Fitbit Assessed PS in Colorectal Cancer

Completed

• Conditions: Colorectal Cancer (Diagnosis)

• Registration Number: NCT07084181
• Lead Sponsor: Fox Chase Cancer Center

Brief Summary

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)

Detailed Description

Same as above

Study Timeline

• Study Start: 2017-02-15
• Primary Completion: 2019-07-22
• Study Completion: 2019-07-22
• Study First Submitted: 2025-07-16
• Study First Submitted QC: 2025-07-16
• Study First Posted: 2025-07-24
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-07
• Last Update Posted: 2025-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of usage	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	enrollment to 7 days	tracker assessed step count

Trial Locations

Locations (1)

Fox Chase Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States