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This study will aim to demonstrate that implementation of a rapid, multidisciplinary supportive care program for patients receiving chemoradiotherapy who are deemed to be at high risk for hospitalization based on real-time pedometer data will reduce the rate of hospitalization during chemoradiotherapy or within four weeks of radiotherapy completion.
Primary Objective
Secondary Objectives
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Activity Monitoring | Experimental |
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced Supportive Care - Status Checks | Other | Would occur everyday during treatment when a patient is deemed high-risk. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients hospitalized during treatment or within 4 weeks after completing radiotherapy. | The primary endpoint of this study is hospitalization during chemoradiotherapy or within 4 weeks after completion of radiotherapy. | During chemoradiotherapy or within 4 weeks after completion of radiotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Activation of the enhanced supportive care protocol | Activation of the enhanced supportive care protocol (multidisciplinary evaluation and daily nursing/physician visits) based on recent step count data. | During chemoradiotherapy or within 4 weeks after completion of radiotherapy. |
| Frequency of clinician visits and supportive care measures implemented. |
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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 head and neck region, lung, esophagus, or stomach
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:
All patients must sign study specific informed consent prior to study entry.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D008175 | Lung Neoplasms |
| D004938 | Esophageal Neoplasms |
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
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| ID | Term |
|---|---|
| D012017 | Referral and Consultation |
| ID | Term |
|---|---|
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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| Enhanced Supportive Care - Referrals | Other | On an as-need basis, high risk patients can be referred to our nutritionist or palliative care doctor. |
|
|
Clinician visits and supportive care measures that result from activation of the enhanced supportive care protocol |
| During chemoradiotherapy or within 4 weeks after completion of radiotherapy |
| Patient-reported quality of life scores | Patient-reported quality of life scores, measured using the EORTC QLC-C30 questionnaire. | During chemoradiotherapy or within 4 weeks after completion of radiotherapy. |
| Treatment-related toxicities | Treatment-related toxicities, scored using CTCAE version 4.03. | During chemoradiotherapy or within 4 weeks after completion of radiotherapy. |
| Disease status | Disease progression or recurrence | During chemoradiotherapy and up to two years after completion of radiotherapy. |
| Survival status | During chemoradiotherapy and and up to two years after completion of radiotherapy. |
| Modified Glasgow Prognostic Score | Modified Glasgow Prognostic Score will be measured as a function of the C-Reactive Protein and Albumin levels that are collected throughout the study. | From time of registration to up to 4 weeks after completion of radiotherapy. |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |