Pediatric CancerMSADNCT04409301
Distress in the Pediatric Oncology Setting: Intervention Versus Natural Adaptation
A study testing My Special Aflac Duck (MSAD) in people with Pediatric Cancer, run by Emory University at 8 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Pediatric Cancer
- What is being tested?
- My Special Aflac Duck (MSAD)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 8 sitesUnited States
- Study dates
- 18 Sep 2020to 22 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 3.00-10.99 years
- All cancer diagnoses
- English or Spanish speaking (parent and child)
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
C.S. Mott Children's Hospital
Ann Arbor, Michigan, 48109
Children's of Alabama
Birmingham, Alabama, 35233
Comer Children's Hospital
Chicago, Illinois, 60637
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
Children's Mercy Kansas City
Kansas City, Missouri, 64108
Children's Hospital New Orleans
New Orleans, Louisiana, 70118
Children's Hospital of Richmond
Richmond, Virginia, 23219
St. Louis Children's Hospital
St Louis, Missouri, 63110
About this study
Official title: Distress in the Pediatric Oncology Setting: Intervention Versus Natural Adaptation - A Multi-Center Study
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.
Read the 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
- Being tested
- My Special Aflac Duck (MSAD), Standard of care control
- Keywords
- Behavioral intervention, Medical setting distress
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Standard of care controlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| MSAD Intervention | Experimental | Children receiving cancer treatment in a hospital randomized to the My Special Aflac Duck (MSAD) intervention. Receives: 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. Receives: Behavioral: Standard of care control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 1
Secondary outcomes (21)
Change in Child-Reported Distress with Distress Thermometer
Children will report patient medical setting distress with the 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.
Measured: Baseline, Week 1, Month 1, Month 3
Change in Patient Distress with Distress Thermometer as Reported by Child Life Specialists
Child Life Specialists will report patient medical setting distress with the 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.
Measured: Baseline, Week 1, Month 1, Month 3
Change in Parent Report of Pediatric Quality of Life Inventory (PedsQL) - Generic Score
Patient quality of life will be assessed with the generic PedsQL as reported by their parents. The parent report surveys for children aged 5-7 and aged 8-12 include 23 items asking about problems the child experienced in the last month. Responses are given on a scale from 0 (never) to 4 (almost always). Responses are reverse scored and linearly transformed to a scale from 0 to 100. The total scale score is the mean of responses, ranging from 0 to 100 where higher scores indicate better quality of life.
Measured: Baseline, Week 1, Month 1, Month 3
Change Parent Reported in PedsQL - Cancer Module Score
Patient quality of life will be assessed with the PedsQL Cancer Module. Parents will complete the parent report assessment corresponding with the age of their child. The instrument for children aged 5-7 has 26 items and the instrument for children ages 8-12 contains 27 items. Responses are given on a scale from 0 (never) to 4 (almost always). Responses are reverse scored and linearly transformed to a scale from 0 to 100. The total scale score is the mean of responses, ranging from 0 to 100 where higher scores indicate better quality of life concerning cancer.
Measured: Baseline, Week 1, Month 1, Month 3
Change in Child Reported PedsQL - Cancer Module Score
Patient quality of life will be assessed with the PedsQL Cancer Module. Children ages 5 and older will complete the child report assessment corresponding with their age. The instrument for children aged 5-7 has 26 items and the instrument for children ages 8-12 contains 27 items. Responses are given on a scale from 0 (never) to 4 (almost always). Responses are reverse scored and linearly transformed to a scale from 0 to 100. The total scale score is the mean of responses, ranging from 0 to 100 where higher scores indicate better quality of life concerning cancer.
