Symptom Management Implementation of Patient Reported Outcomes in Oncology (SIMPRO)

June 20, 2023 updated by: Michael Hassett, MD, Dana-Farber Cancer Institute

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

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 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 4 activities:

  1. Obtain stakeholder feedback
  2. Build and deploy eSyM
  3. Pilot test eSyM
  4. Pragmatic stepped-wedge cluster randomized trial

Study Type

Interventional

Enrollment (Estimated)

25000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Maine
      • Portland, Maine, United States, 04101
        • Maine Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana Farber Cancer Institute
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Lifespan
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Baptist Memoiral HealthCare
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Activity 1: Stakeholder Feedback

Obtain stakeholder feedback to inform eSyM finalization and implementation from:

  • patient advisory councils
  • health system leaders
  • clinicians
  • clinic support staff/administration
  • IT/Informatics
No Intervention: Activity 2: eSym Build
  • Build and deploy eSyM
  • Finalize training materials based on findings from stakeholder engagement
Experimental: Activity 3: Pilot Test eSyM App

Pilot testing of the eSyM app will include:

  • Activity 3a (eSyM app usage by patients)
  • Activity 3b (User acceptability testing)
  • Activity 3c (Medical record abstraction)
Other: eSyM App Usage
Patients (and/or proxy) will report their cancer-related symptoms and receive tailored feedback via eSyM
Experimental: Activity 4: eSyM+ Participants
  • These patients (and/or proxy) will report their symptoms in eSyM
  • A subset of these patients will be asked to complete a research questionnaire called the "SASS Questionnaire (eSyM+ version or eSyM-Non-Responder version)"
  • A medical record abstraction will be completed for ALL eSyM+ patients
Other: eSyM App Usage
Patients (and/or proxy) will report their cancer-related symptoms and receive tailored feedback via eSyM
Other: SASS Questionnaire
A subset of eSyM+ and eSyM- 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 (see PROMIS, CAHPS, IAM/AIM question banks - Appendices C through G). The questionnaire will stop being administered once 1800 total surveys have been received.
Experimental: Activity 4: eSyM- Participants
  • These patients (and/or proxy) will NOT report their symptoms in eSyM
  • A subset of these patients will be asked to complete a research questionnaire called the "SASS Questionnaire (eSyM- version)"
  • A medical record abstraction will be completed for ALL eSyM- patients
Other: SASS Questionnaire
A subset of eSyM+ and eSyM- 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 (see PROMIS, CAHPS, IAM/AIM question banks - Appendices C through G). The questionnaire will stop being administered once 1800 total surveys have been received.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
'Emergency Department - Treat and Release' (EDTR) Rate at 30-days
Time Frame: 30 days

The primary study outcome of the stepped wedge cluster RCT is the EDTR rate. This outcome will be defined in relation to the date of discharge from hospital (surgical oncology) or the initiation date of a new intravenous chemo regimen (medical oncology). The investigators will evaluate the # of EDTR visits for patients using the eSyM app.

