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

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

Study Overview

• Status: Recruiting
• Conditions: Gastric Cancer; Pancreatic Cancer; Small Bowel Cancer; Rectal Cancer; Colon Cancer; Hepatic Cancer
• Intervention / Treatment: Other: Mobile health application and Fitbit + standard of care; Other: Standard of care

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.

• Study Type: Interventional
• Enrollment (Estimated): 316
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rohit Rasane; Phone Number: 646-962-2789; Email: rkr4044@med.cornell.edu
• Study Contact Backup: Name: Ananya Sen; Email: ase4003@med.cornell.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Recruiting
      • Weill Cornell Medicine- New York Presbyterian
      • Contact: Rohit Rasane; Phone Number: 646-962-2270

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subject is 18 years or older
2. Subject speaks English
3. Subject owns a smart phone
4. Subject is scheduled to undergo surgery for a GI cancer (pancreatic, hepatic, gastric, small bowel, colon, or rectal cancers)

Exclusion Criteria:

1. Physician deems the subject is unable to complete the study due to documented dementia
2. Subject is undergoing emergent surgery
3. Subject has sepsis from another source
4. Physician deems the subject is unable to complete the study due to documented alcohol and/or drug abuse

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Mobile app and Fitbit + Standard of care; Mobile health application and Fitbit + standard of care: Participants will utilize mobile app and Fitbit and standard of care. Mobility data will be generated using a mobile health tracker designed for smartphone devices.	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; Participants will receive standard of care	Other: Standard of care; Post-operative standard of care information

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Readmission rate	Investigators will track readmission rates after surgery for those on the trial	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healthcare utilization rates	Investigators will track patients' healthcare resource utilization and the cost of this utilization by assessing how often the patients contact their providers via phone or the app, access the emergency room, and through readmission data.	30 days
Patient Satisfaction with Device	Investigators will assess patients' satisfaction with their care experience and device. This will be done with an internal questionnaire asking if patients were satisfied and if they found it easy to use.	30 days
Quality of life: Return to Baseline Function-Walking	Investigators will monitor patients' return to baseline health after surgery by tracking progress via step counts, as monitored by a FitBit tracker.	30 days
Quality of life: Return to Baseline Function-Activities of Daily Living (ADLs)	Investigators will monitor patients' return to baseline health after surgery by tracking progress using a questionnaire, modified from the Katz Activities of Daily Living scale. For this scale, a score of 6 is high, indicating that the patient is independent and a score of 0 is low, indicating that the patient very dependent in performing their ADLs.	30 days

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: Damon Runyon Cancer Research Foundation
• Investigators: Principal Investigator: Heather Yeo, MD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2017
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: April 24, 2017
• First Submitted That Met QC Criteria: August 6, 2018
• First Posted (Actual): August 9, 2018

Study Record Updates

• Last Update Posted (Actual): November 15, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms
• Other Study ID Numbers: 1608017482

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No