Clinical trial NCT03850912: Symptom Management Implementation of Patient Reported Outcomes in Oncology
Official title: SIMPRO Research Center: Integration and Implementation of PROs for Symptom Management in Oncology Practice
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Other Cancer
Gastrointestinal Cancer
Thoracic Cancer
Gynecologic Cancer
Keywords: Other Cancer
Digital health
Patient reported outcomes
Symptom management
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: RTI International
name: Baptist Memorial Health Care Corporation
name: Dartmouth-Hitchcock Medical Center
name: MaineHealth
name: West Virginia University
name: Lifespan
First posted: 2019-02-22
Enrollment: 25000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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

Eligibility criteria: Inclusion Criteria:

Activity 1 Population:

* Age ≥ 18 years
* The potential stakeholders are: patient advisory council members, health system leaders, clinicians, clinic support staff/administration, IT/Informatics staff

Activity 3 Population:

* Age ≥ 18 years
* Priority population will be patients who meet one of the following:

  * Suspected thoracic cancer \[lung or bronchus\] AND is inpatient following thoracic surgery.
  * Suspected gastrointestinal cancer \[colorectal, pancreas, liver/biliary, esophagus,or gastric\] AND is inpatient following gastrointestinal surgery.
  * Suspected gynecologic cancer \[ovary, uterus, or cervix\] AND is inpatient following gynecologic surgery.
  * Diagnosis of thoracic cancer \[lung or bronchus\] AND scheduled to start a new treatment plan for thoracic cancer.
  * Diagnosis of gastrointestinal cancer \[colorectal, pancreas, liver/biliary, esophagus,or gastric\] AND scheduled to start a new treatment plan for gastrointestinal cancer.
  * Diagnosis of gynecologic cancer \[ovary, uterus, or cervix\] AND scheduled to start a new treatment plan for gynecologic cancer.
* Total population allowed to use eSyM:

  * Any patient at any participating site.

Activity 4 Population:

* Age ≥ 18 years
* Priority population will be patients who meet one of the following:

  * Suspected thoracic cancer \[lung or bronchus\] AND is inpatient following thoracic surgery.
  * Suspected gastrointestinal cancer \[colorectal, pancreas, liver/biliary, esophagus,or gastric\] AND is inpatient following gastrointestinal surgery.
  * Suspected gynecologic cancer \[ovary, uterus, or cervix\] AND is inpatient following gynecologic surgery.
  * Diagnosis of thoracic cancer \[lung or bronchus\] AND scheduled to start a new treatment plan for thoracic cancer.
  * Diagnosis of gastrointestinal cancer \[colorectal, pancreas, liver/biliary, esophagus,or gastric\] AND scheduled to start a new treatment plan for gastrointestinal cancer.
  * Diagnosis of gynecologic cancer \[ovary, uterus, or cervix\] AND scheduled to start a new treatment plan for gynecologic cancer.
* Total population allowed to use eSyM:

  * Any patient at any participating site.

Primary outcomes:
measure: 'Emergency Department - Treat and Release' (EDTR) Rate at 30-days
timeFrame: 30 days
Secondary outcomes:
measure: Patients' outcomes, indicated by levels of self-efficacy and symptom burden, at day 30 of eSyM usage
timeFrame: One time survey (30-60 days after surgery or first dose of chemo)
measure: Patients' satisfaction with their cancer care at 30-days post-chemo start or post-surgery: AHRQ's (Agency for Healthcare Research and Quality) CAHPS (Consumer Assessment of Healthcare Providers & Systems) Analysis Program
timeFrame: One time survey (30-60 days after surgery or first dose of chemo)
measure: eSyM sustainability at the patient, clinic and health system level
timeFrame: 1-year medical record abstraction
measure: Impact on initiation of adjuvant chemotherapy and chemotherapy duration assessed at 1 year
timeFrame: 1-year medical record abstraction
measure: Sustainability of ePRO symptom management within a health system
timeFrame: 1-year medical record abstraction
Other outcomes:
Locations:
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Providence
country: United States
facility: Lifespan
state: Rhode Island
city: Memphis
country: United States
facility: Baptist Memoiral HealthCare
state: Tennessee
city: Morgantown
country: United States
facility: West Virginia University Medical Center
state: West Virginia
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Michael Hassett, MD
role: PRINCIPAL_INVESTIGATOR
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citation: Hassett MJ, Wong S, Osarogiagbon RU, Bian J, Dizon DS, Jenkins HH, Uno H, Cronin C, Schrag D; SIMPRO Co-Investigators. Implementation of patient-reported outcomes for symptom management in oncology practice through the SIMPRO research consortium: a protocol for a pragmatic type II hybrid effectiveness-implementation multi-center cluster-randomized stepped wedge trial. Trials. 2022 Jun 16;23(1):506. doi: 10.1186/s13063-022-06435-1.
citation: Hassett MJ, Cronin C, Tsou TC, Wedge J, Bian J, Dizon DS, Hazard-Jenkins H, Osarogiagbon RU, Wong S, Basch E, Austin T, McCleary N, Schrag D. eSyM: An Electronic Health Record-Integrated Patient-Reported Outcomes-Based Cancer Symptom Management Program Used by Six Diverse Health Systems. JCO Clin Cancer Inform. 2022 Jan;6:e2100137. doi: 10.1200/CCI.21.00137.
citation: Paudel R, Enzinger AC, Uno H, Cronin C, Wong SL, Dizon DS, Hazard Jenkins H, Bian J, Osarogiagbon RU, Jensen RE, Mitchell SA, Schrag D, Hassett MJ. Effects of a change in recall period on reporting severe symptoms: an analysis of a pragmatic multisite trial. J Natl Cancer Inst. 2024 Jul 1;116(7):1137-1144. doi: 10.1093/jnci/djae049.
citation: Paudel R, Tramontano AC, Cronin C, Wong SL, Dizon DS, Jenkins HH, Bian J, Osarogiagbon RU, Schrag D, Hassett MJ. Assessing Patient Readiness for an Electronic Patient-Reported Outcome-Based Symptom Management Intervention in a Multisite Study. JCO Oncol Pract. 2024 Jan;20(1):77-84. doi: 10.1200/OP.23.00339. Epub 2023 Nov 27.