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Ambulatory Cancer Care Electronic Symptom Self-Reporting for Surgical Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03178045
Recruitment Status : Active, not recruiting
First Posted : June 6, 2017
Last Update Posted : April 30, 2020
Sponsor:
Collaborators:
Brigham and Women's Hospital
University of Rochester
Weill Medical College of Cornell University
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:
The aim of this study is to understand and improve the experience of patients after surgery by comparing two methods of following symptoms while the patient recovers at home.

Condition or disease Intervention/treatment
Patient Reported Outcomes Other: Team Monitoring Other: Enhanced Feedback

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Study Type : Observational
Estimated Enrollment : 2636 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ambulatory Cancer Care Electronic Symptom Self-Reporting for Surgical Patients
Actual Study Start Date : May 31, 2017
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Group/Cohort Intervention/treatment
Team Monitoring
Team Monitoring is the current standard of care for patients at Josie Robertson Surgery Center (JRSC).
Other: Team Monitoring
In this cohort, the electronic system will provide advanced informatics support for push notifications to the care team based on the severity of the symptoms reported. This platform promotes early detection and intervention. The care team is alerted when patients experience symptoms out of the expected range or if symptoms are worsening. Nurses receive secure message notifications and will contact the patient by phone depending on symptom severity. If a patient responds with a moderate-severe answer, the office team gets an alert and calls the patient during business hours.

Enhanced Feedback
The electronic system will provide tailored normative data visualizations that offer context and education to patients regarding expected symptom severity.
Other: Enhanced Feedback
In this cohort, the electronic system will provide tailored normative data visualizations that offer context and education to patients regarding expected symptom severity. The information provided to patients in the Enhanced Feedback group will be procedure specific and based on continuously updated PRO-CTCAE data from previous patients. Patients are thus able to see their own recovery trajectory relative to that of patients who have undergone the same procedure. Care is patient activated in that patients will use the information about expected symptoms to decide whether they should call the care team (e.g., if they are experiencing symptoms that are more severe or more prolonged than expected). If a patient reports severe symptoms, they are instructed to immediately contact their physician's office or seek medical attention.




Primary Outcome Measures :
  1. number of emergency department visits up to 30 days [ Time Frame: 30 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
All patients who are scheduled for surgery at Josie Robertson Surgery Center (JRSC).
Criteria

Inclusion Criteria:

  • All patients >18 years of age who are scheduled for ambulatory cancer surgery at JRSC and their caregivers will be eligible for study participation.

Exclusion Criteria:

  • Inability to speak English
  • Inability to access a computer, tablet, or mobile phone
  • For patients: not interested in/unable to sign up for the MyMSK Patient Portal
  • For caregivers: Unable to provide an email address
  • Cognitive impairment that prohibits informed consent or understanding of the study protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03178045


Locations
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United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Brigham and Women's Hospital
University of Rochester
Weill Medical College of Cornell University
Investigators
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Principal Investigator: Brett Simon, MD Memorial Sloan Kettering Cancer Center
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03178045    
Other Study ID Numbers: 17-293
First Posted: June 6, 2017    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No