The PediQUEST Response Intervention Study

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.

Conditions

• Advanced Cancer

Interventions

OTHER

PediQUEST Response

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.

OTHER

Usual Cancer Care

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).

Sponsors & Collaborators

• Children's Hospital of Philadelphia

  collaborator OTHER

• Seattle Children's Hospital

  collaborator OTHER

• St. Jude Children's Research Hospital

  collaborator OTHER

• Children's Hospitals and Clinics of Minnesota

  collaborator OTHER

• Nationwide Children's Hospital

  collaborator OTHER

• University of Alabama at Birmingham

  collaborator OTHER

• Deakin University

  collaborator OTHER

• Boston Children's Hospital

  collaborator OTHER

• Ann & Robert H Lurie Children's Hospital of Chicago

  collaborator OTHER

• Baylor College of Medicine

  collaborator OTHER

• Dana-Farber Cancer Institute

  collaborator OTHER

• National Institute of Nursing Research (NINR)

  collaborator NIH

• Joanne Wolfe, MD, MPH

  lead OTHER

Principal Investigators

• Joanne Wolfe, MD · Dana-Farber Cancer Institute

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

2 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-03-01

Primary Completion

2022-09-14

Completion

2022-09-14

Countries

• United States

Study Locations