My Special Aflac Duck (MSAD) for Pediatric Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Pediatric CancerMy Special Aflac Duck (MSAD) - Other
Eligibility
3 - 10
All Sexes
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Study Summary

This trial will test whether the use of a toy robot, the My Special Aflac Duck, can help to relieve stress in children who have cancer.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 21 Secondary · Reporting Duration: Baseline, Week 1, Month 1, Month 3

Baseline, Week 1
Change in Parent Reported Patient Distress with Distress Thermometer
Month 3
Change Parent Reported in PedsQL - Cancer Module Score
Change in Brief Symptom Inventory 18 (BSI-18) Score
Change in Child Life Specialist Reported CTCAE - Depression Score
Change in Child Life Specialist Reported Common Terminology Criteria for Adverse Events (CTCAE) - Anxiety
Change in Child Life Specialist Reported Common Terminology Criteria for Adverse Events (CTCAE) - Pain
Change in Child Reported CTCAE - Depression Score
Change in Child Reported PROMIS - Positive Affect Score
Change in Child Reported PROMIS - Psychological Stress Experiences Score
Change in Child Reported PedsQL - Cancer Module Score
Change in Child-Reported Distress with Distress Thermometer
Change in Parent Report of Pediatric Quality of Life Inventory (PedsQL) - Generic Score
Change in Parent Reported CTCAE - Depression Score
Change in Parent Reported PROMIS - Pain Behavior Score
Change in Parent Reported PROMIS - Positive Affect Score
Change in Parent Reported Patient-Reported Outcomes Measurement Information System (PROMIS) - Psychological Stress Experiences Score
Change in Patient Distress with Distress Thermometer as Reported by Child Life Specialists
Child Life Specialist Reported Patterns of Utilization of the MSAD Intervention
Child Life Specialist Reported Satisfaction with the MSAD Intervention
Child Reported Satisfaction with the MSAD Intervention
Parent Reported Patterns of Utilization of the MSAD Intervention
Parent Reported Satisfaction with the MSAD Intervention

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Control Group
1 of 2
MSAD Intervention
1 of 2

Active Control

Experimental Treatment

160 Total Participants · 2 Treatment Groups

Primary Treatment: My Special Aflac Duck (MSAD) · No Placebo Group · N/A

MSAD Intervention
Other
Experimental Group · 1 Intervention: My Special Aflac Duck (MSAD) · Intervention Types: Other
Control Group
Behavioral
ActiveComparator Group · 1 Intervention: Standard of care control · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, week 1, month 1, month 3

Who is running the clinical trial?

American Family Life Assurance Company (Aflac Inc.)UNKNOWN
Emory UniversityLead Sponsor
1,509 Previous Clinical Trials
2,705,846 Total Patients Enrolled
Tamara Miller, MD, MSCEPrincipal Investigator - Emory University
Medical School - Emory University, Doctor of Medicine
University of South Carolina (Residency)
1 Previous Clinical Trials
118 Total Patients Enrolled

Eligibility Criteria

Age 3 - 10 · All Participants · 3 Total Inclusion Criteria

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