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The PediQUEST Response Intervention Study

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ClinicalTrials.gov Identifier: NCT03408314
Recruitment Status : Recruiting
First Posted : January 24, 2018
Last Update Posted : August 2, 2018
Sponsor:
Collaborators:
Children's Hospital of Philadelphia
Seattle Children's Hospital
St. Jude Children's Research Hospital
Children's Hospitals and Clinics of Minnesota
Nationwide Children's Hospital
University of Alabama at Birmingham
Deakin University
Boston Children’s Hospital
Ann & Robert H Lurie Children's Hospital of Chicago
Information provided by (Responsible Party):
Joanne Wolfe, MD, Dana-Farber Cancer Institute

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.


Condition or disease Intervention/treatment Phase
Advanced Cancer Other: PediQUEST Response Other: Usual Cancer Care Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: 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
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

Arm Intervention/treatment
Experimental: PediQUEST Response
  • 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)
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.

Usual Cancer Care
  • 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)
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).




Primary Outcome Measures :
  1. Child Quality of Life [ Time Frame: 16 weeks (measured weekly from point of randomization) ]
    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.


Secondary Outcome Measures :
  1. Child Quality of Life - subscales [ Time Frame: 16 weeks (measured weekly from point of randomization) ]
    Difference between intervention and control arms of the mean Pediatric Quality of Life Inventory 4.0 (PedsQL) subscale scores (physical and psychosocial) 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 subscale scores that will be utilized in the study are the physical subscale (average of the 8 physcial items) and the psychosocial subscale (average of the 15 remaining items, which cover the domains of emotion, social and school). Subscale scores range from 0-100 (100 is excellent quality of life)

  2. Child Symptom Burden [ Time Frame: 16 weeks (measured weekly from point of randomization) ]
    Difference between intervention and control arms of the mean PediQUEST-Memorial Symptom Assessment Scale (PQ-MSAS) total scores over 16 weeks, as reported by (a) the parent for all enrolled children and (b) the patient, if 13 years of age or older. PediQUEST MSAS total scores are calculated as the average of the 26 individual symptom scores that are included in the teens and caregivers versions of the tool. Individual symptom scores are calculated as the average of the three symtpom questions. Individual symptom scores and total scores range from 0-100, 100 indicates higher symptom burden.

  3. Child Symptom Burden- subscales [ Time Frame: 16 weeks (measured weekly from point of randomization) ]
    Difference between intervention and control arms of the mean PediQUEST-Memorial Symptom Assessment Scale (PQ-MSAS) subscale scores over 16 weeks, as reported by (a) the parent for all enrolled children and (b) the patient, if 13 years of age or older. PediQUEST MSAS subscale scores that will be used in this study include the PediQUEST-MSAS physical (average of 8 prevalent physical symptoms) and PediQUEST-MSAS psychological (average of 6 psychological items). Subscale scores range from 0-100, 100 indicates higher symptom burden.

  4. Parental distress (anxiety) [ Time Frame: 16 weeks (measured every four weeks from point of randomization) ]
    Difference between trial arms of the mean Spielberger's-State Anxiety Inventory scores over 16 weeks. Scores range from 20 to 80, with higher scores correlating with greater anxiety.

  5. Parental distress (depression) [ Time Frame: 16 weeks (measured every four weeks from point of randomization) ]
    Difference between trial arms of the mean Center for Epidemiologic Studies Short Depression Scale scores over 16 weeks. Scores range from 0 to 30 (Score of 10 or higher indicates the presence of significant depressive symptoms).

  6. Parental distress (stress) [ Time Frame: 16 weeks (measured at study entry and 16 weeks) ]
    Difference between trial arms of the change in symptom-related stress scores measured with an adapted version of the stress-portion of the Response to Stress Questionnaire-Pain at study entry and the 16-week point. The tool assesses 12 potential stress sources. Scores range from 1-4 (higher means more stress). Symptom-related stress score calculated as the sum of the 12 item scores.

  7. Family Activation (coping) [ Time Frame: 16 weeks (measured at study entry and 16 weeks) ]
    Change in BRIEF-Cope active coping, planning, and instrumental support scale scores between study entry and 16 weeks between intervention and control arms. Each item is scored 1-4 (higher means using that strategy a lot). Each scale score is calculated as the average of the two items that measure the strategy.

  8. Family Activation (symptom treatment activation - use of complementary therapies (UCT) - number) [ Time Frame: 16 weeks (measured every four weeks from point of randomization) ]
    Difference between intervention and control arms in "symptom treatment activation" over 16 weeks, measured every four weeks as the total No. of complementary therapies (CT), as reported by parents.(this outcome is a count, not a score)

  9. Family Activation (symptom treatment activation - UCT - types) [ Time Frame: 16 weeks (measured every four weeks from point of randomization) ]
    Difference between intervention and control arms in "symptom treatment activation" over 16 weeks, measured every four weeks as the No. of different CT, as reported by parents.

  10. Family Activation (symptom treatment activation - use of psychosocial services) [ Time Frame: 16 weeks (measured every four weeks from point of randomization) ]
    Difference between intervention and control arms in "symptom treatment activation" over 16 weeks, measured every four weeks as the No. of psychosocial clinician encounters documented in the medical record.



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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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, and are
  • (ii) palliative care naive.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03408314


Contacts
Contact: Joanne Wolfe, MD, MPH 617-632-5286 Joanne_Wolfe@dfci.harvard.edu
Contact: Veronica Dussel, MD, MPH 6175534136 veronica_dussel@dfci.harvard.edu

Locations
United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02215
Contact: Christina Ulrich, MD    617-632-4997    christina_ullrich@dfci.harvard.edu   
Principal Investigator: Christina Ulrich, MD         
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Joanne Wolfe, MD    617-632-5286    Joanne_Wolfe@dfci.harvard.edu   
Principal Investigator: Joanne Wolfe, MD         
United States, Pennsylvania
The Children's Hospital of Philadelphia Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104-4318
Contact: Chris Feudtner    267-426-5245    FEUDTNER@email.chop.edu   
Contact: Jason Freedman    267-426-5032    freedman@email.chop.edu   
Principal Investigator: Chris Feudtner, MD,MPH,PhD         
Sub-Investigator: Jason Freedman, MD         
United States, Washington
Seattle Children's Research Institute Not yet recruiting
Seattle, Washington, United States, 98145-5005
Contact: Abby Rosenberg    206-987-2106    abby.rosenberg@SeattleChildrens.org   
Contact: Ross Hays    206-987-2176    ross.hays@seattlechildrens.org   
Principal Investigator: Abby Rosenberg, Md, MPH         
Sub-Investigator: Ross Hays, MD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Children's Hospital of Philadelphia
Seattle Children's Hospital
St. Jude Children's Research Hospital
Children's Hospitals and Clinics of Minnesota
Nationwide Children's Hospital
University of Alabama at Birmingham
Deakin University
Boston Children’s Hospital
Ann & Robert H Lurie Children's Hospital of Chicago
Investigators
Principal Investigator: Joanne Wolfe, MD Dana-Farber Cancer Institute

Publications:

Responsible Party: Joanne Wolfe, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT03408314     History of Changes
Other Study ID Numbers: 17-102
First Posted: January 24, 2018    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (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.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Joanne Wolfe, MD, Dana-Farber Cancer Institute:
Advanced Cancer

Additional relevant MeSH terms:
Neoplasms