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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 Institute Children’s Innovation Institute, American Humane Association American Humane Association p: (303) 630-9480 | email: ashleighr@americanhumane.org p: (720) 446-9769| molly.jenkins@americanhumane.orgashleighr@americanhumane.orgmolly.jenkins@americanhumane.org 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 | amym@americanhumane.org and Treatment of Child Abuse & Neglectamym@americanhumane.org p: (303) 864-5219 | john.fluke@ucdenver.edu 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 H 1 : 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) H 2 : 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 Dogs H 3 : 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.