A Simple Walking Program to Enhance Concurrent Chemoradiotherapy Delivery

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.

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 brain, head and neck region, lung,
gastrointestinal tract, or uterine cervix

- 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.