Ambulatory Cancer Care Electronic Symptom Self-Reporting for Surgical Patients

Patient Reported Outcomes Clinical Trial

Official title:

Ambulatory Cancer Care Electronic Symptom Self-Reporting for Surgical Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03178045
• Other study ID #: 17-293
• Status: Completed
• Start date: May 31, 2017
• Est. completion date: May 25, 2023

Study information

• Verified date: May 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2793
• Est. completion date: May 25, 2023
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Patient Reported Outcomes

Intervention

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
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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (4)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Brigham and Women's Hospital, University of Rochester, Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Difference in Total Number of Nursing Follow-up Calls Between Team Monitoring and Enhanced Feedback Cohorts up to 30 Days Post-Operatively	To evaluate the difference in nursing phone calls between each study arm up to 30 days post-operatively.	30 days post-operatively
Secondary	Differences in Total Number of Unplanned Clinic Visits Between Team Monitoring and Enhanced Feedback Cohorts Up to 30 Days Post-Operatively	To evaluate the difference in unplanned clinic visits and phone referrals to clinic between each study arm up to 30 days post-operatively.	30 days post-operatively
Secondary	Differences in Total Number of Pain Management Referrals Between Team Monitoring and Enhanced Feedback Cohorts Up to 30 Days Post-Operatively	To evaluate the difference in pain management referrals between each study arm up to 30 days post-operatively.	30 days post-operatively
Secondary	Differences in Adverse Events Between Team Monitoring and Enhanced Feedback Cohorts Up to 30 Days Post-Operatively	To evaluate the difference in adverse events between each study arm up to 30 days post-operatively.	30 days post-operatively
Secondary	Interaction in Participants Anxiety Measured by 3 Items on the Patient Reported Outcome Common Terminology Criteria for Adverse Events Survey (PRO-CTCAE)	This analysis utilized 3 anxiety items from the PRO-CTCAE survey. The responses were defined on a scale of 0-4 with higher scores representing stronger agreement with the item (higher anxiety). The 3 items were summed to generate an overall score ranging from 0-12. 139 patients responded to only some of the 3 items and were counted as a missing value for the overall sum score. As the surveys were repeated daily, longitudinal mixed effects regression was used to test the association between the anxiety sum score and randomization arm after adjusting for time, randomization strata, and an interaction between randomization arm and time with a random intercept for patient.	10 days post-operatively
Secondary	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	To evaluate the difference in patient engagement between each study arm at 14 days post-operatively adjusting for strata and preoperative PAM overall score. The survey consists of 10 items with five response options: strongly disagree, disagree, undecided, agree and strongly agree defined on a scale of 1-5 with higher scores representing stronger agreement with the item. The items in the PAM survey were combined to generate an overall mean score at each timepoint - a theoretical score of 0-100. A higher score indicates stronger patient engagement. If a patient is missing a response to an item(s), the overall score is considered missing for that patient/timepoint. Participants who answered the survey were included in this analysis. 560 patients were analyzed in the Team Monitoring Arm and 541 were analyzed in the Enhanced Feedback Arm.	14 days post-operatively
Secondary	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	To evaluate the difference in patient engagement between each study arm 60 days post-operatively adjusting for strata and preoperative PAM overall score. The survey consists of 10 items with five response options: strongly disagree, disagree, undecided, agree and strongly agree defined on a scale of 1-5 with higher scores representing stronger agreement with the item. The items in the PAM survey were combined to generate an overall mean score at each timepoint - a theoretical score of 0-100. A higher score indicates stronger patient engagement. If a patient is missing a response to an item(s), the overall score is considered missing for that patient/timepoint. 465 participants form the Team Monitoring Arm and 460 participants from the Enhanced Feedback arm were analyzed who answered the Patient Activation Measure at POD 60.	60 days post-operatively
Secondary	Differences in Caregiver Burden Between Team Monitoring and Enhanced Feedback Cohorts Utilizing the Caregiver Reaction Assessment (CRA).	To evaluate the difference in caregiver burden between each study arm at two timepoints: 14 days post-operatively. Scoring information for the CRA: The Caregiver Reaction Assessment involved 24 items given at 14 days and repeated at 60 days with the following potential responses: strongly disagree, disagree, undecided, agree, and strongly agree which we defined on a scale of 1-5 with higher scores representing stronger agreement with the item. These items are combined into 5 subscales: health problems, financial problems, lack of family support, disrupted schedule, and self-esteem. For each subscale, a total score was computed as the average of the subsequent item scores, with a range between 1 and 5. A higher score represented a stronger agreement with the attribute.	14 days post-operatively
Secondary	Differences in Caregiver Burden Between Team Monitoring and Enhanced Feedback Cohorts Utilizing the Caregiver Reaction Assessment (CRA).	To evaluate the difference in caregiver burden between each study arm at two timepoints: 60 days post-operatively. Scoring information for the CRA: The Caregiver Reaction Assessment involved 24 items given at 14 days and repeated at 60 days with the following potential responses: strongly disagree, disagree, undecided, agree, and strongly agree which we defined on a scale of 1-5 with higher scores representing stronger agreement with the item. These items are combined into 5 subscales: health problems, financial problems, lack of family support, disrupted schedule, and self-esteem. For each subscale, a total score was computed as the average of the subsequent item scores, with a range between 1 and 5. A higher score represented a stronger agreement with the attribute.	60 days post-operatively

External Links

•   Memorial Sloan Kettering Cancer Center