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NCT03408314 · ClinicalTrials.gov registry record · NA
The PediQUEST Response Intervention Study
A NA study of Advanced Cancer, sponsored by Joanne Wolfe, MD, MPH.
- Completed
- Registry status
- NA
- Development phase
- 196
- Enrollment target
- 6
- Study locations
NCT03408314 is a NA study of Advanced Cancer that has completed, run by Joanne Wolfe, MD, MPH. The registered enrollment target is 196 participants, below the 245-participant average among 122 other Advanced Cancer trials with a reported enrollment target (20% lower). The trial reports 6 study locations across 5 states.
The verdict
NCT03408314, a NA study of Advanced Cancer, has completed, sponsored by Joanne Wolfe, MD, MPH.
- COMPLETED
- Registry status
- NA
- Development phase
- 196 participants
- Enrollment target
- 6
- Study locations
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
| Field | Value |
|---|---|
| Enrollment Target | 196 participants |
| Start Date | 2018-03-01 |
| Est. Completion | 2022-09-14 |
| Phase | NA |
Interested in This Trial?
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, categorized as NA. The registered enrollment target is 196 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 245-participant average among 122 other Advanced Cancer trials with a reported enrollment target (20% lower). The listed sponsor is Joanne Wolfe, MD, MPH, which has 1 total studies on file at ClinicalTrials.gov.
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.
NCT03408314 reports 6 study locations spanning 5 distinct geographic areas - top geographies include Massachusetts, Illinois, Pennsylvania.
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.
What interventions are being tested in trial NCT03408314?
The interventions under investigation include: PediQUEST Response (OTHER), Usual Cancer Care (OTHER).
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.
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.
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Related
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