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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Daily Step Counts | Step counts will be recorded and measured daily from patients' fitness trackers. | During chemoradiotherapy and over the following 4 weeks (an average of 10 weeks) |
| Treatment-related Toxicities |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nitin Ohri, MD | Albert Einstein College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D008175 | Lung Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Toxicities will be evaluated each week and scored using CTCAE version 4.03.
| 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. | 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. | 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. | 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. | 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 | 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. | Through study completion, an average of 1 year |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |