ABSTRACT
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Implementation of a Replicable Animal-Assisted Intervention Protocol in Pediatric Oncology Settings
In the past 20 years, childhood cancer rates have increased slightly, but advances in treatment options have led to greater survivorship for nearly all forms of childhood cancers. These improved survival rates have brought forth a plethora of new challenges for both children and families as they undergo cancer treatment, often a long-term process. In an effort to address these complex medical, behavioral and psychosocial issues, American Humane Association, with funding from Pfizer Animal Health, has partnered with three children's hospitals across the country to implement a complementary health practice in the form of a replicable animal-assisted therapy intervention. For the purposes of this pilot study, we are utilizing a randomized control trial design. We anticipate that this landmark study, Canines and Childhood Cancer (CCC): Examining the Effects of Therapy Dogs with Childhood Cancer Patients and their Families, will provide valuable information to the growing evidence-base in the field of animal-assisted interventions.
ABSTRACT
STUDY AIMS
• To address the feasibility of conducting a randomized control trial utilizing AAT within a pediatric healthcare setting• To determine how to address issues of scientific integrity and protocol fidelity• To ensure the validity of the six month/26 week pilot study• To develop recommendations for revisions to the protocol leading up to a final research protocol for a full 12-18 month clinical trial• To provide sites with an opportunity to become familiar with—and trained in—the aspects of the protocol in preparation for possible participation
in the full clinical trial
PILOT STUDY GOALS
Children• Observational Scale of Behavioral Distress (OSBD): a scale developed to measure children’s responses to painful medical procedures• Polar RS800CX training watch/Polar WearLink W.I.N.D. transmitter (outpatient) or an EKG (inpatient): to measure heart rate variability• Blood pressure cuff: to measure systolic and diastolic blood pressure
Parents/Primary Caregivers• State Trait Anxiety Inventory (STAI): a questionnaire that differentiates between current state anxiety and more inherent trait or character anxiety • Pediatric Inventory for Parents (PIP): a questionnaire to specifically measure stress in parents/caregivers who are dealing with a critically ill child,
particularly a child with cancer• Polar RS800CX training watch/Polar WearLink W.I.N.D. transmitter: to measure heart rate variability
Measuring Distress in Therapy Dogs• Handler self-reports: regarding their dog’s behavior, the dog’s reaction to the family (and vice versa), activities that took place during the session,
session participants, and other pertinent notes • Salivary cortisol: handlers will collect their dog’s saliva after each session (these will be compared to a baseline measurement obtained at or before
the animal-handler team’s enrollment in the study)• AAT Ethogram: video cameras may be used to record sessions so that independent observers can document the dog’s behavioral cues utilizing the
AAT Ethogram
MEASURES
METHODS
• We are utilizing a randomized controlled trial and multi-site design at three hospitals for the pilot study.
• One group at each hospital site will receive the AAT intervention and one group will not; both will receive the standard-of-care for ALL patients.
• Therapy dogs are to be introduced no later than treatment day 15, but preferably at the time of diagnosis or within the first week.
• Each child will be matched with same animal-handler team over the course of the pilot.
• The AAT session will last for approximately 20 minutes on a weekly basis or during the child’s regularly scheduled appointment - visits will be more frequent during the first month of the child’s treatment.
• The data collection process will be more intensive during the initial induction therapy, occurring during the first month after the child’s diagnosis.
• After the induction therapy phase has been completed, the data collection process will become less frequent with the battery of measures being administered during the critical treatment days outlined in the COG protocol for up to 26 weeks, until the study’s completion or the patient/family drops out, whichever occurs first (see chart below).
ACKNOWLEDGEMENTS/CONTACT INFORMATION
All of the information presented is owned by Pfizer Animal Health and American Humane Association.
