← Back to Search

Electronic Symptom Management for Cancer (SIMPRO Trial)

N/A

Waitlist Available

Led By Deborah Schrag, MD, MPH

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Suspected thoracic cancer [lung or bronchus] AND is inpatient following thoracic surgery.

Diagnosis of gastrointestinal cancer [colorectal, pancreas, liver/biliary, esophagus,or gastric] AND scheduled to start a new treatment plan for gastrointestinal cancer.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-year medical record abstraction

Awards & highlights

SIMPRO Trial Summary

This trial will test whether an electronic symptom management system can help cancer patients by reducing symptom burden, improving quality of life, and reducing acute care.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial involves questionnaires and app usage rather than medication or invasive procedures, traditional side effects are not applicable. However, there may be emotional or psychological impacts from regular self-reporting of symptoms.

SIMPRO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

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

Select...

I am hospitalized after surgery for suspected gastrointestinal cancer.

Select...

I have been diagnosed with cancer of the ovary, uterus, or cervix and am about to start a new treatment.

Select...

I am 18 years old or older.

Select...

I am hospitalized after surgery for suspected ovarian, uterine, or cervical cancer.

SIMPRO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-year medical record abstraction

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1-year medical record abstraction

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-year medical record abstraction for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

'Emergency Department - Treat and Release' (EDTR) Rate at 30-days

Secondary outcome measures

Impact on initiation of adjuvant chemotherapy and chemotherapy duration assessed at 1 year

Patients' outcomes, indicated by levels of self-efficacy and symptom burden, at day 30 of eSyM usage

Patients' satisfaction with their cancer care at 30-days post-chemo start or post-surgery: AHRQ's CAHPS Analysis Program

+2 more

SIMPRO Trial Design

5Treatment groups

Experimental Treatment

Active Control

Group I: Activity 4: eSyM- ParticipantsExperimental Treatment1 Intervention

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

Group II: Activity 4: eSyM+ ParticipantsExperimental Treatment2 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 Questionnaire (eSyM+ version or eSyM-Non-Responder version)" A medical record abstraction will be completed for ALL eSyM+ patients

Group III: Activity 3: Pilot Test eSyM AppExperimental Treatment1 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 BuildActive Control1 Intervention

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

Group V: Activity 1: Stakeholder FeedbackActive Control1 Intervention

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

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,908,153 Total Patients Enrolled

Dana-Farber Cancer InstituteLead Sponsor

1,078 Previous Clinical Trials

315,872 Total Patients Enrolled

Dartmouth-Hitchcock Medical CenterOTHER

524 Previous Clinical Trials

2,518,341 Total Patients Enrolled

Media Library

eSyM App Usage Clinical Trial Eligibility Overview. Trial Name: NCT03850912 — N/A

Gastrointestinal Cancer Research Study Groups: Activity 2: eSym Build, Activity 1: Stakeholder Feedback, Activity 4: eSyM+ Participants, Activity 3: Pilot Test eSyM App, Activity 4: eSyM- Participants

Gastrointestinal Cancer Clinical Trial 2023: eSyM App Usage Highlights & Side Effects. Trial Name: NCT03850912 — N/A

eSyM App Usage 2023 Treatment Timeline for Medical Study. Trial Name: NCT03850912 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants is the clinical trial enrolling at this time?

"Affirmative. The clinicaltrials.gov database confirms that this research endeavour, which was launched on July 25th 2019, is currently looking for applicants. Around 18000 participants need to be acquired from 6 distinct medical centres."

Answered by AI

What is the geographic breadth of this clinical trial?

"This clinical trial has 6 active recruitment sites, including West virginia University Medical Center in Morgantown, Maine Medical Center in Portland and the renowned Dana Farber Cancer Institute situated in Boston."

Answered by AI

Does this research endeavor accept new participants at present?

"Data hosted on clinicaltrials.gov suggests that this research study is recruiting patients, having first been posted in July of 2019 and most recently updated in November of 2022."

Answered by AI