216 Participants Needed

Symptom Monitoring System for Childhood Cancer

(SyMon-SAYS Trial)

VV
JL
Overseen ByJin-Shei Lai, PhD
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Northwestern University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

JL

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.
See 6 more

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
2Treatment groups
Experimental Treatment
Group I: SyMon-SAYS Waitlist Control (Group B)Experimental Treatment1 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 Treatment1 Intervention
Group A participants will receive the SyMon-SAYS intervention every week for 16 weeks.

Find a Clinic Near You

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+
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