Symptom Management Implementation of Patient Reported Outcomes in Oncology

NCT03850912 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42808

Last updated 2025-08-27

Study results available
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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

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
  • Dana-Farber Cancer Institute

    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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03850912 on ClinicalTrials.gov