To learn more about the study or to get involved please contact:
Ashleigh Ruehrdanz Molly Jenkins, M.S.W.Research and Evaluation Specialist & IRB Administrator Research Analyst, Children’s Innovation InstituteChildren’s Innovation Institute, American Humane Association American Humane Associationp: (303) 630-9480 | email: [email protected] p: (720) 446-9769| [email protected]
Amy McCullough, M.A. John Fluke, Ph.D. (Principal Investigator)National Director, Animal-Assisted Therapy Associate Director for Systems Research and Evaluation American Humane Association Department of Pediatrics, Kempe Center for the Prevention p: 303-476-3613 | [email protected] and Treatment of Child Abuse & Neglect p: (303) 864-5219 | [email protected]
Empirical evidence shows that interaction with animals during can be beneficial in a variety of settings (Fine, 2010; Friedmann, Son, & Tsai, 2010; McCardle, McCune, Griffin, Esposito & Freund, 2011; Nimer & Lundahl, 2007; Serpell, 2006; Tsai, Friedmann, & Thomas, 2010; Wells, 2009). We aim to document the health and well-being effects of AAT by determining: • The biological and psychosocial impacts of therapy dogs on children
with cancer• The biological and psychosocial impacts of therapy dogs on families
(primarily caregivers, such as parents, grandparents or other relatives) of children with cancer
• The biological and behavioral impacts of AAT sessions on participating therapy dogs
Ashleigh Ruehrdanz, Molly Jenkins, M.S.W., Amy McCullough, M.A., and John Fluke, Ph.D.
HYPOTHESES
Children H1: Pediatric cancer patients with Acute Lymphoblastic Leukemia (ALL) who receive AAT will experience less distress throughout the course of
their treatment sessions than patients who do not receive AAT.
Families (parent(s)/primary caregivers)H2: Parent(s)/primary caregivers of pediatric cancer patients with ALL who receive AAT will experience less distress throughout the course of their child’s treatment sessions than parent(s)/primary caregivers of patients who do not receive AAT.
Therapy DogsH3: Participating therapy dogs will exhibit minimal distress over the course of the CCC study.
STUDY POPULATION
Our patient population for the pilot is children aged 3 through 11 years who are newly diagnosed with Acute Lymphoblastic Leukemia (ALL). Based on existing admissions data from each of the three pilot sites, the research team anticipates that up to 20 patients (or ~6-7 patients/site) may participate in the six month/26 week pilot trial. The patient population was selected for the following reasons:
• ALL is the most common form of childhood cancer• ALL patients typically experience a common treatment protocol under the Children’s Oncology Group, that is consistently used at all sites enrolled in
the pilot study• Aside from consistently utilized medication, ALL treatment does not involve procedures that may directly impact neural function or development• Age three is within the peak age range for diagnosis of ALL• According to focus group findings, older children and adolescents (e.g., > age 11) may not have a strong emotional response to therapy dogs The parent/caregiver population for the pilot will be the individual(s) who are identified as the eligible child’s primary caregiver.(s) The study coordinator will identify these individuals after their child has been determined to be eligible for the study. The animal-handlers and their dogs will make up the other segment of our study population. The animal-handlers will be recruited and selected by American Humane Association staff in conjunction with the study coordinator, volunteer coordinators and AAT volunteer leads at each of the pilot sites.
