Fitbit Assessed PS in Colorectal Cancer (NCT07084181) | Clinical Trial Compass
CompletedNot Applicable
Fitbit Assessed PS in Colorectal Cancer
United States80 participantsStarted 2017-02-15
Plain-language 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)
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.