NCT03623464

RCT of Mobile Apps & FitBit v. Usual Care

Randomized Clinical Trial of FitBit and Mobile Apps Versus Usual Care to Improve Post-Operative Outcomes After GI Cancer Surgery

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized clinical trial to evaluate the use of mobile devices in preventing readmission in patients undergoing major GI cancer operations.

Detailed description

Patients will be randomized to 1) standard of care or 2) to use our mobile app with standard care. The mobile app will collect information on patients' daily physical activity patterns and health status data for clinicians using smartphone mobile technology applications. The investigators believe that by tracking information on patients, the investigators may be able to intervene sooner and prevent a delay in care.

Conditions

• Pancreatic Cancer
• Gastric Cancer
• Hepatic Cancer
• Colon Cancer
• Rectal Cancer
• Small Bowel Cancer

Interventions

Type	Name	Description
OTHER	Mobile health application and Fitbit + standard of care	Mobility data will be generated using a mobile health tracker designed for smartphone devices, which allows the phone to automatically and passively (no patient input needed) capture information on the patient's activity; i.e. if the person is walking, remaining stationary, or moving at a rapid speed (eg. in a car). The app will prompt patients once daily to answer a series of questions that will collect patient reported symptoms and health status data. Physicians will be alerted to abnormal values within 24-48 hours and patients will be triggered to call their physicians immediately if the values are outside of normal parameters.
OTHER	Standard of care	Post-operative standard of care information

Timeline

• Start date: 2017-05-31
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2018-08-09
• Last updated: 2025-12-17

Locations

1 site across 1 country: United States