Symptom Management Implementation of Patient Reported Outcomes in Oncology
NCT03850912 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42808
Last updated 2025-08-27
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
Conditions
- Other Cancer
- Gastrointestinal Cancer
- Thoracic Cancer
- Gynecologic Cancer
Interventions
- 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.
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
RTI International
collaborator OTHER -
Baptist Memorial Health Care Corporation
collaborator OTHER -
Dartmouth-Hitchcock Medical Center
collaborator OTHER -
MaineHealth
collaborator OTHER -
West Virginia University
collaborator OTHER -
Lifespan
collaborator OTHER - lead OTHER
Principal Investigators
-
Michael Hassett, MD · Dana-Farber Cancer Institute
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-07-25
- Primary Completion
- 2023-03-31
- Completion
- 2025-06-09
Countries
- United States
Study Locations
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