Colon Cancer, Gastric Cancer, Hepatic Cancer, Pancreatic Cancer, Rectal Cancer, Small Bowel Cancer
Conditions
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.
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.
Interventions
OTHERMobile 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.
OTHERStandard of care
Post-operative standard of care information
Sponsors
Damon Runyon Cancer Research Foundation
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Readmission rate | 30 days | Investigators will track readmission rates after surgery for those on the trial |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Healthcare utilization rates | 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. |
| Patient Satisfaction with Device | 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. |
| Quality of life: Return to Baseline Function-Walking | 30 days | Investigators will monitor patients' return to baseline health after surgery by tracking progress via step counts, as monitored by a FitBit tracker. |
| Quality of life: Return to Baseline Function-Activities of Daily Living (ADLs) | 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. |
Countries
United States
Outcome results
None listed