Measured: Baseline, Week 1, Month 1, Month 3
Change in Parent Reported Patient-Reported Outcomes Measurement Information System (PROMIS) - Psychological Stress Experiences Score
Patient stress, as reported by parents, will be assessed with the PROMIS Parent Proxy Report for Pediatric Patients, Psychological Stress Experiences survey. This instrument includes 12 items asking about the child's feelings of stress. Responses are given on a scale of 1 to 5 where 1 = never and 5 = always. Total raw scores range from 12 to 60 with higher scores indicating greater experiences of psychological stress. The total raw score can be converted to a standardized T-score with a mean of 50 and a standard deviation of 10. T-scores greater than 50 indicate greater stress.
Measured: Baseline, Week 1, Month 1, Month 3
Change in Child Reported PROMIS - Psychological Stress Experiences Score
Patient stress, as self-reported by children aged 8 and older, will be assessed with the PROMIS Pediatric Psychological Stress Experiences instrument. This instrument includes 19 items with responses given on a scale from 1 (never) to 5 (always). Total raw scores range from 19 to 95 with higher scores indicating greater experiences of psychological stress. The total raw score can be converted to a standardized T-score with a mean of 50 and a standard deviation of 10. T-scores greater than 50 indicate greater stress.
Measured: Baseline, Week 1, Month 1, Month 3
Change in Parent Reported PROMIS - Positive Affect Score
Positive affect, as reported by parents, will be assessed with the PROMIS Positive Affect instrument. This survey contains 15 items for children ages 3-7 and 18 items for children ages 8-12. Responses given on a scale from 1 (not at all or a little bit) to 4 (very much). Total raw scores are standardized to a T-score with a mean of 100 and standard deviation of 15. Standardized scores greater than 100 indicate greater positive affect.
Measured: Baseline, Week 1, Month 1, Month 3
Change in Child Reported PROMIS - Positive Affect Score
Positive affect, as reported by children aged 8 years and older, will be assessed with the PROMIS Positive Affect instrument. This survey contains 9 items for children ages 8-12. Responses given on a scale from 1 (not at all) to 5 (very much). Total raw scores are standardized to a T-score with a mean of 100 and standard deviation of 15. Standardized scores greater than 100 indicate greater positive affect.
Measured: Baseline, Week 1, Month 1, Month 3
Change in Parent Reported PROMIS - Pain Behavior Score
Patient pain, as reported by parents, is assessed with the PROMIS survey for Pain Behavior. This instrument includes 51 items scored on a scale from 1 to 6 where 1 = had no pain and 6 = almost always had pain. Total raw scores range from 51 to 306. The total raw score can be converted to a standardized T-score with a mean of 50 and a standard deviation of 10. T-scores greater than 50 indicate greater pain.
Measured: Baseline, Week 1, Month 1, Month 3
Change in Child Life Specialist Reported Common Terminology Criteria for Adverse Events (CTCAE) - Anxiety
Patient anxiety is assessed by Child Life Specialists with the CTCAE survey for Anxiety. This instrument includes 3 items asking about the child's symptoms of anxiety. Responses are given on a 4-point scale where 1 = no symptoms and 4 = very bad symptoms. Summed scores range from 3 to 12, where higher scores indicate greater anxiety.
Measured: Baseline, Week 1, Month 1, Month 3
Change in Child Life Specialist Reported Common Terminology Criteria for Adverse Events (CTCAE) - Pain
Patient pain is assessed by Child Life Specialists with the CTCAE survey for Pain. This instrument includes 3 items asking about the child's symptoms of pain. Responses are given on a 4-point scale where 1 = no symptoms and 4 = very bad symptoms. Summed scores range from 3 to 12, where higher scores indicate greater pain.
Measured: Baseline, Week 1, Month 1, Month 3
Change in Parent Reported CTCAE - Depression Score
Parent report of their child's depression is assessed with the CTCAE survey for depression. This instrument includes 2 items asking about the child's symptoms of depression. Responses are given on a 4-point scale where 1 = no symptoms and 4 = very bad symptoms. Summed scores range from 2 to 8, where higher scores indicate greater depression.
