Clinical trial · Interventional
Symptom Screening Linked to Care Pathways
Symptom Screening Linked to Care Pathways for Children With Cancer: a Cluster Randomized Trial
NCT04614662CI-TRIAL-00095653completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pediatric Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SPARK Symptom Screening Linked to Feedback to Providers | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention
- description
- 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.
- interventionNames
- Behavioral: SPARK Symptom Screening Linked to Feedback to Providers
- type
- NO_INTERVENTION
- label
- Control
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 8 Years
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 8-18 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 Exclusion Criteria: * Cognitive disability (attending minimum second grade or equivalent) * Visual impairment (cannot see SPARK even with corrective lens)
References
Publications (8)
- BACKGROUNDDupuis 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 29272441
- BACKGROUNDHinds 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 22829446
- BACKGROUNDVarni 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 11932914
- DERIVEDYan AP, Dupuis LL, Aftandilian C, Agarwal V, Baggott C, Beauchemin MP, Bradfield SM, Cannone D, Caywood EH, Crellin-Parsons N, Demedis J, Dickens D, Esbenshade AJ, Freyer DR, Grimes AC, Kelly KM, King AA, Klesges LM, Kyono W, Nagasubramanian R, Orgel E, Orsey AD, Roth ME, Sherani F, Vettese E, Walsh A, Woods-Swafford W, Yu LC, Tomlinson GA, Sung L. Factors Associated With Symptom Burden Among Pediatric Patients With Cancer. JCO Oncol Pract. 2026 Jun;22(6):1087-1095. doi: 10.1200/OP-25-00244. Epub 2025 Aug 14. PMID 40811761
- DERIVEDDupuis 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 40686265
- Dupuis 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.