NCT03850912

Symptom Management Implementation of Patient Reported Outcomes in Oncology

SIMPRO Research Center: Integration and Implementation of PROs for Symptom Management in Oncology Practice

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42,808 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Deficits in the management of common symptoms cause substantial morbidity for cancer patients.Because the health care delivery system is structured to be reactive and not proactive, there are missed opportunities to optimize symptom control. Growth in Internet access and proliferation of smartphones has created an opportunity to re-engineer cancer care delivery. Electronic symptom tracking and feedback is a promising strategy to improve symptom control. Electronic patient reported outcome (ePRO) monitoring of cancer symptoms has been shown to decrease symptom burden, improve quality of life, reduce acute care and even extend survival. SIMPRO will use functioning ePRO prototypes to create and refine the electronic symptom management system eSyM

Detailed description

A multi-disciplinary team of investigators from 6 health systems have formed the Symptom Management IMplementation of Patient Reported Outcomes in Oncology (SIMPRO) Research Center. SIMPRO will use functioning ePRO prototypes to create and refine the electronic symptom management system eSyM. eSyM is the name of the platform the team will refine, integrate, implement and evaluate. eSyM addresses each of the 4 evidence gaps by: * Implementing eSyM in cancer centers in small, rural or community-based systems. * Integrating eSyM into the EHR (electronic health record) of the predominant vendor used nationwide. * Leveraging evidence-based tools, patient engagement, and population management. * Executing this work using the Consolidated Framework for Implementation Research across all phases to maximize the chances that eSyM and similar systems achieve their intended goals and decrease the morbidity of cancer treatment at a population level. This project contains 5 activities: 1. Obtain stakeholder feedback 2. Build and deploy eSyM 3. Pilot test eSyM 4. Pragmatic stepped-wedge cluster randomized trial 5. Integration of eSyM data to develop algorithms to estimate the risk of experiencing an outcome, including, but not limited to, ED usage and hospitalization among cancer patients

Conditions

• Other Cancer
• Gastrointestinal Cancer
• Thoracic Cancer
• Gynecologic Cancer

Interventions

Type	Name	Description
OTHER	Stakeholder Survey (Control Period)	Before eSyM go-live, study team members from each site will solicit input via emailed survey, remote meetings and/or in-person meeting on the use of ePROs in oncology from stakeholders to obtain input regarding adaptation, anticipated challenges, and implementation.
OTHER	Stakeholder Survey (Intervention Period)	After eSyM go-live and on an ongoing basis, we will evaluate the implementation process at each of the sites with a focus on adoption, appropriateness, acceptability, sustainability, penetration, and scalability. We will do so through emailed surveys and/or discussions with health system leadership, clinicians, clinic support staff, and informatics/IT staff.
OTHER	Qualitative Interview	A small subset of patients and stakeholders were invited to take part in qualitative interviews after the eSyM trial rollout.
OTHER	SASS Questionnaire	A subset of control and intervention patients will be asked to complete a research questionnaire called the "SASS Questionnaire" asking about their Self-efficacy, Attainment of information needs, Symptom burden, and Satisfaction with care.
OTHER	eSyM	The electronic symptom management (eSyM) program is the EHR-integrated ePRO program being evaluated through this trial.

Timeline

• Start date: 2019-07-25
• Primary completion: 2023-03-31
• Completion: 2025-06-09
• First posted: 2019-02-22
• Last updated: 2025-08-27
• Results posted: 2025-08-27

Locations

6 sites across 1 country: United States