Clinical trial · Observational
Fitbit Assessed PS in Colorectal Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer (Diagnosis) | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Rate of usage
- timeFrame
- 4 days
- description
- 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.
- measure
- Steps
- timeFrame
- enrollment to 7 days
- description
- tracker assessed step count
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTWard 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