Symptom Monitoring System for Childhood Cancer

(SyMon-SAYS Trial)

Overseen By Jin-Shei Lai, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Non-English speakers

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 tests a new system called SyMon-SAYS, designed to help kids with cancer report their symptoms easily. The system keeps parents and healthcare providers informed about the child's experiences. Participants will either use the system immediately or after a short waiting period. Children with cancer who are currently receiving treatment or finished it within the last 6 months, and who can use a smartphone or computer, might be a good fit for this trial. As an unphased trial, this study offers a unique opportunity for participants to contribute to innovative solutions that could improve symptom management for children with cancer.

Do I need to stop my current medications for this trial?

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

What prior data suggests that this symptom monitoring system is safe for children with cancer?

Research has shown that the SyMon-SAYS system helps track and report symptoms in children with cancer. This tool collects symptom information directly from patients and shares it with their healthcare team. In one study, the system connected to the hospital's electronic health record (EHR), allowing doctors to receive symptom alerts easily. As a result, doctors took action about half of the time.

SyMon-SAYS aims to improve communication and care, not to serve as a medication or treatment that might cause side effects. So far, no negative effects have been reported from using the system. Instead, it appears to enhance symptom management by keeping healthcare providers informed, potentially leading to improved care for young patients with cancer symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Symptom Monitoring System for Childhood Cancer, known as SyMon-SAYS, because it offers a novel approach to managing symptoms in young cancer patients. Unlike traditional treatments focusing on medication or therapy, SyMon-SAYS uses an interactive system to actively monitor and address symptoms on a weekly basis. This proactive and regular engagement aims to improve patient well-being and quality of life by promptly identifying and managing symptoms. By shifting the focus to continuous symptom management, SyMon-SAYS has the potential to enhance overall care for children with cancer.

What evidence suggests that the SyMon-SAYS system is effective for symptom monitoring in childhood cancer?

Research has shown that the SyMon-SAYS system helps parents manage their child's cancer symptoms more effectively. In this trial, participants in Group A will receive the SyMon-SAYS intervention weekly for 16 weeks, while those in Group B will receive usual care initially and then the intervention during weeks 9-16. Studies have found that the system eases the challenges parents face in dealing with these symptoms. In one study, the system led to changes in medical care in over half of the reported cases, demonstrating real improvements. Additionally, the system increases user satisfaction by integrating well with current healthcare technology. Overall, early findings suggest that SyMon-SAYS could be a valuable tool for families managing cancer symptoms. ^{1 4 6 7 8}

Who Is on the Research Team?

Jin-Shei Lai, PhD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

This trial is for children aged 8-17 with cancer, including brain tumors, who are currently receiving treatment or have completed therapy within the last 6 months. They must be able to understand and use English to give consent and interact with a symptom monitoring system on an electronic device.

Inclusion Criteria

Parent/legal guardian must be a parent (father or mother) or a legal guardian of eligible patients

I can use a smartphone or computer to complete surveys.

I can use a smartphone or computer to complete surveys.

Exclusion Criteria

Parents or patients who cannot understand English sufficiently to sign consent/assent form

Parents or patients who cannot understand English sufficiently to complete the questionnaires

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Group A participants receive the SyMon-SAYS intervention every week for 16 weeks. Group B participants receive usual care for 8 weeks, then the intervention for 8 weeks.

16 weeks

Weekly assessments

Follow-up

Participants are monitored for changes in symptom management barriers, symptom burden, HRQOL, and self-efficacy.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SyMon-SAYS

Trial Overview The study is testing SyMon-SAYS, a technology-based system designed to track and report symptoms of young cancer survivors. It aims to improve communication between children living with cancer, their parents, and healthcare providers.

How Is the Trial Designed?

Group I: SyMon-SAYS Waitlist Control (Group B) Experimental Treatment 1 Intervention

The waitlist control group participants (Group B) will receive their usual care during weeks 1-8 and will receive the SyMon-SAYS intervention every week during weeks 9-16.

Group II: SyMon-SAYS Intervention (Group A) Experimental Treatment 1 Intervention

Group A participants will receive the SyMon-SAYS intervention every week for 16 weeks.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Ann & Robert H Lurie Children's Hospital of Chicago

Collaborator

Trials

275

Recruited

5,182,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10517385/

Using IT to Improve Outcomes for Children Living With Cancer ... In this randomized trial, we are examining the effects of the SyMon-SAYS system on perceived barriers to symptom management, self-efficacy, and symptom severity ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37682593/

Using IT to Improve Outcomes for Children Living With Cancer ... Objective: In this randomized trial, we are examining the effects of the SyMon-SAYS system on perceived barriers to symptom management, self- ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04789720

Using Information Technology to Improve Outcomes for ... We hypothesize that the SyMon-SAYS intervention will decrease parent-perceived barriers to managing their child's symptoms, decrease patient symptom burden, ...

4. researchgate.net researchgate.net/publication/373790323_Using_IT_to_Improve_Outcomes_for_Children_Living_With_Cancer_SyMon-SAYS_Protocol_for_a_Single-Institution_Waitlist_Randomized_Controlled_Trial_Preprint

Using IT to Improve Outcomes for Children Living With ... Objective: In this randomized trial, we are examining the effects of the SyMon-SAYS system on perceived barriers to symptom management, self-efficacy, and ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/pbc.32106

Enhancing Circle‐of‐Care Communication in Pediatric ... SyMon-SAYS integrated with Epic, generating 339 alerts over 16 weeks, prompting clinical action 52% of the time, and boosting user satisfaction ...

6. academic.oup.com academic.oup.com/neuro-oncology/article/24/Supplement_1/i135/6601275

QOL-09. SyMon-SAYS: A symptom monitoring and reporting ... SyMon-SAYS is a technology-based program with the potential to minimize symptom management barriers by routinely collecting and interpreting ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5845473/

Symptom Monitoring in Pediatric Oncology using Patient ... Symptom monitoring using patient-reported outcomes (PROs) is not common in pediatric oncology, despite interest from stakeholders, including patients, families, ...

8. unclineberger.org unclineberger.org/news/consortium-addresses-health-risks-associated-with-radiation-therapy-for-childhood-cancers/

Consortium addresses health risks associated with ... The National Cancer Institute reports that 60% to 90% of childhood cancer survivors develop one or more chronic health issues in adulthood, and ...