Measured: Baseline, Week 1, Month 1, Month 3
Change in Child Reported CTCAE - Depression Score
Children ages 8 and older will self-report depression with the CTCAE survey for depression. This instrument includes 2 items asking about the symptoms of depression. Responses are given on a 4-point scale where 1 = no symptoms and 4 = very bad symptoms. Summed scores range from 2 to 8, where higher scores indicate greater depression.
Measured: Baseline, Week 1, Month 1, Month 3
Change in Child Life Specialist Reported CTCAE - Depression Score
Child Life Specialists will use the CTCAE survey for depression to assess depression in their patients. This instrument includes 2 items asking about the symptoms of depression. Responses are given on a 4-point scale where 1 = no symptoms and 4 = very bad symptoms. Summed scores range from 2 to 8, where higher scores indicate greater depression.
Measured: Baseline, Week 1, Month 1, Month 3
Change in Brief Symptom Inventory 18 (BSI-18) Score
Parent self-report of psychological distress is assessed with the BSI-18. The BSI-18 includes 18 items asking respondents to indicate how bothered they are by symptoms, on a scale from 0 (not at all) to 4 (extremely). The Global Severity Index is the sum of all scores and ranges from 0 to 72 where higher values indicate greater distress.
Measured: Baseline, Week 1, Month 1, Month 3
Parent Reported Satisfaction with the MSAD Intervention
Parents will report their satisfaction with the MSAD intervention in the context of psychosocial programming. Parents will be asked to indicate how satisfied they are with the MSAD for improving their child's adaptation to the medical setting since being diagnosed with cancer. Responses are given on a scale from 0 (extremely unsatisfied) to 10 (extremely satisfied).
Measured: Baseline, Week 1, Month 1, Month 3
Child Reported Satisfaction with the MSAD Intervention
Children aged 8 years and older will report their satisfaction with the MSAD on a scale from 0 (extremely unsatisfied) to 10 (extremely satisfied).
Measured: Baseline, Week 1, Month 1, Month 3
Child Life Specialist Reported Satisfaction with the MSAD Intervention
Child Life Specialists will report their satisfaction with the MSAD intervention in the context of psychosocial programming. Child Life Specialists will be asked to indicate how satisfied they are with the MSAD for improving their patient's adaptation to the medical setting since being diagnosed with cancer. Responses are given on a scale from 0 (extremely unsatisfied) to 10 (extremely satisfied).
Measured: Baseline, Week 1, Month 1, Month 3
Parent Reported Patterns of Utilization of the MSAD Intervention
Parents will report on the utilization of the MSAD intervention in the context of psychosocial programming, by indicating how many minutes per day their child engages with the MSAD in the medical setting.
Measured: Baseline, Week 1, Month 1, Month 3
Child Life Specialist Reported Patterns of Utilization of the MSAD Intervention
Child Life Specialists will report on the utilization of the MSAD intervention in the context of psychosocial programming, by indicating how many minutes per day their patient engages with the MSAD in the medical setting.
Measured: Baseline, Week 1, Month 1, Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start18 Sep 2020
- Primary completion24 Oct 2023
- Study completion22 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Aflac Incorporated
- Responsible party
- Principal investigator, Tamara Miller, Emory University
- Investigators
- Tamara Miller, MD, MSCE, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04409301
- Sponsor's protocol ID
- IRB00116385
- Acronym
- MSAD
- Status last verified
- Feb 2024
- First submitted
- 27 May 2020
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distress in the Pediatric Oncology Setting: Intervention Versus Natural Adaptation - A Multi-Center Study
- ClinicalTrials.gov ID
- NCT04409301
- Acronym / sponsor ID
- MSAD / IRB00116385
- Conditions
- Pediatric Cancer
- Keywords
- Behavioral intervention, Medical setting distress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Aflac Incorporated
- Study start
- 18 Sep 2020 (actual)
- Primary completion
- 24 Oct 2023 (actual)
- Study completion
- 22 Jan 2024 (actual)
- First posted
- 1 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| MSAD Intervention | Experimental | Other: My Special Aflac Duck (MSAD)Children receiving cancer treatment in a hospital randomized to the My Special Aflac Duck (MSAD) intervention. |
| Control Group | Active comparator | Behavioral: Standard of care controlChildren 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. |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 3.00-10.99 years
- All cancer diagnoses
- English or Spanish speaking (parent and child)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | MSAD Intervention |
| Standard of care controlSites 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. | Behavioural | Control Group |
Primary outcome
Change in Parent Reported Patient Distress with Distress Thermometer
Time frame: Baseline, Week 1
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.
