Related Experiment Video
Updated: Aug 22, 2025
A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
A multisite randomized controlled trial of an early palliative care intervention in children with advanced cancer:
Veronica Dussel1,2, Liliana Orellana3, Rachel Holder4
1Pediatric Palliative Care, Dana-Farber / Boston Children's Cancer and Blood Disorders Center, Boston, MA, United States of America.
Insights
This study evaluated the PQ-Response intervention for pediatric cancer patients, showing potential to improve quality of life and reduce symptom burden. Further research is needed to confirm these findings in advanced cancer care.
Area of Science:
- Oncology
- Palliative Care
- Health Services Research
Background:
- Integrating specialized pediatric palliative care into routine care for advanced cancer patients is crucial.
- The PQ-Response intervention aims to enhance care for children, adolescents, and young adults (AYAs) with advanced cancer.
Purpose of the Study:
- To assess if the PQ-Response intervention improves patient-reported health-related quality of life (HRQoL) and symptom burden compared to usual care.
- To evaluate the intervention's impact on parent psychological distress, symptom-related stress, and family/symptom treatment activation.
Main Methods:
- A multisite, randomized controlled trial comparing PQ-Response to usual cancer care.
- Inclusion criteria: pediatric patients (≥2 years) with advanced cancer, naive to palliative care.
- Outcomes measured over 16 weeks, including patient HRQoL, symptom burden, and parent-reported outcomes.
Main Results:
- The study is registered on ClinicalTrials.gov (NCT03408314).
- Primary outcomes include patient-reported HRQoL and symptom burden.
- Secondary outcomes encompass parent psychological distress and activation levels.
Conclusions:
- The PQ-Response intervention seeks to improve the quality of life and symptom management for pediatric oncology patients.
- This trial will provide valuable data on the effectiveness of integrating palliative care through technology-enhanced feedback loops.
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.
More Related Videos
06:28E-Patient Counseling Trial E-PACO: Computer Based Education versus Nurse Counseling for Patients to Prepare for Colonoscopy
Published on: August 1, 2019
05:22Intracranial Cannula Implantation for Serial Locoregional Chimeric Antigen Receptor CAR T Cell Infusions in Mice
Published on: February 24, 2023
Related Concept Videos
02:56Treatment Resistant Cancers
01:16Clinical Trials
There are four phases in a clinical trial. A phase one...
01:11Clinical Trials: Overview
01:25Continuing Care