Colorectal Cancer (Diagnosis)NCT07084181
Fitbit Assessed PS in Colorectal Cancer
An observational study of Colorectal Cancer (Diagnosis), run by Fox Chase Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer (Diagnosis)
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2017to 22 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with colorectal cancer undergoing chemotherapy
Who may be able to join
- 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);
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
About this study
Official title: 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
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.
Read more
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
- Medical subject headings
- Colorectal Neoplasms, Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 days
Steps
tracker assessed step count
Measured: enrollment to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start15 Feb 2017
- Primary completion22 Jul 2019
- Study completion22 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal Cancer (Diagnosis)Studies of the same condition, open and under way.
- More trials run by Fox Chase Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07084181
- Sponsor's protocol ID
- 16-8023
- Other IDs
- 16-8023
- Status last verified
- Aug 2025
- First submitted
- 16 Jul 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: At reasonable request to PI
Publications
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.
PubMed 33492994
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07084181
- Acronym / sponsor ID
- 16-8023
- Conditions
- Colorectal Cancer (Diagnosis)
- Keywords
- Colorectal Cancer, Patient Reported Outcomes, Fitness Tracker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Study start
- 15 Feb 2017 (actual)
- Primary completion
- 22 Jul 2019 (actual)
- Study completion
- 22 Jul 2019 (actual)
- First posted
- 24 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with colorectal cancer undergoing chemotherapy
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of usage
Time frame: 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
Time frame: enrollment to 7 days
tracker assessed step count
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Results publication: PubMed 33492994Ward 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.
- Individual participant dataSharing planned: Yes. At reasonable request to PI
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer (Diagnosis), run by Fox Chase Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of usage (time frame: 4 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07084181, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.