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COMPLETED NA

The PediQUEST Response Intervention Study

NCT03408314 · View on ClinicalTrials.gov ↗

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 Studied

Interventions

  • OTHER PediQUEST Response
  • OTHER Usual Cancer Care

Study Locations (6)

Massachusetts

  • Boston Children's Hospital — Boston
  • Dana Farber Cancer Institute — Boston

Illinois

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

Pennsylvania

  • The Children's Hospital of Philadelphia — Philadelphia

Texas

  • Texas Children's Hospital — Houston

Washington

  • Seattle Children's Research Institute — Seattle

Trial Details

FieldValue
Enrollment Target 196 participants
Start Date 2018-03-01
Est. Completion 2022-09-14
Phase NA

Sponsor

Joanne Wolfe, MD, MPH

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03408314

The ClinicalTrials.gov registry entry for NCT03408314 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 196 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Joanne Wolfe, MD, MPH, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Advanced Cancer appearing as the primary indexed condition, and to 2 interventions — of which PediQUEST Response is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03408314 reports 6 study locations spanning 5 distinct geographic areas — top geographies include Massachusetts, Illinois, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03408314 about?

NCT03408314 is a clinical study titled "The PediQUEST Response Intervention Study". 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 r...

What is the current status of trial NCT03408314?

This trial is currently completed. It is a NA study. The enrollment target is 196 participants. The study started on 2018-03-01. Estimated completion is 2022-09-14.

What conditions does trial NCT03408314 study?

This clinical trial studies the following conditions: Advanced Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03408314?

The interventions under investigation include: PediQUEST Response (OTHER), Usual Cancer Care (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03408314?

This trial is sponsored by Joanne Wolfe, MD, MPH, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03408314 being conducted?

This trial has 6 study locations across Illinois, Massachusetts, Pennsylvania, Texas, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial