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A multisite randomized controlled trial of an early palliative care intervention in children with advanced cancer : the PediQUEST response study protocol
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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.
http://dx.doi.org/10.1371/journal.pone.0277212
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