Ambulatory Cancer Care Electronic Symptom Self-Reporting for Surgical Patients

NCT ID: NCT03178045

Last Updated: 2023-06-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2793 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-31

Study Completion Date

2023-05-25

Brief Summary

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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.

Detailed Description

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Conditions

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Patient Reported Outcomes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Team Monitoring

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

Team Monitoring

Intervention Type 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.

Enhanced Feedback

The electronic system will provide tailored normative data visualizations that offer context and education to patients regarding expected symptom severity.

Enhanced Feedback

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Brigham and Women's Hospital

OTHER

Sponsor Role collaborator

University of Rochester

OTHER

Sponsor Role collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Allen, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 31530612 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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http://www.mskcc.org/mskcc/html/44.cfm

Memorial Sloan Kettering Cancer Center

Other Identifiers

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17-293

Identifier Type: -

Identifier Source: org_study_id

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