Electronic Symptom Management for Cancer

(SIMPRO Trial)

No longer recruiting at 6 trial locations

Overseen By Michael Hassett, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: None specified

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new app called eSyM, designed to help cancer patients manage symptoms more effectively using their smartphones. The goal is to reduce symptom burden and improve quality of life by proactively tracking symptoms and providing feedback. Suitable participants include those who have undergone or are scheduled for surgery or a new treatment plan for thoracic, gastrointestinal, or gynecologic cancers. The trial includes various groups, such as those providing feedback and those actively using the app, to refine its functionality. As an unphased trial, this study offers patients the opportunity to contribute to innovative solutions that could enhance cancer care.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It would be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the eSyM app and SASS Questionnaire are safe for cancer symptom management?

Research has shown that mobile apps like the eSyM app are safe for cancer patients. These apps assist patients in tracking symptoms, adhering to treatment plans, and recognizing when to seek help. Studies have found that these apps are user-friendly and improve symptom management. No major reports of negative effects have emerged from using these apps. Therefore, patients can feel confident about the safety of using the eSyM app. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Electronic Symptom Management (eSyM) app because it offers a new way to manage cancer symptoms by using digital technology. Unlike traditional methods that rely heavily on in-person consultations, eSyM allows patients to track and report their symptoms in real-time through a user-friendly app. This innovative approach can lead to more timely interventions, potentially improving patient outcomes and satisfaction. Additionally, the app aims to enhance communication between patients and healthcare providers, making symptom management more efficient and personalized.

What evidence suggests that the eSyM app is effective for managing cancer symptoms?

Research has shown that electronic tools for symptom monitoring can greatly enhance the quality of life for cancer patients. One study found that lung cancer patients using these tools experienced better health-related quality of life. Other studies have demonstrated that patients using electronic patient-reported outcomes (ePROs) manage their symptoms more effectively and have fewer hospital visits. In this trial, the eSyM app serves as an intervention to help patients track symptoms, find management tips, and receive alerts, potentially leading to better overall health. This proactive symptom tracking shows promise in reducing symptoms and improving cancer care. ^{1 2 6 7 8}

Who Is on the Research Team?

Michael Hassett, MD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Stakeholder Feedback

Obtain stakeholder feedback to inform eSyM finalization and implementation

4-6 weeks

Build and Deploy eSyM

Build and deploy the eSyM system and finalize training materials

8-12 weeks

Pilot Test eSyM

Pilot testing of the eSyM app including user acceptability testing and medical record abstraction

12 weeks

Pragmatic Stepped-Wedge Cluster Randomized Trial

Conduct a stepped-wedge cluster randomized trial to evaluate eSyM

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

• eSyM App Usage
• SASS Questionnaire

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.

How Is the Trial Designed?

Group I: Stakeholder Qualitative Interviews Experimental Treatment 1 Intervention

A subset of eligible stakeholders at each site were asked to participate in a one-time interview to provide feedback on facilitators and barriers to eSyM implementation and adoption after the roll-out of eSyM.

Group II: Stakeholder Feedback (Intervention Period) Experimental Treatment 1 Intervention

Eligible stakeholders at each SIMPRO site were invited to provide feedback through surveys after the trial rollout of eSyM to inform intervention normalization and sustainability. Stakeholders included: * health system leaders * clinicians * clinic support staff/administration * IT/Informatics

Group III: Stakeholder Feedback (Control Period) Experimental Treatment 1 Intervention

Eligible stakeholders at each SIMPRO site were invited to provide feedback through focus groups, team meetings, and surveys before the trial rollout of eSyM to inform development and implementation. Stakeholders included: * patient advisory councils * health system leaders * clinicians * clinic support staff/administration * IT/Informatics

Group IV: SASS Questionnaire Participants (Intervention Period) Experimental Treatment 1 Intervention

A subset of trial intervention patients were asked to complete a research questionnaire called the SASS Questionnaire after the roll-out of eSyM to assess patient outcomes including self-efficacy, attainment of informational needs, symptom burden, and satisfaction with care.

