Fitbit Assessed PS in Colorectal Cancer

NCT07084181 | Completed

• 1 other identifier: 16-8023
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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)

Conditions

Colorectal Cancer (Diagnosis)

Keywords

Colorectal Cancer; Patient Reported Outcomes; Fitness Tracker

Outcome Measures

Primary Outcomes (2)

• Rate of usage

  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.

  4 days

• Steps

  tracker assessed step count

  enrollment to 7 days

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: No concern
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with colorectal cancer undergoing chemotherapy

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fox Chase Cancer Center: lead

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Related Publications (1)

• Ward WH, Meeker CR, Handorf E, Hill MV, Einarson M, Alpaugh RK, Holden TL, Astsaturov I, Denlinger CS, Hall MJ, Reddy SS, Sigurdson ER, Dotan E, Zibelman M, Meyer JE, Farma JM, Vijayvergia N. Feasibility of Fitness Tracker Usage to Assess Activity Level and Toxicities in Patients With Colorectal Cancer. JCO Clin Cancer Inform. 2021 Jan;5:125-133. doi: 10.1200/CCI.20.00117.

  PMID: 33492994 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood and serum frozen and stored

MeSH Terms

Conditions

Colorectal Neoplasms; Disease

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: July 24, 2025
• Study Start: February 15, 2017
• Primary Completion: July 22, 2019
• Study Completion: July 22, 2019
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

US (1)