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

NCT01838564 | Completed

• 2 other identifiers: 04-3211K07CA096746-01
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Pediatric Neoplasm; Quality of Life; Outcome Assessment; Palliative Care

Keywords

Pediatric Advanced Cancer; Children; Quality of Life; Health Information technology; Patient reported outcomes

Outcome Measures

Primary Outcomes (7)

• Child Distress - unrelieved symptoms

  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)

  20 weeks

• Trends of PedsQL Total Scores

  Trends of PedsQL total scores over time. PedsQL is a continuous variable (Range: 0-100. 100 highest quality of life).

  20 weeks

• Trends of MSAS total scores

  Trends of MSAS total score over time(MSAS total score is a continuous variable; range: 0-100. 100 worst).

  20 weeks

• Trends of MSAS physical scores

  Trends over time of MSAS physical subscale scores (MSAS physical subscale score is a continuous variable. Range: 0-100. 100 highly symptomatic.)

  20 weeks

• Trends of MSAS psychological scores

  Trends over time of MSAS psychological subscale scores (MSAS psychological subscale scores is a continuous variable. Range: 0-100. 100 highly symptomatic.)

  20 weeks

• Trends of PedsQL Physical Subscale Scores

  Trends of PedsQL physical subscale scores over time. PedsQL physical score is a continuous variable (Range: 0-100. 100 highest quality of life).

  20 weeks

• Trends of PedsQL Emotional Subscale Scores

  Trends of PedsQL emotional subscale scores over time. PedsQL emotional score is a continuous variable (Range: 0-100. 100 highest quality of life).

  20 weeks

Secondary Outcomes (8)

• Parental distress over time

  20 weeks

• Patterns of care - Referrals to support services

  20 weeks

• Patterns of care - Chemotherapy during last month of life

  20 weeks

• Patterns of care - Use of hospice/home care

  20 weeks

• Patterns of care - Time of documentation of prognosis discussions

  20 weeks

Other Outcomes (1)

• Satisfaction with PediQUEST

  At 4th PediQUEST administration

Study Arms (2)

Routine data collection

ACTIVE COMPARATOR

Routine collection of patient-reported symptom and Quality of life data using PediQUEST surveys

Other: Routine Data collection

Feedback of patient-reported outcomes

EXPERIMENTAL

Routine collection of QOL and symptom data + feedback

Other: Routine Data collection; Other: Feedback of patient-reported outcomes

Interventions

Routine Data collection OTHER

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.

Also known as: Control arm

Feedback of patient-reported outcomes; Routine data collection

Feedback of patient-reported outcomes OTHER

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.

Also known as: Feedback, Intervention arm

Feedback of patient-reported outcomes

Eligibility Criteria

• Age: 2 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Children's Hospital of Philapdelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Related Publications (32)

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• Wolfe J, Orellana L, Ullrich C, Cook EF, Kang TI, Rosenberg A, Geyer R, Feudtner C, Dussel V. Symptoms and Distress in Children With Advanced Cancer: Prospective Patient-Reported Outcomes From the PediQUEST Study. J Clin Oncol. 2015 Jun 10;33(17):1928-35. doi: 10.1200/JCO.2014.59.1222. Epub 2015 Apr 27.

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• Dussel V, Orellana L, Soto N, Chen K, Ullrich C, Kang TI, Geyer JR, Feudtner C, Wolfe J. Feasibility of Conducting a Palliative Care Randomized Controlled Trial in Children With Advanced Cancer: Assessment of the PediQUEST Study. J Pain Symptom Manage. 2015 Jun;49(6):1059-69. doi: 10.1016/j.jpainsymman.2014.12.010. Epub 2015 Jan 30.

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• Wolfe J, Orellana L, Cook EF, Ullrich C, Kang T, Geyer JR, Feudtner C, Weeks JC, Dussel V. Improving the care of children with advanced cancer by using an electronic patient-reported feedback intervention: results from the PediQUEST randomized controlled trial. J Clin Oncol. 2014 Apr 10;32(11):1119-26. doi: 10.1200/JCO.2013.51.5981. Epub 2014 Mar 10.

  PMID: 24616307 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Joanne Wolfe, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 19, 2013
• First Posted: April 24, 2013
• Study Start: November 1, 2004
• Primary Completion: December 1, 2009
• Study Completion: June 1, 2010
• Last Updated: April 29, 2013

Record last verified: 2013-04

Locations

US (4)