Diagnosis
• Informed Consent Process
• Informed Assent Process
Sta te Trai t Anxiety Inventory, Pedia tric
Inventory for Parents a nd Hea rt Ra te Varia bi l i ty
once every two months (to coi ncide with cri tica l
treatment da y)
Sta te Trai t Anxiety Inventory, Pedi atric
Inventory for Parents a nd Hea rt Ra te Varia bi l i ty
once every two months (to coi nci de with cri tica l
treatment da y)
Instrumentation Schedule ADULTS
Sta te Tra it Anxi ety Inventory, Pedi atric
Inventory for Parents a nd Hea rt Ra te Varia bi l i ty on
criti cal treatment da ys
Sta te Tra it Anxiety Inventory, Pedi atric
Inventory for Parents and Heart Rate
Va ri abi l i ty once every two months (to
coincide wi th criti cal trea tment da y)
Sta te Trai t Anxiety Inventory, Pedia tri c
Inventory for Parents a nd Hea rt Ra te Varia bi l i ty once
every two months (to coi ncide with criti ca l
treatment da y)
Sta te Trait Anxi ety Inventory, Pedia tri c
Inventory for Parents a nd Heart Rate Vari abi l i ty once
every two months (to coinci de with criti ca l
treatment da y)
Interim Maintenance Therapy (8 weeks)
OSBD, Hea rt Rate Va ria bi l i ty and blood
pressure once every two months (to coinci de with
cri tica l trea tment day)
Instrumentation Schedule KIDS
OSBD, Hea rt Ra te Varia bi l i ty and blood
pressure on criti cal trea tment da ys ;
OSBD, Heart Ra te Va ri abi l i ty and blood pressure once every
two months (to coincide wi th criti cal
trea tment day)
OSBD, Heart Ra te Va ri abi l i ty a nd bl ood
pressure once every two months (to coinci de with
criti cal trea tment da y)
OSBD, Hea rt Ra te Va ri abi l i ty a nd blood
pres sure once every two months (to coinci de with
criti cal treatment da y)
OSBD, Hea rt Rate Va ria bi l i ty and blood
pressure once every two months (to coincide wi th
cri tica l trea tment day)
•Vi s i t by therapy dog and ani ma l handl er for ~20 minutes on cri ti ca l
trea tment da ys or a mi nimum of once per
week
•Vi s i t by therapy dog a nd animal handl er for ~20
mi nutes on criti cal trea tment da ys or a
mi nimum of once per week
•Vis i t by therapy dog and ani ma l handl er for ~20
mi nutes on criti ca l treatment da ys or a
mi ni mum of once per week
•Vi s i t by therapy dog and anima l handl er for ~20
mi nutes on criti ca l trea tment days or a
mi ni mum of once per week
•Vi s i t by therapy dog and animal handl er for ~20
minutes on criti cal treatment days or a
mi ni mum of once per week
AAT Intervention Strategy
•Introduce thera py dog no later than da y 15,
preferably on trea tment da y 1; vi s i t by therapy dog
and a ni ma l ha ndler for ~20 minutes duri ng criti cal trea tment
da ys/procedures or a mi nimum of once per
week
Inpatient OutpatientTypi ca l Trea tment
Loca tion:
Trea tment Pha se:
Cri ti ca l Trea tment and Data Col lection Da ys : Days 1, 4, 8, 15, 22, 29 Days 1, 8, 15 Days 1, 11, 21, 31, 41 Days 1-7, 1 5-21, 29, 29-42 Days 1, 11, 21, 31, 41
4 randomized treatment arms with varying days of
meds
Delayed Intensification Therapy (8 weeks)
Interim Maintenance Therapy (8 weeks)
Maintenance Therapy (up to 3 years)
Consolidation Therapy (4 weeks)
Induction Therapy - (4 weeks/1 month)
Handler Sel f-Report after ea ch ses s ion; Ca ni ne Sa l i va ry Corti sol and
Videota pi ng of Therapy Dog Behavi or Duri ng
Sess ion once every two months (to coincide wi th
cri tica l trea tment day)
Handler Sel f-Report after ea ch sess ion; Ca ni ne Sal ivary Cortisol a nd
Vi deotaping of Therapy Dog Behavior During
Sess ion once every two months (to coinci de with
cri tica l trea tment day)
Instrumentation Schedule Animal-Handlers and
Dogs
Ha ndler Sel f-Report, Canine Sa l i va ry Corti sol , Vi deota pi ng of Therapy
Dog Beha vior During Sess i on
Handl er Sel f-Report after ea ch sess ion;
Ca ni ne Sal ivary Corti sol and
Vi deotaping of Thera py Dog Behavior During
Sess ion once every two months (to coincide
wi th criti cal treatment da y)
Ha ndler Sel f-Report after ea ch sess i on; Canine Sal ivary Cortis ol a nd
Vi deotaping of Therapy Dog Behavior During
Sess i on once every two months (to coinci de with
criti cal trea tment da y)
Handl er Sel f-Report a fter ea ch sess ion; Cani ne Sa l iva ry Corti sol and
Vi deotapi ng of Therapy Dog Behavior During
Sess i on once every two months (to coinci de with
criti cal treatment da y)