Clinical trial NCT03178045: Ambulatory Cancer Care Electronic Symptom Self-Reporting for Surgical Patients
Official title: Ambulatory Cancer Care Electronic Symptom Self-Reporting for Surgical Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patient Reported Outcomes
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
name: University of Rochester
name: Weill Medical College of Cornell University
First posted: 2017-06-06
Enrollment: 2793
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients who are scheduled for surgery at Josie Robertson Surgery Center (JRSC).

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.


Eligibility 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

Primary outcomes:
measure: Rates of UCC Visits and Readmissions Between the Team Monitoring and Enhanced Feedback Cohorts up to 30 Days Post-operatively
timeFrame: 30 days
Secondary outcomes:
measure: Difference in Total Number of Nursing Follow-up Calls Between Team Monitoring and Enhanced Feedback Cohorts up to 30 Days Post-Operatively
timeFrame: 30 days post-operatively
measure: Differences in Total Number of Unplanned Clinic Visits Between Team Monitoring and Enhanced Feedback Cohorts Up to 30 Days Post-Operatively
timeFrame: 30 days post-operatively
measure: Differences in Total Number of Pain Management Referrals Between Team Monitoring and Enhanced Feedback Cohorts Up to 30 Days Post-Operatively
timeFrame: 30 days post-operatively
measure: Differences in Adverse Events Between Team Monitoring and Enhanced Feedback Cohorts Up to 30 Days Post-Operatively
timeFrame: 30 days post-operatively
measure: Interaction in Participants Anxiety Measured by 3 Items on the Patient Reported Outcome Common Terminology Criteria for Adverse Events Survey (PRO-CTCAE)
timeFrame: 10 days post-operatively
measure: Differences in Patient Engagement Between Cohorts at 14 Days Post-Operatively Utilizing the Patient Activation Measure (PAM) and Adjusting for Strata and Pre-Operative PAM Score
timeFrame: 14 days post-operatively
measure: Differences in Patient Engagement Between Team Monitoring and Enhanced Feedback Cohorts at 60 Days Post-Operatively Utilizing the Patient Activation Measure (PAM) and Adjusting for Strata and Pre-Operative PAM Score
timeFrame: 60 days post-operatively
measure: Differences in Caregiver Burden Between Team Monitoring and Enhanced Feedback Cohorts Utilizing the Caregiver Reaction Assessment (CRA).
timeFrame: 14 days post-operatively
measure: Differences in Caregiver Burden Between Team Monitoring and Enhanced Feedback Cohorts Utilizing the Caregiver Reaction Assessment (CRA).
timeFrame: 60 days post-operatively
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Robert Allen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.