The PediQUEST Response Intervention Study

November 26, 2024 updated by: Joanne Wolfe, MD, MPH

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Background: Integration of palliative care (PC) has been associated with better health related quality of life (HRQoL) and longer survival in adults and their caregivers. Yet, only a few randomized controlled trials (RCTs) have evaluated whether PC integration improves child and family outcomes. The investigators propose to evaluate the effects of an early PC intervention (PediQUEST Response) for pediatric oncology patients (from here on called patients) with advanced cancer on patient and parent outcomes.

Aims:

  • Aim 1 To evaluate whether PediQUEST Response, compared to usual care, improves patient's HRQoL (primary outcome) and symptom burden.
  • Aim 2 To evaluate the impact of the intervention on parent psychological distress and symptom-related stress outcomes.
  • Aim 3 To compare family activation by measuring coping strategies between study entry and 16 weeks, use of non-pharmacologic strategies for symptom treatment, and No. of documented psychosocial clinician encounters between intervention and control arms.

Design: Multisite, randomized (1:1), controlled, un-blinded, effectiveness trial comparing PediQUEST Response (intervention) vs usual cancer care (comparator).

Setting: Dana-Farber/Boston Children's Cancer and Blood Disorders Center (DFBCC), Seattle Children's Hospital, Children's Hospital of Philadelphia Cancer Center, and St. Jude's Research Hospital.

Participants: The target sample size (SS) is 136 patient-parent dyads (N=68/arm, 34/site) ≥2 years old receiving cancer care at the participating sites and with advanced cancer who have not been referred to the palliative care team. To achieve this SS, 200 dyads will be recruited.

Interventions:

  • PediQUEST Response: consists of combining a patient-mediated activation intervention (weekly feedback of patient-reported outcomes to families and providers using the online PediQUEST web system or mobile App) with early integration of the PC team (consisting of an initial meeting with providers and family with subsequent follow-up including a monthly encounter or as needed number of encounters based on PediQUEST reports and other clinical indications). PC teams will receive standardized training before starting the intervention to learn how to interpret and react to PediQUEST reports and to encourage them to build a close relationship with the patient's primary oncology team. Response teams will also receive ongoing support throughout the intervention period through their local PIs and an expert listserv.
  • Usual Cancer Care (comparator): participants in this arm will receive usual cancer care provided at the sites, which can include PC consultation as deemed necessary by oncologist, and will use the PediQUEST web system to complete surveys but no reports will be generated.

Methods: Following enrollment, patient (if older than 5 years) and parents of all enrolled patients will receive weekly PediQUEST-Surveys including a patient HRQoL measure (PedsQL) and a symptom burden scale (PediQUEST-MSAS). Parents will complete a Baseline Survey Packet (will collect socio-demographic information, trait-anxiety, social support, stress, and coping style). A two-week run-in period will identify and exclude non-responder dyads (i.e. <2 answered PediQUEST-Surveys out of 3 assigned). Responders will be randomized to the intervention or control arms (concealed allocation) and followed up for 16-weeks (16-w). Those assigned to the intervention will begin receiving PediQUEST Response (feedback reports + response team intervention). Parents in both arms will be assigned monthly questionnaires (measuring parental distress, HRQoL, and use of complementary therapies; on weeks 8 and 16 symptom-related stress and coping will also be measured). All surveys will be administered through PediQUEST web. Process measures will be collected throughout the study, and semi-structured exit interviews conducted in participating patients, parents, and a sub-sample of providers. Participants in the intervention arm will be offered continued care by the PC team once the intervention ceases.

Outcomes: Average difference between the two treatment arms in: (i) Patient outcomes: primary study outcome is the mean child's quality of life total score as reported by parent and patient over 16 weeks; we will also look at quality of life subscale scores, mean patient symptom burden scores, parent distress (anxiety, depression and symptom related stress), and family activation (coping, and "symptom treatment activation"). See details below in outcomes section.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
196

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Ann & Robert H. Lurie Children's Hospital of Chicago
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute
      • Boston, Massachusetts, United States, 02215
        • Boston Children's Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104-4318
        • The Children's Hospital of Philadelphia
    • Texas
      • Houston, Texas, United States, 77030
        • Texas Children's Hospital
    • Washington
      • Seattle, Washington, United States, 98145-5005
        • Seattle Children's Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: 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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
16 weeks (measured weekly from point of randomization)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
16 weeks (measured weekly from point of randomization)
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.
16 weeks (measured weekly from point of randomization)
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.
16 weeks (measured weekly from point of randomization)
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.
16 weeks (measured every four weeks from point of randomization)
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).
16 weeks (measured every four weeks from point of randomization)
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.
16 weeks (measured at study entry and 16 weeks)
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.
16 weeks (measured at study entry and 16 weeks)
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)
16 weeks (measured every four weeks from point of randomization)
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.
16 weeks (measured every four weeks from point of randomization)
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.
16 weeks (measured every four weeks from point of randomization)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Joanne Wolfe, MD, MPH

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Baylor College of Medicine
Children's Hospital of Philadelphia
National Institute of Nursing Research (NINR)
Dana-Farber Cancer Institute
University of Alabama at Birmingham
Boston Children's Hospital
Seattle Children's Hospital
St. Jude Children's Research Hospital
Ann & Robert H Lurie Children's Hospital of Chicago
Nationwide Children's Hospital
Children's Hospitals and Clinics of Minnesota
Deakin University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Joanne Wolfe, MD, Dana-Farber Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 14, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 14, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 17, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 24, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 17-102
  • R01NR016720-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing 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.

IPD Sharing Access Criteria

See plan description. No url available yet.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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