title: Feasibility of Conducting a Palliative Care Randomized Controlled Trial in Children With Advanced Cancer: Assessment of the PediQUEST Study.
abstract: BACKGROUND
  Pediatric palliative care randomized controlled trials (PPC-RCTs) are uncommon.
  
  
  OBJECTIVE
  To evaluate the feasibility of conducting a PPC-RCT in pediatric cancer patients.
  
  
  METHODS
  This was a cohort study embedded in the Pediatric Quality of Life and Evaluation of Symptoms Technology Study (NCT01838564). This multicenter PPC-RCT evaluated an electronic patient-reported outcomes system. Children aged two years and older, with advanced cancer, and potentially eligible for the study were included. Outcomes included: pre-inclusion attrition (patients not approached, refusals); post-inclusion attrition (drop-out, elimination, death, and intermittent attrition (IA; missing surveys) over nine months of follow-up); child/teenager self-report rates; and, reasons to enroll/participate.
  
  
  RESULTS
  Over five years, of the 339 identified patients, 231 were eligible (in 22, we could not verify eligibility); 84 eligible patients were not approached and 43 declined participation. Patients not approached were more likely to die or have brain tumors. We enrolled 104 patients. Average enrollment rate was one patient per site per month; shortening follow-up from nine to three months (with optional re-enrollment) increased recruitment by 20%. A total of 87 patients completed the study (24 died) and 17 dropped out. Median IA was 41% in the first 20 weeks of follow-up and more than 60% in the eight weeks preceding death. Child/teenager self-report was 94%. Helping others, low burden procedures, incentives, and staff attitude were frequent reasons to enroll/participate.
  
  
  CONCLUSIONS
  A PPC-RCT in children with advanced cancer was feasible, post-inclusion retention adequate; many families participated for altruistic reasons. Strategies that may further PPC-RCT feasibility include: increasing target population through large multicenter studies, approaching sicker patients, preventing exclusion of certain patient groups, and improving data collection at end of life.
authors: Department of Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, Massachusetts, USA; Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina.
authors: Veronica
authors: V
authors: Dussel
authors: Biostatistics Unit Faculty of Health, Deakin University, Victoria, Australia.
authors: Liliana
authors: L
authors: Orellana
authors: Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina.
authors: Natalie
authors: N
authors: Soto
authors: Center for Outcomes and Policy Research, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.
authors: Kun
authors: K
authors: Chen
authors: Department of Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, Massachusetts, USA; Center for Outcomes and Policy Research, Dana-Farber Cancer Institute, Boston, Massachusetts, USA; Department of Medicine, Boston Children's Hospital, Boston, Massachusetts, USA; Harvard Medical School, Boston, Massachusetts, USA.
authors: Christina
authors: C
authors: Ullrich
authors: Department of Pediatrics, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA; Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, USA.
authors: Tammy I
authors: TI
authors: Kang
authors: Division of Pediatric Hematology/Oncology, Seattle Children's Hospital, Seattle, Washington, USA; Fred Hutchinson Cancer Research Center, Seattle, Washington, USA; University of Washington, Seattle, Washington, USA.
authors: Jeffrey R
authors: JR
authors: Geyer
authors: Department of Pediatrics, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA; Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, USA.
authors: Chris
authors: C
authors: Feudtner
authors: Department of Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, Massachusetts, USA; Center for Outcomes and Policy Research, Dana-Farber Cancer Institute, Boston, Massachusetts, USA; Department of Medicine, Boston Children's Hospital, Boston, Massachusetts, USA; Harvard Medical School, Boston, Massachusetts, USA. Electronic address: joanne_wolfe@dfci.harvard.edu.
authors: Joanne
authors: J
authors: Wolfe
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D009369:Neoplasms / Q000628:therapy*; D010166:Palliative Care / Q000379:methods; D010352:Patient Dropouts; D018579:Patient Selection; D010865:Pilot Projects; D013727:Terminal Care
keywords: Pediatrics; attrition; end-of-life care; feasibility; palliative care; patient-reported outcomes; pediatric oncology; randomized controlled trial; supportive care
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