Colorectal Cancer (Diagnosis)
Conditions
Keywords
Colorectal Cancer, Patient Reported Outcomes, Fitness Tracker
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)
Interventions
None listed
Sponsors
Fox Chase Cancer Center
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed