The PediQUEST Study: Evaluation of Pediatric Quality of Life and Evaluation of Symptoms Technology

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Joanne Wolfe, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01838564
First received: April 19, 2013
Last updated: April 26, 2013
Last verified: April 2013
  Purpose

Over 50% of children dying from cancer still suffer from symptoms that could be effectively alleviated. The purpose of the Pediatric Quality of Life and Evaluation of Symptoms Technology (PediQUEST) Study was to evaluate whether providing feedback to families and providers about how the child is feeling improved child distress and quality of life (QoL) in children with advanced cancer.

PediQUEST is a computerized survey that asks the child and/or parents how the child has been feeling, i.e. whether the child had any physical or emotional symptoms, as well as how other aspects of life, such as school and friends, are going. After the survey is complete a report that summarizes patient/parent answers is printed. When a child reports moderate to high distress from any symptom an email is automatically sent to the primary providers (oncologist, nurse, and psycho-social clinician as well as the pain and palliative care services) alerting them about the child's distress.

In this study we evaluated whether using PediQUEST and providing printed reports to parents and providers reduced distress and improved quality of life in children with advanced cancer. In addition, we wanted to understand whether it was feasible to carry out a randomized controlled trial in children with advanced cancer. Finally, the data collected, will be used to describe the natural history of symptoms and quality of life as reported by the children.

Children enrolled in the study (or their parents) were asked to complete a PediQUEST survey at most once a week. A random half of the children received the feedback intervention, i.e. patients, parents, and providers received printed reports (and emails if the child was in distress). The other half only completed the PediQUEST surveys and did not receive reports. We analyzed data collected over 20 weeks of follow-up to see whether receiving PediQUEST reports had any effect on child distress and quality of life.


Condition Intervention
Pediatric Neoplasm
Quality of Life
Outcome Assessment
Palliative Care
Other: Routine Data collection
Other: Feedback of patient-reported outcomes

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: The PediQUEST Study: Evaluation of Pediatric Quality of Life and Evaluation of Symptoms Technology

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Child Distress - unrelieved symptoms [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
    Child distress-unrelieved symptoms will be assessed through the proportion of patients with unrelieved symptoms (any symptom/s reported as causing moderate to high distress or FPS-R score >=8 in 2 consecutive PediQUEST evaluations)

  • Trends of PedsQL Total Scores [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
    Trends of PedsQL total scores over time. PedsQL is a continuous variable (Range: 0-100. 100 highest quality of life).

  • Trends of MSAS total scores [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
    Trends of MSAS total score over time(MSAS total score is a continuous variable; range: 0-100. 100 worst).

  • Trends of MSAS physical scores [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
    Trends over time of MSAS physical subscale scores (MSAS physical subscale score is a continuous variable. Range: 0-100. 100 highly symptomatic.)

  • Trends of MSAS psychological scores [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
    Trends over time of MSAS psychological subscale scores (MSAS psychological subscale scores is a continuous variable. Range: 0-100. 100 highly symptomatic.)

  • Trends of PedsQL Physical Subscale Scores [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
    Trends of PedsQL physical subscale scores over time. PedsQL physical score is a continuous variable (Range: 0-100. 100 highest quality of life).

  • Trends of PedsQL Emotional Subscale Scores [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
    Trends of PedsQL emotional subscale scores over time. PedsQL emotional score is a continuous variable (Range: 0-100. 100 highest quality of life).


Secondary Outcome Measures:
  • Parental distress over time [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
    Trends in Kessler-6 scores (general psychological distress scale) over 20 weeks. Continuous variable. Range:0-24 (24 is high distress).

  • Patterns of care - Referrals to support services [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
    N° of referrals to support services (Psychiatry service, Pastoral Care): continuous variable.

