Ambulatory Cancer Care Electronic Symptom Self-Reporting for Surgical Patients

Completed

• Conditions: Patient Reported Outcomes
• Interventions: Other: Team Monitoring; Other: Enhanced Feedback

• Registration Number: NCT03178045
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-31
• Study First Submitted: 2017-06-02
• Study First Submitted QC: 2017-06-05
• Study First Posted: 2017-06-06
• Primary Completion: 2019-10-30
• Results First Submitted: 2020-08-14
• Results First Submitted QC: 2020-10-26
• Results First Posted: 2020-11-17
• Status Verified: 2023-05
• Study Completion: 2023-05-25
• Last Update Submitted: 2023-05-25
• Last Update Posted: 2023-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2793

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Team Monitoring	Team Monitoring	Team Monitoring is the current standard of care for patients at Josie Robertson Surgery Center (JRSC).
Enhanced Feedback	Enhanced Feedback	The electronic system will provide tailored normative data visualizations that offer context and education to patients regarding expected symptom severity.

Primary Outcome Measures

Name	Time	Method
Rates of UCC Visits and Readmissions Between the Team Monitoring and Enhanced Feedback Cohorts up to 30 Days Post-operatively	30 days	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.

Secondary Outcome Measures

Name	Time	Method
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	To evaluate the difference in unplanned clinic visits and phone referrals to clinic between each study arm up to 30 days post-operatively.
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	14 days post-operatively	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.
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	60 days post-operatively	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.
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	To evaluate the difference in nursing phone calls between each study arm up to 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	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.
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	To evaluate the difference in pain management referrals between each study arm up to 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	To evaluate the difference in adverse events between each study arm up to 30 days post-operatively.
Differences in Caregiver Burden Between Team Monitoring and Enhanced Feedback Cohorts Utilizing the Caregiver Reaction Assessment (CRA).	60 days post-operatively	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.

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States