21 secondary outcomes
Change in Child-Reported Distress with Distress Thermometer
Time frame: Baseline, Week 1, Month 1, Month 3
Change in Patient Distress with Distress Thermometer as Reported by Child Life Specialists
Time frame: Baseline, Week 1, Month 1, Month 3
Change in Parent Report of Pediatric Quality of Life Inventory (PedsQL) - Generic Score
Time frame: Baseline, Week 1, Month 1, Month 3
Change Parent Reported in PedsQL - Cancer Module Score
Time frame: Baseline, Week 1, Month 1, Month 3
Change in Child Reported PedsQL - Cancer Module Score
Time frame: Baseline, Week 1, Month 1, Month 3
Change in Parent Reported Patient-Reported Outcomes Measurement Information System (PROMIS) - Psychological Stress Experiences Score
Time frame: Baseline, Week 1, Month 1, Month 3
Change in Child Reported PROMIS - Psychological Stress Experiences Score
Time frame: Baseline, Week 1, Month 1, Month 3
Change in Parent Reported PROMIS - Positive Affect Score
Time frame: Baseline, Week 1, Month 1, Month 3
Change in Child Reported PROMIS - Positive Affect Score
Time frame: Baseline, Week 1, Month 1, Month 3
Change in Parent Reported PROMIS - Pain Behavior Score
Time frame: Baseline, Week 1, Month 1, Month 3
Change in Child Life Specialist Reported Common Terminology Criteria for Adverse Events (CTCAE) - Anxiety
Time frame: Baseline, Week 1, Month 1, Month 3
Change in Child Life Specialist Reported Common Terminology Criteria for Adverse Events (CTCAE) - Pain
Time frame: Baseline, Week 1, Month 1, Month 3
Change in Parent Reported CTCAE - Depression Score
Time frame: Baseline, Week 1, Month 1, Month 3
Change in Child Reported CTCAE - Depression Score
Time frame: Baseline, Week 1, Month 1, Month 3
Change in Child Life Specialist Reported CTCAE - Depression Score
Time frame: Baseline, Week 1, Month 1, Month 3
Change in Brief Symptom Inventory 18 (BSI-18) Score
Time frame: Baseline, Week 1, Month 1, Month 3
Parent Reported Satisfaction with the MSAD Intervention
Time frame: Baseline, Week 1, Month 1, Month 3
Child Reported Satisfaction with the MSAD Intervention
Time frame: Baseline, Week 1, Month 1, Month 3
Child Life Specialist Reported Satisfaction with the MSAD Intervention
Time frame: Baseline, Week 1, Month 1, Month 3
Parent Reported Patterns of Utilization of the MSAD Intervention
Time frame: Baseline, Week 1, Month 1, Month 3
Child Life Specialist Reported Patterns of Utilization of the MSAD Intervention
Time frame: Baseline, Week 1, Month 1, Month 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Individual participant dataSharing planned: No
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Knowledge, Attitudes, Practice
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tamara Miller, MD, MSCE principal investigator
Emory University
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing My Special Aflac Duck (MSAD) in people with Pediatric Cancer, run by Emory University at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Parent Reported Patient Distress with Distress Thermometer (time frame: Baseline, Week 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.