CompletedNot Applicable

The PediQUEST Response Intervention Study

United States196 participantsStarted 2018-03-01

Plain-language 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.

Who can participate

Age range2 Years

SexALL

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Inclusion criteria: 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. Exclusion criteria: 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.

What they're measuring

Child Quality of Life

Timeframe: 16 weeks (measured weekly from point of randomization)

Trial details

NCT IDNCT03408314

SponsorJoanne Wolfe, MD, MPH

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-09-14