Clinical trial · Interventional
The PediQUEST Response Intervention Study
A Multisite, Parallel, RCT Comparing the Effectiveness of an Early Palliative Care Intervention, the PediQUEST Response to Pediatric Oncology Symptom Experience , Versus Usual Cancer Care in Children and Adolescents With Advanced Cancer
- 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)
PediQUEST Response proposes a new system of care that expects to improve quality of life in children, adolescents, and young adults with advanced cancer and their parents. The investigators want to learn whether patients that are cared for using PediQUEST Response do in fact feel better than those receiving usual care. National recommendations call for early palliative care (PC) integration for seriously ill children to ease suffering, however, very few randomized controlled trials (RCTs) have evaluated whether PC improves child and family outcomes. In prior work, the investigators developed the Pediatric Quality of Life and Evaluation of Symptoms Technology (PediQUEST/PQ), a software that collects electronic Patient-Reported Outcomes (e-PROMS) and generates feedback reports. Now, the PI and research team developed PediQUEST Response (Response to Pediatric Oncology Symptom Experience). PediQUEST Response includes an enhanced PediQUEST system (web-based and with an App that allows to answer surveys and see reports), that is coupled with early integration of a palliative care consulting team (Response team). This dual strategy will help to standardize the family report of distress, which will be done through the PediQUEST system. It will also help standardize the providers' response to such distress, as providers will be specifically trained. Pilot work for PediQUEST Response found it feasible, well received by families and oncologists, and potentially effective. Thus, the overall goal of this study is to conduct a RCT of PQ Response versus usual care at four large pediatric oncology centers among 136 children ≥2 years old with advanced cancer. Hypotheses include a) children receiving the intervention will have better (higher) quality of life scores b) parents of children in the intervention group will report better state-anxiety, depression and symptom-related stress scores, and c) intervention group families will demonstrate higher levels of activation.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PediQUEST Response | Other | — | UNRESOLVED |
| Usual Cancer Care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PediQUEST Response
- description
- * Weekly PediQUEST surveys are automatically assigned to parents and children (if 5 years old or older) and sent 48 hours prior to participant's usual clinic day * Once a PediQUEST survey is assigned, automated email reminders/app notifications are sent daily for two days * After 48 hours, unanswered or incomplete surveys are auto-submitted * PQ-feedback report generated automatically after a PQ Survey is answered * A pdf of the report is automatically emailed/available on mobile App to designated recipients * Will also receive oncology-PC integrated care through the Response team * Duration of follow-up: 18 weeks (2-week run-in period, followed by a 16-week post-randomization follow-up)
- interventionNames
- Other: PediQUEST Response
- type
- OTHER
- label
- Usual Cancer Care
- description
- * Will receive the usual cancer care provided at the participating sites * Will complete weekly PQ-Surveys (no feedback reports will be generated) * Can receive regular palliative care consultations following the site's usual referral procedures * Same follow-up (18 weeks)
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
Show eligibility criteria text
Inclusion criteria: Pediatric oncology patients (children, adolescents, or young adults), and one of their parents, receiving routine cancer care at one of the participating centers -and not in remission and off cancer-directed treatment-that have: * (i) advanced cancer defined as: at least a 2-week history of progressive, recurrent, or non-responsive cancer of any type, or any brainstem tumor, or a grade IV Glioblastoma Multiforme, or decision not to pursue cancer-directed therapy in place, or or any other progressive/recurrent solid or brain tumor, and are * (ii) palliative care naive, defined as the palliative care team not currently integrated into their regular cancer care. Exclusion criteria: The patient-parent dyad would be excluded if * patients are older than 18 years of age and no parent is involved in his/her care, or * if patient is under the care of foster parents who do not have legal guardianship, or * if both parents do not speak English or Spanish, or are unable to understand and complete surveys, or * if the patient has a non-brainstem low-grade glioma with localized progression/relapse only, or * is expected to receive a stem cell transplant within the next 18 weeks, or * life expectancy is less than two months.
References
Publications (6)
- BACKGROUNDDussel V, Orellana L, Holder R, Porth R, Avery M, Wolfe J. A multisite randomized controlled trial of an early palliative care intervention in children with advanced cancer: The PediQUEST Response Study Protocol. PLoS One. 2022 Nov 8;17(11):e0277212. doi: 10.1371/journal.pone.0277212. eCollection 2022. PMID 36346783
- RESULTFeifer D, Merz AF, Avery M, Tsuchiyose E, Eche-Ugwu IJ, Awofeso O, Wolfe J, Dussel V, Requena ML. Parent Views on Parent and Child-reported Outcomes in Pediatric Advanced Cancer: A Qualitative Study. J Pain Symptom Manage. 2025 Feb;69(2):e131-e138. doi: 10.1016/j.jpainsymman.2024.10.001. Epub 2024 Oct 15. PMID 39414121
- RESULTEche-Ugwu IJ, Orellana L, Becker D, Bona K, Avery M, Feudtner C, Freedman JL, Kang TI, Rosenberg AR, Waldman ED, Ullrich CK, Dussel V, Wolfe J. Household material hardship and distress among parents of children with advanced cancer: A report from the PediQUEST Response trial. Cancer. 2024 Oct 15;130(20):3540-3548. doi: 10.1002/cncr.35432. Epub 2024 Jun 12. PMID 38865435
- RESULTMerz A, Feifer D, Avery M, Tsuchiyose E, Eche I, Awofeso O, Wolfe J, Dussel V, Requena ML. Patient-Reported Outcome Benefits for Children with Advanced Cancer and Parents: A Qualitative Study. J Pain Symptom Manage. 2023 Sep;66(3):e327-e334. doi: 10.1016/j.jpainsymman.2023.05.016. Epub 2023 Jun 6. PMID 37290730
- DERIVEDDussel V, Orellana L, Requena ML, Avery M, Becker D, Ullrich CK, Feudtner C, Freedman JL, Kang TI, Waldman ED, Gerhardt CA, Bakitas MA, Baker JN, Friedrichsdorf SJ, Rosenberg AR, Wolfe J. Integrating Electronic Patient-Reported Outcomes and Palliative Care in Pediatric Advanced Cancer: The PediQUEST Response Multisite Randomized Controlled Trial. J Clin Oncol. 2026 Mar 10;44(8):685-697. doi: 10.1200/JCO-25-01036. Epub 2026 Feb 4. PMID 41637683
- DERIVEDTsuchiyose E, Feifer D, Merz AF, Avery M, Eche-Ugwu IJ, Awofeso O, Orellana L, Becker D, Feudtner C, Freedman JL, Kang TI, Rosenberg AR, Waldman ED, Ullrich CK, Wolfe J, Requena ML, Dussel V. Research Burden in Pediatric Cancer: A Mixed Methods Study From the PediQUEST Response Trial. J Pain Symptom Manage. 2025 Dec;70(6):649-663. doi: 10.1016/j.jpainsymman.2025.08.032. Epub 2025 Sep 1.