title: Conducting a randomized clinical trial of an psychological intervention for parents/caregivers of children with cancer shortly after diagnosis.
abstract: OBJECTIVE
  To report acceptability, feasibility, and outcome data from a randomized clinical trial (RCT) of a brief intervention for caregivers of children newly diagnosed with cancer.
  
  
  METHODS
  Eighty-one families were randomly assigned following collection of baseline data to Intervention or Treatment as Usual (TAU). Recruitment and retention rates and progression through the protocol were tracked. Measures of state anxiety and posttraumatic stress symptoms served as outcomes.
  
  
  RESULTS
  Difficulties enrolling participants included a high percentage of newly diagnosed families failing to meet inclusion criteria (40%) and an unexpectedly low participation rate (23%). However, movement through the protocol was generally completed in a timely manner and those completing the intervention provided positive feedback. Outcome data showed no significant differences between the arms of the RCT.
  
  
  CONCLUSIONS
  There are many challenges inherent in conducting a RCT shortly after cancer diagnosis. Consideration of alternative research designs and optimal timing for interventions are essential next steps.
authors.affiliation: Division of Oncology, The Children's Hospital of Philadelphia, Philadelphia, PA 19104-4399, USA.
authors.forename: Meredith Lutz
authors.initials: ML
authors.lastname: Stehl
authors.forename: Anne E
authors.initials: AE
authors.lastname: Kazak
authors.forename: Melissa A
authors.initials: MA
authors.lastname: Alderfer
authors.forename: Alyssa
authors.initials: A
authors.lastname: Rodriguez
authors.forename: Wei-Ting
authors.initials: WT
authors.lastname: Hwang
authors.forename: Ahna L H
authors.initials: AL
authors.lastname: Pai
authors.forename: Alexandra
authors.initials: A
authors.lastname: Boeving
authors.forename: Anne
authors.initials: A
authors.lastname: Reilly
mesh_terms: D000223:Adaptation, Psychological; D000293:Adolescent; D001007:Anxiety / Q000175:diagnosis / Q000523:psychology* / Q000628:therapy*; D002648:Child; D003469:Culture; D003863:Depression / Q000175:diagnosis / Q000523:psychology* / Q000628:therapy*; D005196:Family Therapy; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D009369:Neoplasms / Q000175:diagnosis* / Q000523:psychology* / Q000628:therapy; D010290:Parents / Q000193:education / Q000523:psychology*; D018579:Patient Selection; D010555:Personality Inventory / Q000706:statistics & numerical data; D011594:Psychometrics; D011615:Psychotherapy, Group; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D013313:Stress Disorders, Post-Traumatic / Q000175:diagnosis / Q000523:psychology* / Q000628:therapy*