  • Patterns of care - Chemotherapy during last month of life [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
    Proportion of patients receiving chemotherapy during the last month of life

  • Patterns of care - Use of hospice/home care [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
    Proportion of patients receiving home care assistance or hospice care

  • Patterns of care - Time of documentation of prognosis discussions [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
    Time of documentation (N° of days before death) of discussions about prognosis

  • Patterns of care - Time of documentation of resuscitation status [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
    Time of documentation (N° of days before death) of discussions about resuscitation status

  • Patterns of care - Ventilatory assistance in last day of life [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
    Proportion of patients who were intubated in the last 24 hrs of life.

  • Patterns of care - Hospital deaths [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
    Proportion of patients who died at the hospital


Other Outcome Measures:
  • Satisfaction with PediQUEST [ Time Frame: At 4th PediQUEST administration ] [ Designated as safety issue: No ]

    Satisfaction with the technology and with the feedback system will be assessed twice at the fourth and eight PediQUEST administration. Specifically we will assess consumers'impressions about the technology, easiness of use, relevance.

    Among those receiving the feedback intervention we also assessed whether reports helped parents understand their children's feelings better, facilitated communication with doctors and overall satisfaction with the technology and feedback.

    Finally, we also assessed providers satisfaction with feedback reports including their impression about the reports and whether reports affected their behaviors regarding symptom management.



Enrollment: 104
Study Start Date: November 2004
Study Completion Date: June 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Routine data collection
Routine collection of patient-reported symptom and Quality of life data using PediQUEST surveys
Other: Routine Data collection

Patients assigned to the control arm answered PediQUEST (PQ) surveys at most once a week and at least once a month. PQ-surveys were administered through a tablet computer if patient was at the clinic or ward or over the phone if patient was primarily at home. PQ-survey had 9 age- and respondent- adapted versions.

Control arm participants reported their satisfaction with the PediQUEST technology twice 4th and 8th PediQUEST administration. These surveys were embedded in PediQUEST.

Other Name: Control arm
Experimental: Feedback of patient-reported outcomes
Routine collection of QOL and symptom data + feedback
Other: Routine Data collection

Patients assigned to the control arm answered PediQUEST (PQ) surveys at most once a week and at least once a month. PQ-surveys were administered through a tablet computer if patient was at the clinic or ward or over the phone if patient was primarily at home. PQ-survey had 9 age- and respondent- adapted versions.

Control arm participants reported their satisfaction with the PediQUEST technology twice 4th and 8th PediQUEST administration. These surveys were embedded in PediQUEST.

Other Name: Control arm
Other: Feedback of patient-reported outcomes
Patients, parents and primary providers received printed reports summarizing patient/parent reported outcomes for last five visits. When child reported moderate-severe distress an email was automatically sent to primary providers (oncologist, nurses and psychosocial clinicians), as well as to the pain and palliative care services.
Other Names:
  • Feedback
  • Intervention arm

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   2 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children >=2-years old with at least a 2-week history of progressive, recurrent, or non-responsive cancer of any type or decision not to pursue cancer directed therapy.
  • Child's parent must have spoken and written command of English or Spanish.
  • Child's parent must have the ability to understand and complete self-administered surveys.

Exclusion Criteria:

  • Patients who have an isolated relapsed solid tumor treated with surgery or radiation alone.
  • Patients with hematological malignancies who have achieved remission after the first induction attempt, whose treatment plan includes their first Stem Cell Transplant (SCT), and have an identified donor (must meet all 3 criteria to be excluded).
  • Patients who are not regular patients at one of the two participating institutions.
  • Foster parents who do not have legal guardianship.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01838564

Locations
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
United States, Pennsylvania
Children's Hospital of Philapdelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Principal Investigator: Joanne Wolfe, MD Dana-Farber Cancer Institute
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Joanne Wolfe, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01838564     History of Changes
Other Study ID Numbers: 04-321, 1K07CA096746-01
Study First Received: April 19, 2013
Last Updated: April 26, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Dana-Farber Cancer Institute:
Pediatric Advanced Cancer
Children
Quality of Life
Health Information technology
Patient reported outcomes

ClinicalTrials.gov processed this record on September 22, 2014