Symptom Screening Linked to Care Pathways
3 other identifiers
interventional
445
2 countries
21
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2021
Typical duration for not_applicable
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 21, 2020
CompletedFirst Posted
Study publicly available on registry
November 4, 2020
CompletedStudy Start
First participant enrolled
August 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 18, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 25, 2023
CompletedResults Posted
Study results publicly available
September 23, 2025
CompletedSeptember 23, 2025
September 1, 2025
2.2 years
October 21, 2020
March 14, 2025
September 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Symptom Screening in Pediatrics Tool (SSPedi) Total Score
SSPedi measures the degree to which 15 symptoms bothered the participant yesterday or today. Each symptom is scored on a 5-point Likert scale ranging from 0 (not at all bothered) to 4 (extremely bothered). The total score ranges from 0 to 60 where higher numbers indicate more bothersome symptoms. The total SSPedi score is reliable, valid and responsive to change in children with cancer 8-18 years of age.(1)
Week 8
Secondary Outcomes (5)
Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Bank v2.0 - Fatigue
Week 8
PedsQL 3.0 Acute Cancer Module
Week 8
Documentation of Symptoms
Week 8
Provision of Interventions for Symptoms (Independent of Symptom Documentation)
Week 8
Number of Emergency Department Visits and Unplanned Clinic Visits and Hospitalizations
8 weeks
Study Arms (2)
Intervention
EXPERIMENTALParticipants 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.
Control
NO INTERVENTIONAt 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.
Interventions
Symptom screening three times weekly via SPARK, feedback of symptoms to healthcare providers and development of care pathways for symptom management.
Eligibility Criteria
You may qualify if:
- years of age at enrollment
- English or Spanish-speaking
- Any newly diagnosed cancer
- Have a plan for any chemotherapy, radiotherapy or surgery
- Enroll within 28 days after treatment initiation
You may not qualify if:
- Cognitive disability (attending minimum second grade or equivalent)
- Visual impairment (cannot see SPARK even with corrective lens)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Hospital for Sick Childrenlead
- National Cancer Institute (NCI)collaborator
Study Sites (21)
Phoenix Children's Hospital
Phoenix, Arizona, 85016-7710, United States
Children's Hospital Los Angeles
Los Angeles, California, 90027-6062, United States
The Leland Stanford Junior University
Redwood City, California, 94305-2004, United States
University of Colorado Denver
Aurora, Colorado, 80045-2571, United States
Connecticut Children's Medical Center
Hartford, Connecticut, 06106, United States
Nemours Children's Hospital, Delaware
Wilmington, Delaware, 19803, United States
Nemours Children's Health, Jacksonville
Jacksonville, Florida, 32207, United States
Nemours Children's Hospital, Florida
Orlando, Florida, 32827, United States
Kapi'olani Medical Center for Women & Children
Honolulu, Hawaii, 96826, United States
Unity Point Health - Blank Children's Hospital
Des Moines, Iowa, 50309, United States
The University of Iowa
Iowa City, Iowa, 52242, United States
Children's Hospital
New Orleans, Louisiana, 70118, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14203, United States
The Trustees of Columbia University in the City of New York
New York, New York, 10032, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37203-1161, United States
Driscoll Children's Hospital
Corpus Christi, Texas, 78411, United States
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030, United States
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229-3901, United States
Virginia Commonwealth University
Richmond, Virginia, 23298-0568, United States
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
Related Publications (7)
Dupuis LL, Johnston DL, Baggott C, Hyslop S, Tomlinson D, Gibson P, Orsey A, Dix D, Price V, Vanan M, Portwine C, Kuczynski S, Spiegler B, Tomlinson GA, Sung L. Validation of the Symptom Screening in Pediatrics Tool in Children Receiving Cancer Treatments. J Natl Cancer Inst. 2018 Jun 1;110(6):661-668. doi: 10.1093/jnci/djx250.
