RCT of Mobile Apps & FitBit v. Usual Care

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03623464
• Other study ID #: 1608017482
• Status: Recruiting
• Phase: N/A
• Start date: May 31, 2017
• Est. completion date: February 2025

Study information

• Verified date: November 2023
• Source: Weill Medical College of Cornell University
• Contact: Rohit Rasane
• Phone: 646-962-2789
• Email: rkr4044[@]med.cornell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 316
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• Standard of care
Post-operative standard of care information

Locations

Country	Name	City	State
United States	Weill Cornell Medicine- New York Presbyterian	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Damon Runyon Cancer Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Readmission rate	Investigators will track readmission rates after surgery for those on the trial	30 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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