Distress in the Pediatric Oncology Setting: Intervention Versus Natural Adaptation

NCT ID: NCT04409301

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-18
• Study Completion Date: 2024-01-22

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.

Conditions

Pediatric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

MSAD Intervention

Children receiving cancer treatment in a hospital randomized to the My Special Aflac Duck (MSAD) intervention.

Group Type: EXPERIMENTAL

My Special Aflac Duck (MSAD)

Intervention Type: OTHER

The hospital Child Life Specialist or research team member will introduce the child and parent to My Special Aflac Duck MSAD), with instructions on how to use the duck. MSAD is a robotic toy with an associated app. Children can use MSAD for play, exploring feelings, and describing medical procedures. Intervention hospitals are permitted to provide their standard of care from Child Life with the exception of providing stuffed animal-like objects. Data will be recorded by Child Life or research team member on what tools are used outside of the MSAD.

Control Group

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.

Group Type: ACTIVE_COMPARATOR

Standard of care control

Intervention Type: BEHAVIORAL

Sites will follow their individual standard of care from Child Life. Data will be recorded by Child Life on what tools are used. After completion of the 3-month survey, patients at hospitals assigned to not initially receive MSAD will each receive a MSAD.

Interventions

My Special Aflac Duck (MSAD)

The hospital Child Life Specialist or research team member will introduce the child and parent to My Special Aflac Duck MSAD), with instructions on how to use the duck. MSAD is a robotic toy with an associated app. Children can use MSAD for play, exploring feelings, and describing medical procedures. Intervention hospitals are permitted to provide their standard of care from Child Life with the exception of providing stuffed animal-like objects. Data will be recorded by Child Life or research team member on what tools are used outside of the MSAD.

Intervention Type: OTHER

Standard of care control

Sites will follow their individual standard of care from Child Life. Data will be recorded by Child Life on what tools are used. After completion of the 3-month survey, patients at hospitals assigned to not initially receive MSAD will each receive a MSAD.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Family Life Assurance Company (Aflac Inc.)

UNKNOWN

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Tamara Miller

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tamara Miller, MD, MSCE

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Children's of Alabama

Birmingham, Alabama, United States

Connecticut Children's Medical Center

Hartford, Connecticut, United States

Comer Children's Hospital

Chicago, Illinois, United States

Children's Hospital New Orleans

New Orleans, Louisiana, United States

C.S. Mott Children's Hospital

Ann Arbor, Michigan, United States

Children's Mercy Kansas City

Kansas City, Missouri, United States

St. Louis Children's Hospital

St Louis, Missouri, United States

Children's Hospital of Richmond

Richmond, Virginia, United States

Countries

United States

Other Identifiers

IRB00116385

Identifier Type: -

Identifier Source: org_study_id