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.
Brief Title
A Simple Walking Program to Enhance Concurrent Chemoradiotherapy Delivery
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Brain Cancer
Head and Neck Cancer
Lung Cancer
Gastrointestinal Cancer
Cervical Cancer
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.
* 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.
Inclusion 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.
* 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
Gender Based
false
Keywords
Fitness Tracker
Activity Monitoring
Chemotherapy
Radiation Therapy
Chemoradiotherapy
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03115398
Org Class
Other
Org Full Name
Albert Einstein College of Medicine
Org Study Id
2017-7472
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Simple Walking Program to Enhance Concurrent Chemoradiotherapy Delivery: A Randomized Trial
Primary Outcomes
Outcome Description
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.
Outcome Measure
Number of Missed Scheduled Radiotherapy Treatments
Outcome Time Frame
During chemoradiotherapy (an average of 6 weeks)
Secondary Outcomes
Outcome Description
Step counts will be recorded and measured daily from patients' fitness trackers.
Outcome Time Frame
During chemoradiotherapy and over the following 4 weeks (an average of 10 weeks)
Outcome Measure
Daily Step Counts
Outcome Description
Toxicities will be evaluated each week and scored using CTCAE version 4.03.
Outcome Time Frame
During chemoradiotherapy and over the following 4 weeks (an average of 10 weeks)
Outcome Measure
Treatment-related Toxicities
Outcome Description
Measured weekly using the EORTC QLC-C30.
Outcome Time Frame
During chemoradiotherapy and over the following 4 weeks (an average of 10 weeks)
Outcome Measure
Patient-reported Quality of Life Scores
Outcome Description
Using the EMR, a record will be kept indicating the number of times each patient visits the emergency room.
Outcome Time Frame
During chemoradiotherapy and over the following 4 weeks (an average of 10 weeks)
Outcome Measure
Number of Emergency Room Visits
Outcome Description
Using the EMR, a record will be kept indicating the number of times each patient is hospitalized.
Outcome Time Frame
During chemoradiotherapy and over the following 4 weeks (an average of 10 weeks)
Outcome Measure
Number of Hospitalizations
Outcome Description
Scores will be calculated based on serum albumin and C-reactive protein levels.
Outcome Time Frame
During chemoradiotherapy and over the following 4 weeks (an average of 10 weeks)
Outcome Measure
Modified Glasgow Prognostic Scores
Outcome Description
Disease progression or recurrence, to be scored by treating physicians based on available clinical and imaging data
Outcome Time Frame
Through study completion, an average of 1 year
Outcome Measure
Disease Progression or Recurrence
Outcome Description
Survival data will be kept for all patients on study throughout treatment and follow-ups.
Outcome Time Frame
Through study completion, an average of 1 year
Outcome Measure
Survival Status
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Nitin Ohri
Investigator Email
nitin.ohri@einsteinmed.org
Investigator Phone