Electronic Symptom Management for Cancer

(SIMPRO Trial)

Recruiting at 5 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

25000 Participants Needed

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.

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 data supports the effectiveness of the eSyM App Usage, SASS Questionnaire treatment for cancer symptom management?

Research on similar mobile applications for cancer patients shows that they can improve communication with healthcare providers, help manage symptoms better, and provide reassurance by monitoring symptoms at home. These tools have been associated with improved quality of life and symptom management in patients undergoing chemotherapy. ^{1 2 3 4 5}

Is the electronic symptom management system safe for use in cancer patients?

The electronic symptom management system (ASyMS) has been used safely in patients with breast, lung, and colorectal cancer to help manage chemotherapy-related symptoms. Patients reported benefits such as improved communication with healthcare providers and better symptom management, with no safety concerns highlighted in the studies. ^{1 2 6 7 8}

How is the electronic symptom management treatment for cancer different from other treatments?

The electronic symptom management treatment, using the Advanced Symptom Management System (ASyMS), is unique because it employs mobile phone technology to remotely monitor and manage chemotherapy-related symptoms in real-time, improving communication with healthcare professionals and providing reassurance to patients managing symptoms at home. ^{2 6 7 8 9}

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.

Timeline

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

Treatment Details

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.

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+

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A Mobile Application for Symptom Management in Patients With Breast Cancer. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Patients' perceptions and experiences of using a mobile phone-based advanced symptom management system (ASyMS) to monitor and manage chemotherapy related toxicity. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Feasibility and User Experience of Digital Patient Monitoring for Real-World Patients With Lung or Breast Cancer. [2023]

4. United States 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. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

The benefits and challenges of using computer-assisted symptom assessments in oncology clinics: results of a qualitative assessment. [2017]

6. Germany pubmed.ncbi.nlm.nih.gov

Evaluation of a mobile phone-based, advanced symptom management system (ASyMS) in the management of chemotherapy-related toxicity. [2022]

7. England 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. [2019]

8. Scotland pubmed.ncbi.nlm.nih.gov

The assessment and management of chemotherapy-related toxicities in patients with breast cancer, colorectal cancer, and Hodgkin's and non-Hodgkin's lymphomas: A scoping review. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Utilization of the Medical Research Council evaluation framework in the development of technology for symptom management: the ASyMS-YG Study. [2015]