Distress in the Pediatric Oncology Setting: Intervention Versus Natural Adaptation

  • Interventional
  • Recruiting
  • NCT04409301
Eligibility Details Visit Clinicaltrials.gov

Distress in the Pediatric Oncology Setting: Intervention Versus Natural Adaptation - A Multi-Center Study

Children with cancer undergo many procedures as part of their treatment, and are often hospitalized or have frequent clinic visits, which can be distressing. Using robots or toys may be promising interventions as they provide elements of distraction therapy to children undergoing stressful and painful medical procedures. The purpose of this study is to see whether the use of a robotic toy called My Special Aflac Duck will reduce distress in children who have been diagnosed with cancer. This multi-center study will involve 20 children, ages 3-10, at each of 8 hospitals and their parent or guardian. There will be a total of 160 participants enrolled nationally.

Annually in the US, over 12,500 children and adolescents are diagnosed with cancer. Youth with cancer undergo numerous procedures, clinic visits, and hospitalizations as part of their treatment and are often hospitalized or frequently come to clinic for procedures and treatment. These events can be distressing and can contribute to a range of negative emotional and/or psychological outcomes. In younger children, coping with distress and anxiety is mediated by their level of cognitive development and affective regulation. Child Life Specialists assist patients and their families during medical experiences by providing individualized educational and emotional support. Distraction techniques, usually performed by Child Life professionals, appear to be better suited to the cognitive abilities of young children, however, the degree to which distraction results in long-term reductions of child distress has not been well-established. Parent(s)/families are also important factors to consider since they are often active in day-to-day care of pediatric cancer patients. Studies have shown that parents have an active role in supporting and training their children during procedures and aiding in interventions and/or during evaluations.

     Multisensory toys involving audiovisual, kinesthetic, and tactile senses, requiring a player's active cognitive, motor, and visual skills, have been utilized as an active distraction technique with the potential of reducing pain and anxiety. Robots are promising interventions as they provide elements of distraction to children undergoing stressful and painful medical procedures. In a previous feasibility study completed by the investigative team, results demonstrate high acceptability of My Special Aflac Duck (MSAD) as a device and as a method of distraction for children coping with treatment for pediatric cancer. In addition, the MSAD animatronic device was shown to provide a fun distraction and was used as a tool for expressing feelings for children with cancer in the hospital.

     This is a multi-center efficacy trial coordinated through the Aflac Cancer and Blood Disorder Center at Children's Healthcare of Atlanta (CHOA). Hospitals with pediatric oncology departments will be recruited and will be responsible for the enrollment of patients to participate in this study. All participating hospitals will have dedicated Child Life services. Randomized assignment for this trial will be performed at the hospital level. Four hospitals will be assigned to have patients receive the My Special Aflac Duck (MSAD) animatronic device at study initiation and four hospitals will be assigned to not have patients receive MSAD during the study but will receive MSAD at the end of the study.

     The study plans to enroll a total of 160 patients and their parent(s)/guardian(s). Within each hospital, 20 families will be recruited; 10 with children aged 3.00-6.99 years and 10 with children aged 7.00-10.99 years.


Age Group
3 Years to 10 Years

Accepting Healthy Volunteers?

Inclusion Criteria:

         - Children aged 3.00-10.99 years

         - All cancer diagnoses

         - English or Spanish speaking (parent and child)

        Exclusion Criteria:

         - Patients who receive surgery only will be excluded as they will not have follow-up visits at which to complete the questionnaires

         - Patients with cognitive or sensory deficits that would impact being able to interact with MSAD and/or complete questionnaires

         - Patients who receive chemotherapy entirely inpatient and never have appointments in the outpatient setting

At a Glance

National Government IDNCT04409301


Lead SponsorEmory University

Lead PhysicianAmi Desai


3 Years to 10 Years