Brain CancerNCT03115398
A Simple Walking Program to Enhance Concurrent Chemoradiotherapy Delivery
A study testing Pedometer-based Walking Program in people with Brain Cancer and Head and Neck Cancer, run by Montefiore Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Cancer, Head and Neck Cancer, Lung Cancer
- What is being tested?
- Pedometer-based Walking Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Feb 2017to 3 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 10Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: A Simple Walking Program to Enhance Concurrent Chemoradiotherapy Delivery: A Randomized Trial
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.
Read the 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.
- Being tested
- Pedometer-based Walking Program
- Keywords
- Fitness Tracker, Activity Monitoring, Chemotherapy, Radiation Therapy, Chemoradiotherapy
- Medical subject headings
- Brain Neoplasms, Head and Neck Neoplasms, Lung Neoplasms, Gastrointestinal Neoplasms, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pedometer-based Walking ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Pedometer-based Walking Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During chemoradiotherapy (an average of 6 weeks)
Secondary outcomes (8)
Daily Step Counts
Step counts will be recorded and measured daily from patients' fitness trackers.
Measured: During chemoradiotherapy and over the following 4 weeks (an average of 10 weeks)
Treatment-related Toxicities
Toxicities will be evaluated each week and scored using CTCAE version 4.03.
Measured: During chemoradiotherapy and over the following 4 weeks (an average of 10 weeks)
Patient-reported Quality of Life Scores
Measured weekly using the EORTC QLC-C30.
Measured: During chemoradiotherapy and over the following 4 weeks (an average of 10 weeks)
Number of Emergency Room Visits
Using the EMR, a record will be kept indicating the number of times each patient visits the emergency room.
Measured: During chemoradiotherapy and over the following 4 weeks (an average of 10 weeks)
Number of Hospitalizations
Using the EMR, a record will be kept indicating the number of times each patient is hospitalized.
Measured: During chemoradiotherapy and over the following 4 weeks (an average of 10 weeks)
Modified Glasgow Prognostic Scores
Scores will be calculated based on serum albumin and C-reactive protein levels.
Measured: During chemoradiotherapy and over the following 4 weeks (an average of 10 weeks)
Disease Progression or Recurrence
Disease progression or recurrence, to be scored by treating physicians based on available clinical and imaging data
Measured: Through study completion, an average of 1 year
Survival Status
Survival data will be kept for all patients on study throughout treatment and follow-ups.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start16 Feb 2017
- Primary completion3 Mar 2020
- Study completion3 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nitin Ohri, MD, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03115398
- Sponsor's protocol ID
- 2017-7472
- Status last verified
- Apr 2026
- First submitted
- 30 Mar 2017
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Simple Walking Program to Enhance Concurrent Chemoradiotherapy Delivery: A Randomized Trial
- ClinicalTrials.gov ID
- NCT03115398
- Acronym / sponsor ID
- 2017-7472
- Keywords
- Fitness Tracker, Activity Monitoring, Chemotherapy, Radiation Therapy, Chemoradiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- 16 Feb 2017 (actual)
- Primary completion
- 3 Mar 2020 (actual)
- Study completion
- 3 Mar 2021 (actual)
- First posted
- 14 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Pedometer-based Walking ProgramSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pedometer-based Walking ProgramPatients 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. | Behavioural | Pedometer-based Walking Program |
Primary outcome
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.
8 secondary outcomes
Daily Step Counts
Time frame: During chemoradiotherapy and over the following 4 weeks (an average of 10 weeks)
Treatment-related Toxicities
Time frame: During chemoradiotherapy and over the following 4 weeks (an average of 10 weeks)
Patient-reported Quality of Life Scores
Time frame: During chemoradiotherapy and over the following 4 weeks (an average of 10 weeks)
Number of Emergency Room Visits
Time frame: During chemoradiotherapy and over the following 4 weeks (an average of 10 weeks)
Number of Hospitalizations
Time frame: During chemoradiotherapy and over the following 4 weeks (an average of 10 weeks)
Modified Glasgow Prognostic Scores
Time frame: During chemoradiotherapy and over the following 4 weeks (an average of 10 weeks)
Disease Progression or Recurrence
Time frame: Through study completion, an average of 1 year
Survival Status
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nitin Ohri, MD principal investigator
Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pedometer-based Walking Program in people with Brain Cancer and Head and Neck Cancer, run by Montefiore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Missed Scheduled Radiotherapy Treatments (time frame: During chemoradiotherapy (an average of 6 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.