PMID: 29272441BACKGROUNDHinds PS, Nuss SL, Ruccione KS, Withycombe JS, Jacobs S, DeLuca H, Faulkner C, Liu Y, Cheng YI, Gross HE, Wang J, DeWalt DA. PROMIS pediatric measures in pediatric oncology: valid and clinically feasible indicators of patient-reported outcomes. Pediatr Blood Cancer. 2013 Mar;60(3):402-8. doi: 10.1002/pbc.24233. Epub 2012 Jul 24.
PMID: 22829446BACKGROUNDVarni JW, Burwinkle TM, Katz ER, Meeske K, Dickinson P. The PedsQL in pediatric cancer: reliability and validity of the Pediatric Quality of Life Inventory Generic Core Scales, Multidimensional Fatigue Scale, and Cancer Module. Cancer. 2002 Apr 1;94(7):2090-106. doi: 10.1002/cncr.10428.
PMID: 11932914BACKGROUNDDupuis LL, Vettese E, Aftandilian C, Agarwal V, Baggott C, Bradfield SM, Crellin-Parsons N, Freyer DR, Kelly KM, King AA, Kyono W, Nagasubramanian R, Orgel E, Roth ME, Sherani F, Yu L, Grimes AC, Beauchemin MP, Klesges LM, Tomlinson GA, Sung L. Factors Associated With Self-Report Symptom Screening Adherence in Pediatric Cancer Patients. Cancer Med. 2025 Jul;14(14):e71053. doi: 10.1002/cam4.71053.
PMID: 40686265DERIVEDDupuis LL, Vettese E, Grimes AC, Beauchemin MP, Klesges LM, Baggott C, Demedis J, Aftandilian C, Freyer DR, Crellin-Parsons N, Orgel E, Dickens D, Kelly KM, Kyono W, Walsh A, Sherani F, Cannone D, Orsey AD, King AA, Yu L, Woods-Swafford W, Bradfield SM, Roth ME, Esbenshade AJ, Caywood EH, Agarwal V, Nagasubramanian R, Tomlinson GA, Sung L. Symptom Screening Linked to Care Pathways for Pediatric Patients With Cancer: A Randomized Clinical Trial. JAMA. 2024 Dec 17;332(23):1981-1991. doi: 10.1001/jama.2024.19585.
PMID: 39535768DERIVEDVettese E, Sherani F, King AA, Yu L, Aftandilian C, Baggott C, Agarwal V, Nagasubramanian R, Kelly KM, Freyer DR, Orgel E, Bradfield SM, Kyono W, Roth M, Klesges LM, Beauchemin M, Grimes A, Tomlinson G, Dupuis LL, Sung L. Symptom management care pathway adaptation process and specific adaptation decisions. BMC Cancer. 2023 Apr 17;23(1):350. doi: 10.1186/s12885-023-10835-0.
PMID: 37069510DERIVEDDupuis LL, Grimes A, Vettese E, Klesges LM, Sung L. Readiness to Implement Symptom Management Care Pathways in Pediatric Cancer. Res Sq [Preprint]. 2020 Dec 30:rs.3.rs-136225. doi: 10.21203/rs.3.rs-136225/v1.
PMID: 33398260DERIVED
MeSH Terms
Conditions
Results Point of Contact
- Title
- Lillian Sung
- Organization
- The Hospital for Sick Children
Study Officials
- PRINCIPAL INVESTIGATOR
Lillian Sung, MD, PhD
The Hospital for Sick Children
- PRINCIPAL INVESTIGATOR
Laura Lee Dupuis, RPh, PhD
The Hospital for Sick Children
- PRINCIPAL INVESTIGATOR
Allison Grimes, MD
The University of Texas Health Science Center at San Antonio
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Pediatric Oncologist
Study Record Dates
First Submitted
October 21, 2020
First Posted
November 4, 2020
Study Start
August 2, 2021
Primary Completion
October 18, 2023
Study Completion
October 25, 2023
Last Updated
September 23, 2025
Results First Posted
September 23, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Five years
- Access Criteria
- Upon request to, and approval by the study team
The full data set including the patient-reported outcome data will be available publically following trial completion after ensuring that no patient can be identified and no disclosure of personal health information. The data will become available no later than one year after the primary publication and will be available for at least five years.