Fitbit Assessed PS in Colorectal Cancer

Primary Objective

To assess the feasibility of activity tracking using Fitbit device in terms of compliance (defined as at least 75% of patients complying with instructions to wear the device, for at least 12 hours a day on at least 3 of the 4 assigned days) in patients undergoing therapy for localized and advanced colorectal cancer.

Secondary Objectives

* To determine if physician-assessed performance status correlates with FitbitTM assessed physical activity (using active-minutes data). * To correlate baseline physical activity level as assessed by FitbitTM with incidence of grade III or higher toxicities experienced during treatment * To assess correlation between patient reported treatment related toxicities (PRO-CTCAE) and objective physical activity as measured by FitbitTM in patients treated for localized or metastatic cancers treated with chemotherapy * To correlate baseline and interval change in physical activity levels as assessed by FitbitTM with post-surgical outcomes including inpatient length of stay, perioperative complications, post-operative 30-day mortality, and time to adjuvant treatment initiation (in days)

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Key information

Conditions

Colorectal Cancer (Diagnosis) Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Disease Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age 18 years or older
Have histologically confirmed colorectal adenocarcinoma (Stage II-IV)
Have an estimated life expectancy of greater than 3 months
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Should meet the following treatment arms:

Planned to undergo curative resection with or without neoadjuvant/adjuvant therapy for colorectal cancer (surgical arm);
Planned to undergo/undergoing systemic chemotherapy for localized/metastatic colorectal cancer - medical arm (patient enrolled on one arm may not enroll onto the other arm)
Able to participate in some degree of physical activity (i.e. walking)
Are undergoing treatment for their cancer at FCCC
Ability to understand and willingness to sign a written informed consent and HIPAA consent

Exclusion criteria

Inability to communicate in English.
Already using a personal activity tracker
Enrolled in another study in which physical activity is part or all of the therapeutic intervention or is being evaluated
Pre-existing toxicity >grade II
PS >3 for any reason

Treatment and study plan

Primary outcomes

Rate of usage

Time frame: 4 days

To assess the feasibility of activity tracking using Fitbit device in terms of compliance (defined as at least 75% of patients complying with instructions to wear the device, for at least 12 hours a day on at least 3 of the 4 assigned days) in patients undergoing therapy for localized and advanced colorectal cancer.
Steps

Time frame: enrollment to 7 days

tracker assessed step count

Sponsors and collaborators

Lead sponsor

Fox Chase Cancer Center

Other

Registry information

Official study title

Get Your Rear In Gear Study: Feasibility of Using Fitness Tracker to Assess Activity Level and Toxicities in Patients With Localized/Advanced Colorectal Cancer: A Fox Chase Cancer Center Pilot Study

Important dates

Study start: 2017
Primary completion: 2019
Study completion: 2019
First posted: Jul 24, 2025
Registry last updated: Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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