What side effects are associated with this type of intervention?

Common treatments for gastrointestinal cancer, such as chemotherapy and targeted therapies, often come with a range of side effects. These can include fatigue, nausea, diarrhea, constipation, and decreased appetite. More severe side effects may involve immune-mediated reactions like colitis and hepatitis, as well as other issues such as pneumonitis, thyroid disorders, and infusion-related reactions. Monitoring these symptoms electronically can help manage and mitigate their impact on patients' quality of life.

What prior FDA approvals exist?

The FDA has approved several treatments for gastrointestinal cancers, particularly those involving systemic therapies and monoclonal antibodies. Pembrolizumab, an anti-PD-1 monoclonal antibody, has shown efficacy in treating esophageal squamous cell carcinoma, as demonstrated in the KEYNOTE-181 trial. Another PD-1 inhibitor, avelumab, was evaluated in the JAVELIN Gastric 300 trial for patients with advanced gastric cancer. These treatments align with the systemic therapy approach and symptom management strategies being explored in the ePRO Monitoring trial.

What other types of research exist?

Promising novel alternatives to ePRO monitoring for gastrointestinal cancer patients include: 1) Liquid biopsy technologies, such as circulating tumor DNA (ctDNA) analysis, which allow for non-invasive monitoring of tumor dynamics and treatment response. 2) Advanced endoscopic techniques with integrated artificial intelligence (AI) for real-time assessment and monitoring of gastrointestinal lesions. 3) Implementation of comprehensive endoscopic electronic medical records (EEMRs) to streamline data collection and enhance clinical decision-making. 4) Continuous quality monitoring systems for endoscopy, such as ADR50 monitoring, to ensure high standards in diagnostic procedures.

← 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

No Placebo-Only Group

Summary

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.

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.

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.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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 (Agency for Healthcare Research and Quality) CAHPS (Consumer Assessment of Healthcare Providers & Systems) Analysis Program

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Active Control

Group I: Activity 4: eSyM- ParticipantsExperimental Treatment2 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+ ParticipantsExperimental Treatment3 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 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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for gastrointestinal cancer include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cancer cells, but it can also affect healthy cells, leading to significant side effects. Targeted therapy involves drugs that specifically target cancer cell molecules, such as HER2 in some gastric cancers, thereby minimizing damage to normal cells. Immunotherapy boosts the body's immune system to recognize and destroy cancer cells. Effective symptom management, including electronic symptom tracking and feedback (ePRO), is crucial for these patients as it helps in early detection and management of side effects, improving quality of life and potentially extending survival.

Highlights from the 2022 ASCO gastrointestinal cancer symposium: An overview by the EORTC gastrointestinal tract cancer group.Potential molecular targets for Ewing's sarcoma therapy.Exposure to sodium channel-inhibiting drugs and cancer survival: protocol for a cohort study using the QResearch primary care database.