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.

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.