Real-time Activity Monitoring to Prevent Admissions During RadioTherapy

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.

• Enhanced Supportive Care - Status Checks (Other), also known as Daily Status Checks: Would occur everyday during treatment when a patient is deemed high-risk.
• Enhanced Supportive Care - Referrals (Other), also known as Referrals: On an as-need basis, high risk patients can be referred to our nutritionist or palliative care doctor.

Primary outcomes

• Number of patients hospitalized during treatment or within 4 weeks after completing radiotherapy. [During chemoradiotherapy or within 4 weeks after completion of radiotherapy.]: The primary endpoint of this study is hospitalization during chemoradiotherapy or within 4 weeks after completion of radiotherapy.

Secondary outcomes

• Activation of the enhanced supportive care protocol [During chemoradiotherapy or within 4 weeks after completion of radiotherapy.]: Activation of the enhanced supportive care protocol (multidisciplinary evaluation and daily nursing/physician visits) based on recent step count data.
• Frequency of clinician visits and supportive care measures implemented. [During chemoradiotherapy or within 4 weeks after completion of radiotherapy]: Clinician visits and supportive care measures that result from activation of the enhanced supportive care protocol
• Patient-reported quality of life scores [During chemoradiotherapy or within 4 weeks after completion of radiotherapy.]: Patient-reported quality of life scores, measured using the EORTC QLC-C30 questionnaire.
• Treatment-related toxicities [During chemoradiotherapy or within 4 weeks after completion of radiotherapy.]: Treatment-related toxicities, scored using CTCAE version 4.03.
• Disease status [During chemoradiotherapy and up to two years after completion of radiotherapy.]: Disease progression or recurrence
• Survival status [During chemoradiotherapy and and up to two years after completion of radiotherapy.]
• Modified Glasgow Prognostic Score [From time of registration to up to 4 weeks after completion of radiotherapy.]: Modified Glasgow Prognostic Score will be measured as a function of the C-Reactive Protein and Albumin levels that are collected throughout the study.

Sex: All, ages: 18 Years to any

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.