RCT of Mobile Apps & FitBit v. Usual Care

NCT ID: NCT03623464

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-31

Study Completion Date

2026-06-30

Brief Summary

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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

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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

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Mobile health application and Fitbit + standard of care

Intervention Type 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

Participants will receive standard of care

Group Type OTHER

Standard of care

Intervention Type OTHER

Post-operative standard of care information

Interventions

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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.

Intervention Type OTHER

Standard of care

Post-operative standard of care information

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Damon Runyon Cancer Research Foundation

OTHER

Sponsor Role collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Heather Yeo, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

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Weill Cornell Medicine- New York Presbyterian

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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1608017482

Identifier Type: -

Identifier Source: org_study_id