Group V: SASS Questionnaire Participants (Control Period) Experimental Treatment 1 Intervention

A subset of trial control patients were asked to complete a research questionnaire called the SASS Questionnaire before the roll-out of eSyM to assess patient outcomes including self-efficacy, attainment of informational needs, symptom burden, and satisfaction with care.

Group VI: Pilot Testing Experimental Treatment 1 Intervention

A subset of control patients at each site were selected to pilot test the eSyM intervention prior to trial start.

Group VII: Patient Qualitative Interviews Experimental Treatment 1 Intervention

A subset of trial intervention patients were asked to participate in a one-time patient interview to provide feedback on facilitators and barriers to eSyM implementation and adoption after the roll-out of eSyM.

Group VIII: Cluster Randomized Trial (Intervention Patients) Experimental Treatment 1 Intervention

These patients (and/or proxy) were seen at a participating site after the trial rollout of eSyM and were exposed to the eSyM intervention.

Group IX: Cluster Randomized Trial (Control Patients) Active Control 1 Intervention

These patients (and/or proxy) were seen at a participating site prior to the trial rollout of eSyM and were not exposed to the eSyM intervention.

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dartmouth-Hitchcock Medical Center

Collaborator

Trials

548

Recruited

2,545,000+

RTI International

Collaborator

Trials

201

Recruited

942,000+

Lifespan

Collaborator

Trials

43

Recruited

41,100+

West Virginia University

Collaborator

Trials

192

Recruited

64,700+

Baptist Memorial Health Care Corporation

Collaborator

Trials

6

Recruited

28,700+

MaineHealth

Collaborator

Trials

76

Recruited

43,800+

Published Research Related to This Trial

The implementation of electronic patient-reported outcomes (ePROs) in a large community oncology network showed high initial utilization, with 73% of enrolled patients completing at least one assessment, indicating that ePROs can effectively monitor symptoms during chemotherapy.

However, compliance with ePRO assessments declined over time, from 72% to 52% over 10 weeks, highlighting the need to address barriers such as reminder prompts and clinician engagement to maintain high levels of participation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of Electronic Patient-Reported Outcomes for Symptom Monitoring in a Large Multisite Community Oncology Practice: Dancing the Texas Two-Step Through a Pandemic. Patt, D., Wilfong, L., Hudson, KE., et al.[2022]

The mobile phone-based Advanced Symptom Management System (ASyMS) significantly reduced reports of fatigue and hand-foot syndrome in patients undergoing chemotherapy compared to a control group, indicating its efficacy in symptom management.

In a randomized controlled trial involving 112 cancer patients, those using ASyMS reported better management of chemotherapy-related symptoms, suggesting that remote monitoring can enhance patient care during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a mobile phone-based, advanced symptom management system (ASyMS) in the management of chemotherapy-related toxicity. Kearney, N., McCann, L., Norrie, J., et al.[2022]

The eSMART study will involve 1108 oncology patients starting first-line chemotherapy across five European countries, aiming to evaluate the effectiveness of the ASyMS remote symptom monitoring system compared to standard care.

The primary outcome will focus on symptom burden, while secondary outcomes will assess quality of life, supportive care needs, and cost-effectiveness, addressing previous methodological weaknesses in similar studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The eSMART study protocol: a randomised controlled trial to evaluate electronic symptom management using the advanced symptom management system (ASyMS) remote technology for patients with cancer. Maguire, R., Fox, PA., McCann, L., et al.[2019]

A pilot study involving 40 women with breast cancer showed that using a symptom management mobile application alongside usual care led to better quality of life and lower severity of depression compared to those receiving only usual care.

The intervention group experienced less decline in general health and physical functioning during chemotherapy, suggesting that the mobile app may effectively support emotional and physical well-being during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mobile Application for Symptom Management in Patients With Breast Cancer. Seven, M., Paşalak, Ş., Bagcivan, G., et al.[2022]

Citations

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pmc.ncbi.nlm.nih.gov

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The meta-analysis showed significant improvement in health-related quality of life (SMD = 2.44, P < 0.001) among patients with lung cancer.

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This study assesses the feasibility and efficacy of the SUPPORT+ app for monitoring symptoms and providing timely interventions for patients with advanced ...

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Mobile apps are increasingly used in oncology to support patients' health by improving self-management, symptom tracking, medication adherence, ...