30-day EDTR rates are estimated to vary between 8% to 15% for the control group. The investigators hypothesize that EDTR rates will be 3-4% lower in the eSyM+ group. Control group rates were estimated based on EDTR rates derived from HCUP data, institutional data and early phase analyses from CMMI's Oncology Care Model for Baptist Memorial, the only Oncology Care Model participant among our 6 sites.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients' outcomes, indicated by levels of self-efficacy and symptom burden, at day 30 of eSyM usage
Time Frame: One time survey (30-60 days after surgery or first dose of chemo)
Patients (both Surg Onc and Med Onc) from each of the 6 sites will be surveyed in the period before and after rollout according to the stepped wedge design schema. Assuming a 75% response rate, the investigators expect to survey 400 patients per site (2400 total) to obtain 300 (1800 total) responses split evenly between eSyM+ and eSyM- subjects. Additional survey participants can readily be identified if the 75% response rate is not achieved. Yost and Cella have reported minimally important difference (MID) ranges for five PROMIS domains including fatigue, pain, depression, anxiety, and physical functioning217, 130 Cella recommends using 0.5 SD as the MID for PROMIS scales218,219.
One time survey (30-60 days after surgery or first dose of chemo)
Patients' satisfaction with their cancer care at 30-days post-chemo start or post-surgery: AHRQ's CAHPS Analysis Program
Time Frame: One time survey (30-60 days after surgery or first dose of chemo)
The investigators will use the AHRQ's CAHPS Analysis Program to compare scores for eSyM+ and eSyM-, adjusting for case mix. Table Aim 2d (in the protocol) shows differences in satisfaction scores the investigators can detect with 80% power. For example, with 360 patients (e.g., those who have GI surgery) the investigators have >80% power to detect effect size >0.44, a meaningful difference in CAHPS scores. Patients will complete a subset of the CAHPS Cancer Care Survey. Items assessed will include: cancer care delivery, patient experience, and patient satisfaction. Responses will be assessed through the following options: a) (Never, Sometimes, Usually, Always) b) (Yes, definitely, Yes, somewhat, No) c) 0-10.
One time survey (30-60 days after surgery or first dose of chemo)
eSyM sustainability at the patient, clinic and health system level
Time Frame: 1-year medical record abstraction
The investigators will be evaluating patient adoption rates and clinician usage rates by analyzing EHR data based on eSyM utilization patterns. Appropriateness and acceptability will be ascertained using Weiner's IAM and AIM surveys (8-items total, less than 3 minutes to complete) which will be administered along with CAHPS surveys. Appropriateness and acceptability ratings will be defined based on the % of respondents who "agree" or "completely agree" with the survey items compared to the % who are neutral, disagree, or completely disagree and characterized using descriptive statistics.81
1-year medical record abstraction
Impact on initiation of adjuvant chemotherapy and chemotherapy duration assessed at 1 year
Time Frame: 1-year medical record abstraction

The investigators will be using the EMR to evaluate the timing of first dose to the last dose of a specific chemotherapy regimen. The investigators expect that patients exposed to eSyM may be able to: 1) initiate adjuvant therapy sooner; 2) remain on their chemotherapy regimens for longer duration. These time intervals are straightforward to measure from EHR encounter and date fields.

For medical oncology patients, the outcome is time from the first dose to the last dose of a specific regimen. The investigators will censor follow-up at 1 year. The investigators will use generalized linear mixed-effect models to compare treatment duration for eSyM+ vs. eSyM- patients. For surgical oncology patients, the denominator population consists of patients who receive any adjuvant chemotherapy within 6 postoperative months. Tumor registry stage distribution at our 6 sites indicates that this will be 202 patients per site or 1212 in total.
1-year medical record abstraction
Sustainability of ePRO symptom management within a health system
Time Frame: 1-year medical record abstraction
The investigators will evaluate sustainability at the patient, clinic and health system level using simple rates and proportions. To evaluate sustainability, the investigators will examine the consequences of withdrawing grant-funded nursing support for symptom management in the post-implementation period. The investigators will compare outcomes from Period 6 (study month 45-50, all sites eSyM+) and the post-Implementation (Post-I; study months 51-56). Sites are trained and empowered to manage eSyM autonomously without research study staff. Then, during post-implementation, dedicated nursing support to monitor eSyM is tapered in half the sites (see Figure C2). To examine whether backing off on the study support attenuates the effect, the investigators will perform difference in difference analysis.
1-year medical record abstraction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

National Cancer Institute (NCI)
Dartmouth-Hitchcock Medical Center
West Virginia University
RTI International
MaineHealth
Lifespan
Baptist Memorial Health Care Corporation

Investigators

  • Principal Investigator: Michael Hassett, MD, Dana-Farber Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 25, 2019

Primary Completion (Actual)

March 31, 2023

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

February 20, 2019

First Submitted That Met QC Criteria

February 21, 2019

First Posted (Actual)

February 22, 2019

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 20, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-734
  • 1UM1CA233080-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research data set used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research

IPD Sharing Time Frame

Data can be shared no earlier than 1 year following the date of publication

IPD Sharing Access Criteria

DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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