Electronic Symptom Management for Cancer

(SIMPRO Trial)

Recruiting at5 trial locations

Overseen by Michael Hassett, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Dana-Farber Cancer Institute

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial aims to improve symptom management for cancer patients using a digital tool called eSyM. Patients report their symptoms through an app, and this information is shared with their healthcare providers. The goal is to help doctors and nurses manage symptoms more effectively, especially for patients in rural or community-based health systems.

Research Team

Michael Hassett, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

This trial is for adults with thoracic, gastrointestinal, or gynecologic cancers who are starting a new treatment plan. It includes patients inpatient after surgery for suspected cancer in these areas. All participants must be at participating sites and over 18 years old.

Inclusion Criteria

I am in the hospital after surgery for suspected lung cancer.

, and other researchers The potential stakeholders for this study are patient advisory council members, health system leaders, clinicians, clinic support staff/administration, IT/Informatics staff, and other researchers.

I have been diagnosed with gastrointestinal cancer and am about to start a new treatment.

Treatment Details

Interventions

• eSyM App Usage (Behavioural Intervention)
• SASS Questionnaire (Behavioural Intervention)

Trial Overview The study tests an electronic symptom management system called eSyM, which uses the SASS Questionnaire and eSyM App to track patient-reported outcomes to improve symptom control and overall quality of life during cancer care.

Participant Groups

Group I: Activity 4: eSyM- Participants Experimental Treatment 2 Interventions

* 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 subset of these patients will be invited to take part in follow-up qualitative interviews. * A medical record abstraction will be completed for all eSyM- patients

Group II: Activity 4: eSyM+ Participants Experimental Treatment 3 Interventions

* 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 (Self-Efficacy, Attainment of informational needs, Symptom Burden, and Satisfaction with care) Questionnaire (eSyM+ version or eSyM-Non-Responder version)" * A subset of these patients will be invited to take part in follow-up qualitative interviews. * A medical record abstraction will be completed for all eSyM+ patients

Group III: Activity 3: Pilot Test eSyM App Experimental Treatment 1 Intervention

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)

Group IV: Activity 2: eSym Build Active Control 1 Intervention

* Build and deploy eSyM * Finalize training materials based on findings from stakeholder engagement

Group V: Activity 1: Stakeholder Feedback Active Control 1 Intervention

Obtain stakeholder feedback to inform eSyM finalization and implementation from: * patient advisory councils * health system leaders * clinicians * clinic support staff/administration * IT/Informatics

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Dr. Benjamin L. Ebert

Dana-Farber Cancer Institute

Chief Executive Officer

MD from Harvard Medical School, PhD from Oxford University

Dr. Craig A. Bunnell

Dana-Farber Cancer Institute

Chief Medical Officer since 2012

MD from Harvard Medical School, MPH from Harvard School of Public Health, MBA from MIT Sloan School of Management

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Dartmouth-Hitchcock Medical Center

Collaborator

Trials

548

Recruited

2,545,000+

Jonathan T. Huntington

Dartmouth-Hitchcock Medical Center

Chief Medical Officer since 2024

MD, PhD, MPH

Joanne M. Conroy

Dartmouth-Hitchcock Medical Center

Chief Executive Officer since 2017

MD from Medical University of South Carolina

RTI International

Collaborator

Trials

201

Recruited

942,000+

Dr. Anuja Purohit

RTI International

Chief Medical Officer

MD from Duke University School of Medicine

Tim J. Gabel

RTI International

Chief Executive Officer since 2022

Adjunct appointments at University of Wyoming and UNC Gillings School of Global Public Health

Lifespan

Collaborator

Trials

43

Recruited

41,100+

West Virginia University

Collaborator

Trials

192

Recruited

64,700+

Dr. William P. Petros

West Virginia University

Chief Medical Officer

PharmD from West Virginia University

Dr. Clay B. Marsh

West Virginia University

Chief Executive Officer since 2015

MD from West Virginia University, Bachelor’s in Biology from West Virginia University

Baptist Memorial Health Care Corporation

Collaborator

Trials

6

Recruited

28,700+

MaineHealth

Collaborator

Trials

76

Recruited

43,800+

Dr. Andrew Mueller

MaineHealth

Chief Executive Officer since 2021

MD from University of North Carolina School of Medicine

Dr. Adrian Moran

MaineHealth

Chief Medical and Transformation Officer

MD from University College Dublin, Executive MBA in Healthcare from Brandeis University