A Simple Walking Program to Enhance Concurrent Chemoradiotherapy Delivery

NCT03115398 | Completed DMC

• 1 other identifier: 2017-7472
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Cancer; Head and Neck Cancer; Lung Cancer; Cervical Cancer; Gastrointestinal Cancer

Keywords

Fitness Tracker; Activity Monitoring; Chemotherapy; Radiation Therapy; Chemoradiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Daily Step Counts

  During chemoradiotherapy and over the following 4 weeks (an average of 10 weeks)

• Treatment-related Toxicities

  During chemoradiotherapy and over the following 4 weeks (an average of 10 weeks)

• Patient-reported Quality of Life Scores

  During chemoradiotherapy and over the following 4 weeks (an average of 10 weeks)

• Number of Emergency Room Visits

  During chemoradiotherapy and over the following 4 weeks (an average of 10 weeks)

• Number of Hospitalizations

  During chemoradiotherapy and over the following 4 weeks (an average of 10 weeks)

Study Arms (2)

Activity Monitoring with Routine Care

NO INTERVENTION

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

EXPERIMENTAL

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

Interventions

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.

Pedometer-based Walking Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Brain Neoplasms; Head and Neck Neoplasms; Lung Neoplasms; Gastrointestinal Neoplasms; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Nitin Ohri, MD

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2017
• First Posted: April 14, 2017
• Study Start: February 16, 2017
• Primary Completion: March 3, 2020
• Study Completion: March 3, 2021
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)