Abstract
Background: People with cancer experience symptoms that adversely affect quality of life. Despite existing interventions and clinical guidelines, timely symptom management remains uneven in oncology care. We describe a study to implement and evaluate an electronic health record (EHR)-integrated symptom monitoring and management program in adult outpatient cancer care. Methods: Our cancer patient-reported outcomes (cPRO) symptom monitoring and management program is a customized EHR-integrated installation. We will implement cPRO across all Northwestern Memorial HealthCare (NMHC) hematology/oncology clinics. We will conduct a cluster randomized modified stepped-wedge trial to evaluate patient and clinician engagement with cPRO. Further, we will embed a patient-level randomized clinical trial to evaluate the impact of an additional enhanced care (EC; cPRO plus web-based symptom self-management intervention) relative to usual care (UC; cPRO alone). The project uses a Type 2 hybrid effectiveness-implementation approach. The intervention will be implemented across seven regional clusters within the healthcare system comprising 32 clinic sites. A 6-month prospective pre-implementation enrollment period will be followed by a post-implementation enrollment period, during which newly enrolled, consenting patients will be randomly assigned (1:1) to EC or UC. We will follow patients for 12 months post-enrollment. Patients randomized to EC will receive evidence-based symptom-management content on cancer-related concerns and approaches to enhance quality of life, using a web-based tool (“MyNM Care Corner”). This design allows for within- and between-site evaluation of implementation plus a group-based comparison to demonstrate effectiveness on patient-level outcomes. Discussion: The project has potential to guide implementation of future healthcare system-level cancer symptom management programs. http://ClinicalTrials.gov
Original language | English (US) |
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Article number | 107171 |
Journal | Contemporary Clinical Trials |
Volume | 128 |
DOIs | |
State | Published - May 2023 |
Funding
REDCap is supported by the Northwestern University Clinical and Translational Science (NUCATS) Institute. Research reported in this publication was supported, in part, by the National Institutes of Health's National Center for Advancing Translational Sciences , Grant Number UL1TR001422 . The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health The Improving the Management of symPtoms during And following Cancer Treatment (IMPACT) Consortium is a Cancer Moonshot Research Initiative under the authorization of the 2016 United States 21st Century Cures Act. Research reported in this publication was supported by the National Cancer Institute of the National Institutes of Health under Award Number UM1CA233035 to D. Cella. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Keywords
- Cancer
- Electronic health record
- Implementation science
- Patient engagement
- Patient-reported outcomes
- Symptom management
ASJC Scopus subject areas
- Pharmacology (medical)