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
Verified date | May 2024 |
Source | Weill Medical College of Cornell University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a randomized clinical trial to evaluate the use of mobile devices in preventing readmission in patients undergoing major GI cancer operations.
Status | Active, not recruiting |
Enrollment | 107 |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Weill Cornell Medicine- New York Presbyterian | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Weill Medical College of Cornell University | Damon Runyon Cancer Research Foundation |
United States,
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 |
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