CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 42,808 enrolled
Drug / intervention
Stakeholder Survey (Control Period) +4 moreother
Likely dose
Not stated in record
Key inclusion· 4
  • Age ≥18 years
  • Stakeholder participants (patient advisory council members, health system leaders, clinicians, clinic staff, IT/informatics staff) OR patients with suspected thoracic, gastrointestinal, or gynecologic cancer undergoing surgery OR patients with confirmed thoracic, gastrointestinal, or gynecologic cancer starting new treatment
  • Priority patient populations include those with suspected/confirmed thoracic cancer (lung/bronchus), gastrointestinal cancer (colorectal, pancreas, liver/biliary, esophagus, gastric), or gynecologic cancer (ovary, uterus, cervix)
  • Any patient at any participating site may use eSyM (total population)
Key exclusion· 1
  • Participants not meeting inclusion criteria

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03850912
NCT03850912N/ACompleted

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

Dana-Farber Cancer Institute·interventional·Posted Feb 22, 2019·Updated Aug 27, 2025

In Brief

A clinical study evaluating Stakeholder Survey (Control Period), Stakeholder Survey (Intervention Period), and 3 other interventions for Other Cancer and 3 related conditions. Completed, enrolled 42,808 participants across 6 sites.

Detailed 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

Study Details

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedFeb 22, 2019
Enrollment StartJul 25, 2019
Primary CompletionMar 31, 2023
Study CompletionJun 9, 2025
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 7.4 years ago

Interventions

Stakeholder Survey (Control Period)other

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.

Stakeholder Survey (Intervention Period)other

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.

Qualitative Interviewother

A small subset of patients and stakeholders were invited to take part in qualitative interviews after the eSyM trial rollout.

SASS Questionnaireother

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.

eSyMother

The electronic symptom management (eSyM) program is the EHR-integrated ePRO program being evaluated through this trial.