Pancreatic CancerNCT03623464
RCT of Mobile Apps & FitBit v. Usual Care
A study of Pancreatic Cancer and Gastric Cancer, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
This is a randomized clinical trial to evaluate the use of mobile devices in preventing readmission in patients undergoing major GI cancer operations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Gastric Cancer, Hepatic Cancer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2017to Mar 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medicine- New York Presbyterian
New York, New York, 10021
About this study
Official title: Randomized Clinical Trial of FitBit and Mobile Apps Versus Usual Care to Improve Post-Operative Outcomes After GI Cancer Surgery
This is a randomized clinical trial to evaluate the use of mobile devices in preventing readmission in patients undergoing major GI cancer operations.
Read the 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.
- Conditions
- Pancreatic Cancer, Gastric Cancer, Hepatic Cancer, Colon Cancer, Rectal Cancer, Small Bowel Cancer
- Being tested
- Mobile health application and Fitbit + standard of care, Standard of care
- Medical subject headings
- Pancreatic Neoplasms, Stomach Neoplasms, Liver Neoplasms, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile health application and Fitbit + standard of careOther
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 careOther
Post-operative standard of care information
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Mobile health application and Fitbit + standard of care |
| Standard of care | Other | Participants will receive standard of care Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Readmission rate
Investigators will track readmission rates after surgery for those on the trial
Measured: 30 days
Secondary outcomes (4)
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.
Measured: 30 days
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.
Measured: 30 days
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.
Measured: 30 days
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start31 May 2017
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Why it stopped: Study is paused for interim analysis.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Damon Runyon Cancer Research Foundation
- Responsible party
- Sponsor
- Investigators
- Heather Yeo, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03623464
- Sponsor's protocol ID
- 1608017482
- Status last verified
- Sep 2026
- First submitted
- 24 Apr 2017
- Last updated
- 28 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of FitBit and Mobile Apps Versus Usual Care to Improve Post-Operative Outcomes After GI Cancer Surgery
- ClinicalTrials.gov ID
- NCT03623464
- Acronym / sponsor ID
- 1608017482
- Conditions
- Pancreatic Cancer, Gastric Cancer, Hepatic Cancer, Colon Cancer, Rectal Cancer, Small Bowel Cancer
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Study is paused for interim analysis.
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Damon Runyon Cancer Research Foundation
- Study start
- 31 May 2017 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 9 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile app and Fitbit + Standard of care | Active comparator | Other: Mobile health application and Fitbit + standard of careMobile 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. |
| Standard of care | Other | Other: Standard of careParticipants will receive standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile health application and Fitbit + standard of careMobility 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. | Other | Mobile app and Fitbit + Standard of care |
| Standard of carePost-operative standard of care information | Other | Standard of care |
Primary outcome
Readmission rate
Time frame: 30 days
Investigators will track readmission rates after surgery for those on the trial
4 secondary outcomes
Healthcare utilization rates
Time frame: 30 days
Patient Satisfaction with Device
Time frame: 30 days
Quality of life: Return to Baseline Function-Walking
Time frame: 30 days
Quality of life: Return to Baseline Function-Activities of Daily Living (ADLs)
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather Yeo, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Pancreatic Cancer and Gastric Cancer, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Readmission rate (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.