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Symptom Screening with Provider Feedback for Pediatric Cancer

Phase 3

Recruiting

Led By Lillian Sung, MD, PhD

Research Sponsored by The Hospital for Sick Children

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Any newly diagnosed cancer

8-18 years of age at enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 8

Awards & highlights

Study Summary

This trial will help researchers understand if using the Symptom Screening in Pediatrics Tool (SSPedi) and the Supportive care Prioritization, Assessment and Recommendations for Kids (SPARK) can help reduce the amount of symptoms children experience while going through cancer treatments.

Who is the study for?

This trial is for children aged 8-18 who have recently been diagnosed with cancer and are starting treatment like chemotherapy or radiotherapy. They must be able to speak English or Spanish, and enroll within 28 days of beginning their treatment. Children with cognitive disabilities not in at least second grade, or those with visual impairments that can't be corrected enough to see the SPARK tool, cannot participate.Check my eligibility

What is being tested?

The study tests a symptom screening process using SSPedi and SPARK tools designed for kids undergoing cancer treatments. It aims to link bothersome symptoms they report to care guidelines that help manage them. The impact on symptom burden, fatigue, and quality of life will be measured by randomizing pediatric cancer centers into this new approach.See study design

What are the potential side effects?

Since this trial focuses on monitoring and managing symptoms rather than testing a drug, there are no direct side effects from interventions being studied. However, it involves regular reporting which could affect participants' routine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been recently diagnosed with cancer.

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I am between 8 and 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 8

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 8 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Symptom Screening in Pediatrics Tool (SSPedi) total score

Secondary outcome measures

Documentation of symptoms

Number of emergency department visits and unplanned clinic visits and hospitalizations

Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Bank v2.0 - Fatigue

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 Intervention

Participants enrolled at intervention sites will be prompted to complete symptom screening three times weekly via SPARK with corresponding feedback and links to symptom management care pathways sent to their healthcare providers. Symptom screening using SPARK can be performed at any time and as often as desired, but screening will be prompted three times weekly for eight weeks. Each day the participant completes symptom screening and has at least one severely bothersome symptom, the primary healthcare team will receive an email summarizing the symptom report and highlighting symptoms that are "a lot" or "extremely" bothersome. Upon study activation, we will work with each of the 10 intervention sites to develop site-specific, adapted care pathways that consider relevant work flows, institutional culture and available resources.

Group II: ControlActive Control1 Intervention

At control sites, usual care will be provided, which may or may not include symptom screening, access to CPGs or care pathways. Participants will complete SSPedi to obtain the primary outcome at weeks 0, 4 and 8 but the scores will not be revealed to providers and will not be linked to care pathways.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Hospital for Sick ChildrenLead Sponsor

689 Previous Clinical Trials

6,944,977 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,662 Previous Clinical Trials

40,925,629 Total Patients Enrolled

Lillian Sung, MD, PhDPrincipal InvestigatorThe Hospital for Sick Children

4 Previous Clinical Trials

761 Total Patients Enrolled

Media Library

SPARK Symptom Screening Linked to Feedback to Providers Clinical Trial Eligibility Overview. Trial Name: NCT04614662 — Phase 3

Pediatric Cancer Research Study Groups: Intervention, Control

Pediatric Cancer Clinical Trial 2023: SPARK Symptom Screening Linked to Feedback to Providers Highlights & Side Effects. Trial Name: NCT04614662 — Phase 3

SPARK Symptom Screening Linked to Feedback to Providers 2023 Treatment Timeline for Medical Study. Trial Name: NCT04614662 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there vacancies in this study for new participants?

"From the data available on clinicaltrials.gov, it can be inferred that this clinical trial is still recruiting patients. The trial was originally posted on 8/2/2021 and was updated as recently as 6/15/2022."

Answered by AI

Could you give us an estimate of how many research subjects are involved in this project?

"In order to carry out this trial, 444 individuals who fit the bill are needed. These potential participants can be found at various medical facilities, like Roswell Park Comprehensive Cancer Center in Buffalo, New york or Driscoll Children's Hospital in Corpus Christi, Texas."

Answered by AI

At how many different research facilities is this study being conducted?

"To make things more convenient for patients, this clinical trial has 20 sites enrolling patients. If you choose to participate, pick a site near you from the list below. BuffaloCorpus ChristiHouston20 other locations"

Answered by AI

Does the SPARK Symptom Screening Linked to Feedback to Providers have any potential risks?

"SPARK Symptom Screening Linked to Feedback to Providers has Phase 3 clinical trial data supporting both efficacy and safety, so it received a score of 3."

Answered by AI