Fitbit Assessed PS in Colorectal Cancer

NCT ID: NCT07084181

Last Updated: 2025-08-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-02-15
• Study Completion Date: 2019-07-22

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)

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fox Chase Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 33492994 (View on PubMed)

Other Identifiers

16-8023

Identifier Type: OTHER

Identifier Source: secondary_id

16-8023

Identifier Type: -

Identifier Source: org_study_id