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
2 other identifiers
interventional
196
1 country
6
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2018
Longer than P75 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2018
CompletedFirst Posted
Study publicly available on registry
January 24, 2018
CompletedStudy Start
First participant enrolled
March 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 14, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 14, 2022
CompletedNovember 29, 2024
November 1, 2024
4.5 years
January 17, 2018
November 26, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Child Quality of Life
Difference between intervention and control arms of the mean Pediatric Quality of Life Inventory 4.0 (PedsQL) total scores over 16 weeks, as reported by (a) the parent for all enrolled children and (b) the patient (if 5 years of age or older). PedsQL total scores are calculated as the average of the 23 items that integrate the tool. Scores range from 0-100 (100 is excellent quality of life). A score of \<70 is considered fair/poor quality of life.
16 weeks (measured weekly from point of randomization)
Secondary Outcomes (10)
Child Quality of Life - subscales
16 weeks (measured weekly from point of randomization)
Child Symptom Burden
16 weeks (measured weekly from point of randomization)
Child Symptom Burden- subscales
16 weeks (measured weekly from point of randomization)
Parental distress (anxiety)
16 weeks (measured every four weeks from point of randomization)
Parental distress (depression)
16 weeks (measured every four weeks from point of randomization)
- +5 more secondary outcomes
Study Arms (2)
PediQUEST Response
EXPERIMENTAL* 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)
Usual Cancer Care
OTHER* 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)
Interventions
PediQUEST Response consists of regular feedback of electronic patient reported outcomes (child symptoms and quality of life) to providers and families coupled with involvement of the palliative care team, who will meet with families and providers within three weeks of randomization and follow-up at least monthly as deemed necessary based on PediQUEST feedback reports and other clinical indications.
Patients assigned to the usual cancer care arm, will receive the standard care provided by participating sites + be required to complete PediQUEST surveys (but no reports will be generated).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Joanne Wolfe, MD, MPHlead
- Children's Hospital of Philadelphiacollaborator
- Seattle Children's Hospitalcollaborator
- St. Jude Children's Research Hospitalcollaborator
- Children's Hospitals and Clinics of Minnesotacollaborator
- Nationwide Children's Hospitalcollaborator
- University of Alabama at Birminghamcollaborator
- Deakin Universitycollaborator
- Boston Children's Hospitalcollaborator
- Ann & Robert H Lurie Children's Hospital of Chicagocollaborator
- Baylor College of Medicinecollaborator
- Dana-Farber Cancer Institutecollaborator
- National Institute of Nursing Research (NINR)collaborator
Study Sites (6)
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Boston Children's Hospital
Boston, Massachusetts, 02215, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104-4318, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
Seattle Children's Research Institute
Seattle, Washington, 98145-5005, United States
Related Publications (5)
Dussel 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: 36346783BACKGROUNDFeifer 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: 39414121RESULTEche-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: 38865435RESULTMerz 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: 37290730RESULTTsuchiyose 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.
PMID: 40902740DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Joanne Wolfe, MD
Dana-Farber Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 17, 2018
First Posted
January 24, 2018
Study Start
March 1, 2018
Primary Completion
September 14, 2022
Study Completion
September 14, 2022
Last Updated
November 29, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
- Time Frame
- After data collection is finalized, we expect to take about 4 to 6 months to compile and submit the main paper. Six months after the main publication has been released, the de-identified database will be available for other ancillary analysis and be kept indefinitely.
- Access Criteria
- See plan description. No url available yet.
The Study Data Center will oversee the data sharing process, with input from the Data and Safety Monitoring Board. Once the database is consolidated, all study investigators that are interested in leading a particular analysis, will be given access to the final password-protected de-identified data sets. Out of study investigators may be allowed access to the datasets after a formal analysis proposal is approved by the steering committee.