

Behavioral

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Apr 14, 2017
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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