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OpenTrials
Active, Not Recruiting

NCT Number: NCT03623464

RCT of Mobile Apps & FitBit v. Usual Care

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Pancreatic Cancer Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Hepatic Cancer Intestinal Diseases Intestinal Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms Rectal Cancer Rectal Diseases Rectal Neoplasms Small Bowel Cancer Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Weill Cornell Medicine- New York Presbyterian

New York, 10021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

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.

Standard of care

Other

Post-operative standard of care information

Primary outcomes

  1. Readmission rate

    Time frame: 30 days

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

Secondary outcomes

  1. Healthcare utilization rates

    Time frame: 30 days

    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.

  2. Patient Satisfaction with Device

    Time frame: 30 days

    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.

  3. Quality of life: Return to Baseline Function-Walking

    Time frame: 30 days

    Investigators will monitor patients' return to baseline health after surgery by tracking progress via step counts, as monitored by a FitBit tracker.

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

    Time frame: 30 days

    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.

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • Damon Runyon Cancer Research Foundation

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2026
Study completion
2026
First posted
Aug 9, 2018
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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