Clinical trial NCT04409301: Distress in the Pediatric Oncology Setting: Intervention Versus Natural Adaptation
Official title: Distress in the Pediatric Oncology Setting: Intervention Versus Natural Adaptation - A Multi-Center Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Cancer
Keywords: Behavioral intervention
Medical setting distress
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: American Family Life Assurance Company (Aflac Inc.)
First posted: 2020-06-01
Enrollment: 160
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Hospitals will be randomized to deliver the intervention or to be a control site. Children will be enrolled to ensure equal sized groups of younger (ages 3-6) and older (ages 7-10) children.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Parent Reported Patient Distress with Distress Thermometer
timeFrame: Baseline, Week 1
Secondary outcomes:
measure: Change in Child-Reported Distress with Distress Thermometer
timeFrame: Baseline, Week 1, Month 1, Month 3
measure: Change in Patient Distress with Distress Thermometer as Reported by Child Life Specialists
timeFrame: Baseline, Week 1, Month 1, Month 3
measure: Change in Parent Report of Pediatric Quality of Life Inventory (PedsQL) - Generic Score
timeFrame: Baseline, Week 1, Month 1, Month 3
measure: Change Parent Reported in PedsQL - Cancer Module Score
timeFrame: Baseline, Week 1, Month 1, Month 3
measure: Change in Child Reported PedsQL - Cancer Module Score
timeFrame: Baseline, Week 1, Month 1, Month 3
measure: Change in Parent Reported Patient-Reported Outcomes Measurement Information System (PROMIS) - Psychological Stress Experiences Score
timeFrame: Baseline, Week 1, Month 1, Month 3
measure: Change in Child Reported PROMIS - Psychological Stress Experiences Score
timeFrame: Baseline, Week 1, Month 1, Month 3
measure: Change in Parent Reported PROMIS - Positive Affect Score
timeFrame: Baseline, Week 1, Month 1, Month 3
measure: Change in Child Reported PROMIS - Positive Affect Score
timeFrame: Baseline, Week 1, Month 1, Month 3
measure: Change in Parent Reported PROMIS - Pain Behavior Score
timeFrame: Baseline, Week 1, Month 1, Month 3
measure: Change in Child Life Specialist Reported Common Terminology Criteria for Adverse Events (CTCAE) - Anxiety
timeFrame: Baseline, Week 1, Month 1, Month 3
measure: Change in Child Life Specialist Reported Common Terminology Criteria for Adverse Events (CTCAE) - Pain
timeFrame: Baseline, Week 1, Month 1, Month 3
measure: Change in Parent Reported CTCAE - Depression Score
timeFrame: Baseline, Week 1, Month 1, Month 3
measure: Change in Child Reported CTCAE - Depression Score
timeFrame: Baseline, Week 1, Month 1, Month 3
measure: Change in Child Life Specialist Reported CTCAE - Depression Score
timeFrame: Baseline, Week 1, Month 1, Month 3
measure: Change in Brief Symptom Inventory 18 (BSI-18) Score
timeFrame: Baseline, Week 1, Month 1, Month 3
measure: Parent Reported Satisfaction with the MSAD Intervention
timeFrame: Baseline, Week 1, Month 1, Month 3
measure: Child Reported Satisfaction with the MSAD Intervention
timeFrame: Baseline, Week 1, Month 1, Month 3
measure: Child Life Specialist Reported Satisfaction with the MSAD Intervention
timeFrame: Baseline, Week 1, Month 1, Month 3
measure: Parent Reported Patterns of Utilization of the MSAD Intervention
timeFrame: Baseline, Week 1, Month 1, Month 3
measure: Child Life Specialist Reported Patterns of Utilization of the MSAD Intervention
timeFrame: Baseline, Week 1, Month 1, Month 3
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Children's of Alabama
state: Alabama
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
city: Chicago
country: United States
facility: Comer Children's Hospital
state: Illinois
city: New Orleans
country: United States
facility: Children's Hospital New Orleans
state: Louisiana
city: Ann Arbor
country: United States
facility: C.S. Mott Children's Hospital
state: Michigan
city: Kansas City
country: United States
facility: Children's Mercy Kansas City
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis Children's Hospital
state: Missouri
city: Richmond
country: United States
facility: Children's Hospital of Richmond
state: Virginia
Study officials:
affiliation: Emory University
name: Tamara Miller, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References: