A multisite randomized controlled trial of an early palliative care intervention in children with advanced cancer: The PediQUEST Response Study Protocol

A multisite randomized controlled trial of an early palliative care intervention in children with advanced cancer: The PediQUEST Response Study Protocol

Dussel V; Orellana L; Holder R; Porth R; Avery M; Wolfe J

PLOS ONE

2022

Background The Pediatric Quality of Life and Evaluation of Symptoms Technology Response to Pediatric Oncology Symptom Experience (PQ-Response) intervention aims to integrate specialized pediatric palliative care into the routine care of children, adolescents, and young adults (AYAs) with advanced cancer. Aims To evaluate whether PQ-Response, compared to usual care, improves patient’s health related quality of life (HRQoL) and symptom burden (aim 1), parent psychological distress and symptom-related stress (aim 2), and family and symptom treatment activation (aim 3). Design Multisite, randomized (1:1), controlled, un-blinded, effectiveness trial comparing PediQUEST Response (intervention) vs usual cancer care (control). Setting Five US large, tertiary level pediatric cancer centers. Participants Children (≥2 years old)/AYAs who receive care at any of the participating sites because of advanced cancer or any progressive/recurrent solid or brain tumor and are palliative care “naïve.” Target: 200 enrolled patient-parent dyads (minimum goal: 136 dyads randomized, N = 68/arm). Interventions PediQUEST Response: combines patient-mediated activation (weekly feedback of patient- and parent-reported symptoms and HRQoL to families and providers using the PediQUEST web system) with integration of the palliative care team. Usual Cancer Care: participants receive usual care, which can include palliative care consultation, and use PediQUEST web to answer surveys, with no feedback. Methods Following enrollment, patients (if ≥5 years) and one parent receive weekly PediQUEST-Surveys assessing HRQoL (Pediatric Quality of Life Inventory 4.0) and symptom burden (PediQUEST-Memorial Symptom Assessment Scale). After a 2-week run-in period, dyads who answer ≥2 PediQUEST surveys per participant (responders), are randomized (concealed allocation) and followed up for 16-weeks. Parents answer six additional surveys (parent outcomes). Outcomes Primary: mean patient HRQoL score over 16-weeks as reported by a) the parent; and b) the patient if ≥5 years-old. Secondary: patient’s symptom burden; parent’s anxiety, depressive symptoms, symptom-related stress; family activation; and symptom treatment activation. Trial registration ClinicalTrials.gov (NCT03408314) 1/24/18. https://clinicaltrials.gov/ct2/show/NCT03408314.

Article information provided for research and reference use only. PedPalASCNET does not hold any rights over the resource listed here. All rights are retained by the journal listed under publisher and/or the creator(s).

2022 Special Edition 3 - Oncology List