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

216 Participants Needed

Trial Summary

What is the purpose of this trial?

This proposed study plans to develop and evaluate a patient-oriented, technology-based, symptom monitoring system that reports symptoms experienced by children with cancer to their parents and health care providers.

Research Team

Jin-Shei Lai, PhD

Principal Investigator

Northwestern University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+