Ambulatory Cancer Care Electronic Symptom Self-Reporting for Surgical Patients

NCT03178045 | Completed Results

• 1 other identifier: 17-293
• Study Type: observational
• Target: 2,793
• Locations: 1 country
• Sites: 1

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.

Conditions

Patient Reported Outcomes

Outcome Measures

Primary Outcomes (1)

• Rates of UCC Visits and Readmissions Between the Team Monitoring and Enhanced Feedback Cohorts up to 30 Days Post-operatively

  To compare the effectiveness of Team Monitoring and Enhanced Feedback with regard to urgent care, emergency department visits, and readmissions up to 30 days post-operatively.

  30 days

Secondary Outcomes (9)

• Difference in Total Number of Nursing Follow-up Calls Between Team Monitoring and Enhanced Feedback Cohorts up to 30 Days Post-Operatively

  30 days post-operatively

• Differences in Total Number of Unplanned Clinic Visits Between Team Monitoring and Enhanced Feedback Cohorts Up to 30 Days Post-Operatively

  30 days post-operatively

• Differences in Total Number of Pain Management Referrals Between Team Monitoring and Enhanced Feedback Cohorts Up to 30 Days Post-Operatively

  30 days post-operatively

• Differences in Adverse Events Between Team Monitoring and Enhanced Feedback Cohorts Up to 30 Days Post-Operatively

  30 days post-operatively

• Interaction in Participants Anxiety Measured by 3 Items on the Patient Reported Outcome Common Terminology Criteria for Adverse Events Survey (PRO-CTCAE)

  10 days post-operatively

Study Arms (2)

Team Monitoring

Team Monitoring is the current standard of care for patients at Josie Robertson Surgery Center (JRSC).

Other: Team Monitoring

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

Interventions

Team Monitoring OTHER

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.

Team Monitoring

Enhanced Feedback OTHER

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.

Enhanced Feedback

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients who are scheduled for surgery at Josie Robertson Surgery Center (JRSC).

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Brigham and Women's Hospital: collaborator
• University of Rochester: collaborator
• Weill Medical College of Cornell University: collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Publications (1)

• Stabile C, Temple LK, Ancker JS, Basch E, Carter J, Miranda M, Stein D, Stetson PD, Vickers A, Simon BA, Pusic AL. Ambulatory cancer care electronic symptom self-reporting (ACCESS) for surgical patients: a randomised controlled trial protocol. BMJ Open. 2019 Sep 17;9(9):e030863. doi: 10.1136/bmjopen-2019-030863.

  PMID: 31530612 DERIVED

Related Links

• Memorial Sloan Kettering Cancer Center

Results Point of Contact

• Title: Robert Allen Jr., MD
• Organization: Memorial Sloan Kettering Cancer Center

allenr1@mskcc.org

646-608-8041

Study Officials

• Robert Allen, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2017
• First Posted: June 6, 2017
• Study Start: May 31, 2017
• Primary Completion: October 30, 2019
• Study Completion: May 25, 2023
• Last Updated: June 23, 2023
• Results First Posted: November 17, 2020

Record last verified: 2023-05

Locations

US (1)