Purpose

By utilizing fitness trackers, this study aims to demonstrate that a simple walking program improves patients' ability to tolerate curative concurrent chemoradiotherapy without treatment interruption.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Criteria


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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
No Intervention
Activity Monitoring with Routine Care
Subjects randomized to the control arm will wear activity trackers but will have no specific instructions to increase their activity levels.
Experimental
Pedometer-based Walking Program
Subjects randomized to the experimental arm will be instructed to meet the customized daily step count goals that are displayed on their fitness trackers. Patients 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.
  • Behavioral: Pedometer-based Walking Program
    Patients will be instructed to meet the daily step count goal displayed on their fitness tracker. If goal is not being met, study team will intervene and reinforce the importance of meeting this goal. Intervention will include a conversation with the patient, led by a study coordinator, to identify any challenges present in meeting the prescribed goal. Solutions to such challenges may be offered by the coordinator or necessary provider, such as a dietitian, when applicable.

More Details

Status
Active, not recruiting
Sponsor
Albert Einstein College of Medicine

Study Contact

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.