Clinical trial NCT03115398: A Simple Walking Program to Enhance Concurrent Chemoradiotherapy Delivery
Official title: A Simple Walking Program to Enhance Concurrent Chemoradiotherapy Delivery: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Cancer
Head and Neck Cancer
Lung Cancer
Gastrointestinal Cancer
Cervical Cancer
Keywords: Fitness Tracker
Activity Monitoring
Chemotherapy
Radiation Therapy
Chemoradiotherapy
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
First posted: 2017-04-14
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Number of Missed Scheduled Radiotherapy Treatments
timeFrame: During chemoradiotherapy (an average of 6 weeks)
Secondary outcomes:
measure: Daily Step Counts
timeFrame: During chemoradiotherapy and over the following 4 weeks (an average of 10 weeks)
measure: Treatment-related Toxicities
timeFrame: During chemoradiotherapy and over the following 4 weeks (an average of 10 weeks)
measure: Patient-reported Quality of Life Scores
timeFrame: During chemoradiotherapy and over the following 4 weeks (an average of 10 weeks)
measure: Number of Emergency Room Visits
timeFrame: During chemoradiotherapy and over the following 4 weeks (an average of 10 weeks)
measure: Number of Hospitalizations
timeFrame: During chemoradiotherapy and over the following 4 weeks (an average of 10 weeks)
measure: Modified Glasgow Prognostic Scores
timeFrame: During chemoradiotherapy and over the following 4 weeks (an average of 10 weeks)
measure: Disease Progression or Recurrence
timeFrame: Through study completion, an average of 1 year
measure: Survival Status
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Nitin Ohri, MD
role: PRINCIPAL_INVESTIGATOR
References: