Clinical trial · Interventional
Distress in the Pediatric Oncology Setting: Intervention Versus Natural Adaptation
Distress in the Pediatric Oncology Setting: Intervention Versus Natural Adaptation - A Multi-Center Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pediatric Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| My Special Aflac Duck (MSAD) | Other | — | UNRESOLVED |
| Standard of care control | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- MSAD Intervention
- description
- Children receiving cancer treatment in a hospital randomized to the My Special Aflac Duck (MSAD) intervention.
- interventionNames
- Other: My Special Aflac Duck (MSAD)
- type
- ACTIVE_COMPARATOR
- label
- Control Group
- description
- Children receiving cancer treatment in a hospital randomized to be a control hospital. Children in the control hospitals will receive the My Special Aflac Duck (MSAD) at the end of the intervention period.
- interventionNames
- Behavioral: Standard of care control
Primary outcomes (1)
- measure
- Change in Parent Reported Patient Distress with Distress Thermometer
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 10 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available