Distress in the Pediatric Oncology Setting: Intervention Versus Natural Adaptation

NCT04409301 | Completed

• 1 other identifier: IRB00116385
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 8

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.

Conditions

Pediatric Cancer

Keywords

Behavioral intervention; Medical setting distress

Outcome Measures

Primary Outcomes (1)

• Change in Parent Reported Patient Distress with Distress Thermometer

  The Distress Thermometer instrument asks respondents to indicate how much distress they are experiencing on a scale from 0 to 10 where 0 = no distress and 10 = extreme distress. Parents will report how much medical setting distress that they observe their children experiencing.

  Baseline, Week 1

Secondary Outcomes (21)

• Change in Child-Reported Distress with Distress Thermometer

  Baseline, Week 1, Month 1, Month 3

• Change in Patient Distress with Distress Thermometer as Reported by Child Life Specialists

  Baseline, Week 1, Month 1, Month 3

• Change in Parent Report of Pediatric Quality of Life Inventory (PedsQL) - Generic Score

  Baseline, Week 1, Month 1, Month 3

• Change Parent Reported in PedsQL - Cancer Module Score

  Baseline, Week 1, Month 1, Month 3

• Change in Child Reported PedsQL - Cancer Module Score

  Baseline, Week 1, Month 1, Month 3

Study Arms (2)

MSAD Intervention

EXPERIMENTAL

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

Other: My Special Aflac Duck (MSAD)

Control Group

ACTIVE COMPARATOR

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.

Behavioral: Standard of care control

Interventions

My Special Aflac Duck (MSAD) 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.

MSAD Intervention

Standard of care control 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.

Control Group

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 3.00-10.99 years
• All cancer diagnoses
• English or Spanish speaking (parent and child)

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• American Family Life Assurance Company (Aflac Inc.): collaborator

Study Sites (8)

Children's of Alabama

Birmingham, Alabama, 35233, United States

Location

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

Comer Children's Hospital

Chicago, Illinois, 60637, United States

Location

Children's Hospital New Orleans

New Orleans, Louisiana, 70118, United States

Location

C.S. Mott Children's Hospital

Ann Arbor, Michigan, 48109, United States

Location

Children's Mercy Kansas City

Kansas City, Missouri, 64108, United States

Location

St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

Children's Hospital of Richmond

Richmond, Virginia, 23219, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Tamara Miller, MD, MSCE

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 27, 2020
• First Posted: June 1, 2020
• Study Start: September 18, 2020
• Primary Completion: October 24, 2023
• Study Completion: January 22, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)