RCT of Mobile Apps & FitBit v. Usual Care

NCT03623464 | Active Not Recruiting

• 1 other identifier: 1608017482
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Readmission rate

  Investigators will track readmission rates after surgery for those on the trial

  30 days

Secondary Outcomes (4)

• Healthcare utilization rates

  30 days

• Patient Satisfaction with Device

  30 days

• Quality of life: Return to Baseline Function-Walking

  30 days

• Quality of life: Return to Baseline Function-Activities of Daily Living (ADLs)

  30 days

Study Arms (2)

Mobile app and Fitbit + Standard of care

ACTIVE COMPARATOR

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

Standard of care

OTHER

Participants will receive standard of care

Other: Standard of care

Interventions

Mobile health application and Fitbit + standard of care OTHER

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.

Mobile app and Fitbit + Standard of care

Standard of care OTHER

Post-operative standard of care information

Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Damon Runyon Cancer Research Foundation: collaborator

Study Sites (1)

Weill Cornell Medicine- New York Presbyterian

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Stomach Neoplasms; Liver Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Liver Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Heather Yeo, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2017
• First Posted: August 9, 2018
• Study Start: May 31, 2017
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)