Symptom Screening with Provider Feedback for Pediatric Cancer

Recruiting in Palo Alto (17 mi)

+20 other locations

Overseen byLillian Sung, MD, PhD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: The Hospital for Sick Children

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?Most children with cancer survive because they are given intensive treatments, but unfortunately, these treatments are associated with distressing symptoms. To address this problem, we developed the Symptom Screening in Pediatrics Tool (SSPedi) so that children receiving cancer treatments can communicate their bothersome symptoms, and Supportive care Prioritization, Assessment and Recommendations for Kids (SPARK), a web-based application that links identified symptoms to supportive care guidelines for symptom management. To establish that these tools improve the lives of children newly diagnosed with cancer, we will conduct a trial that randomizes 20 pediatric cancer institutions and measures the impact of three times weekly symptom screening, symptom feedback to healthcare providers and the development of care pathways for symptom management to improve total symptom burden, fatigue and quality of life.

Eligibility Criteria

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.

Inclusion Criteria

I have been recently diagnosed with cancer.

Enroll within 28 days after treatment initiation

I speak English or Spanish.

+2 more

Exclusion Criteria

Cognitive disability (attending minimum second grade or equivalent)

I cannot see clearly even with glasses or contacts.

Participant Groups

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.

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.