Real-time Activity Monitoring to Prevent Admissions During RadioTherapy

Study Overview
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Brief Summary
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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.

Detailed Description
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Primary Objective 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. Secondary Objectives To demonstrate the feasibility of a program of rapid, multidisciplinary supportive care triggered by real-time pedometer data. To characterize the interventions enacted by our multidisciplinary supportive care team. To explore if interventions enacted by our multidisciplinary team for patients with low recent step counts lead to increased step counts in subsequent weeks compared to historical controls. To collect biospecimens for future correlative studies examining associations between blood/urine biomarkers and patient activity levels.

Official Title
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Real-time Activity Monitoring to Prevent Admissions During RadioTherapy

Conditions
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Cancer of the Head and Neck, Cancer of Lung, Cancer of Esophagus, Cancer of Stomach

Intervention / Treatment
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* Other: Enhanced Supportive Care - Status Checks
* Other: Enhanced Supportive Care - Referrals


Participation Criteria
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Eligibility Criteria
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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: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Activity Monitoring<br>Enhanced Supportive Care - Status Checks Would occur everyday during treatment when a patient is deemed high-risk based on activity level. Other Names: •Daily Status Checks Enhanced Supportive Care - Referrals On an as-need basis, high risk patients can be referred to our nutritionist or palliative care doctor. Other Names: •Referrals | Other: Enhanced Supportive Care - Status Checks<br>* Would occur everyday during treatment when a patient is deemed high-risk.<br>* Other names: Daily Status Checks;Other: Enhanced Supportive Care - Referrals<br>* On an as-need basis, high risk patients can be referred to our nutritionist or palliative care doctor.<br>* Other names: Referrals;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Activity Monitoring, Chemotherapy, Radiotherapy