Helping Improve Pediatric Patient Outcomes

Study Overview
=================
Brief Summary
-----------------
This study involves two distinct activities: The first is a randomized controlled trial (RCT) to assess the efficacy and safety of therapy dog visits for children with cancer. This activity has the following specific objectives: To assess the effect of therapy dog visits on psychosocial outcomes and satisfaction with care among pediatric oncology inpatients. To determine whether therapy dog visits increase microbial levels on children's hands. The Investigators hypothesize that therapy dog visits will reduce patient distress, lower treatment-related anxiety, increase happiness, and improve satisfaction with hospital care. The Investigators further hypothesize that therapy dog visits (including standard hand sanitization) will not increase microbial levels on children's hands. Once the main study aims for the first study activity have been completed, the research study team will begin recruitment for the second activity. The second activity is an observational study to describe microbial levels before a dog visit, after a dog visit but before hand cleaning, and after hand cleaning. This phase will provide additional information for Aim 2 that cannot be obtained during the RCT given the nature of the RCT design. The Investigators will proceed with the observational study only if all main study activities can be completed within the study timeline.

Detailed Description
-----------------
This study tests whether therapy dog visits reduce distress, lower treatment-related anxiety, increase happiness, and improve satisfaction with hospital care, and whether these visits transmit pathogens. The first activity is a randomized controlled trial (RCT) in which patients will be randomized to either the intervention (therapy dog visits) or control (usual care). All patients will complete a baseline survey and hand sampling (i.e., removal of materials of hands via use of liquid inside a glove) and answer questions from study staff (e.g., about pets at home, which hand is dominant) before randomization. Parents will also complete a baseline survey. Patients in the intervention group will receive therapy dog visits. At the first therapy dog visit after enrollment, the research study team will collect visit-level psychosocial measures and perform hand sampling. Similar procedures will be performed on usual care patients. Patients in the intervention group will receive subsequent dog visits  1x/week for up to 4 weeks if there sufficient dog team capacity. At hospital discharge,  3 days post-discharge and 9 weeks post-discharge, the research study team will administer surveys to patients and their parents in both groups. Informed consent/assent will be performed for patients who agree to participate in the study and preliminarily meet eligibility criteria. The parent/legal guardians of participants who are enrolled in will be approached for their informed consent to complete surveys. After informed consent/assent has been obtained, baseline surveys will be administered and hand samples will be collected. The study staff will then assess the patient's ability to tolerate and willingness to perform future psychological assessments and hand samplings. Patients willing to proceed with the study will be randomized to either the intervention arm (visits from a therapy dog) or the control arm (no visits from a therapy dog). Participants will be randomized (1:1) to each group and stratified by age (≥13 vs <13 years). Participants will maintain their randomization assignment during any subsequent hospitalizations that occur during their participation in the study. The second activity is an observational study of patients receiving therapy dog visits that will provide additional information on microbial levels. The observational study which involves a one-time therapy dog visit. Children will be instructed to touch the dog with both hands. Both hands will be sampled before the visit. A randomly selected hand will be sampled immediately after the visit (before hand sanitization). The other hand will be sampled after sanitization.

Official Title
-----------------
Psychological Benefits and Potential Pathogen Transmission in Hospitalized Pediatric Oncology Patients Receiving Therapy Dog Visits: a Randomized Controlled Trial

Conditions
-----------------
Pediatric Cancer, Animal-Assisted Activities

Intervention / Treatment
-----------------
* Behavioral: Therapy Dog Visit


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: English-speaking patients aged 5-17 years who have been admitted to the Seattle Children's Hospital Cancer Care Unit and who are on the oncology service irrespective of specific oncologic diagnosis, sex, race, and ethnicity. Exclusion Criteria: Are allergic to dogs or have a sensitivity to dogs; Are afraid of dogs; Are on the bone marrow transplant service; Have isolation precautions in place per Infection Prevention policies (e.g. viral respiratory precautions, contact precautions, etc.); Skin on hands not intact (e.g. moderate to severe eczema involving the hands or other generalized skin breakdown); Have no English-speaking parent/legal guardian; Have no parent/legal guardian able to provide written consent; For observational study, unwilling or unable to pet the dog with both hands.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therapy Dog Visits<br>Participants randomized to Therapy Dog Visits will receive a visit from a therapy dog and handler team up to one time per week for up to four weeks, depending on length of hospitalization and therapy dog team capacity. Therapy dog visits will last up to about 20 minutes and activities may include: petting the dog, watching the dog perform a trick, and talking with the dog handler. All activities will follow the current procedures and regulations in place at Seattle Children's Hospital. | Behavioral: Therapy Dog Visit<br>* Animal Assisted Activities (AAA) provide opportunities for motivational, educational, recreational, and/or therapeutic benefits to enhance quality of life. AAA are delivered in a variety of environments by specially trained professionals, paraprofessionals, and/or volunteers, in association with animals that meet specific criteria. Key features of AAA are as follows: Specific treatment goals are not planned for each visit. Volunteers and treatment providers are not required to take detailed notes. Visit content and activities are spontaneous. Visit length can be as long or as short as needed.<br>* Other names: Animal-Assisted Activities;|
| No Intervention: Control Group<br>Participants randomized to the Control Group will receive usual medical care. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales (PedsQL VAS) total distress score | The PedsQL VAS total score is a measure of present or in-the-moment distress. It is computed as the average of 6 scales (afraid/scared, sad/blue, angry, worry, tired, pain/hurt). Each scale ranges from 0-100, with lower scores indicating lower distress. For the overall score, lower values indicate lower total distress. | Immediately after first visit (Intention to Treat) | 
| Microbial load (colony forming units; cfu) on child hands | Microbial load on child hands | Immediately after first visit (Intention to Treat and Per Protocol) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales (PedsQL VAS) total distress score | The PedsQL VAS total score is a measure of present or in-the-moment distress. It is computed as the average of 6 scales (afraid/scared, sad/blue, angry, worry, tired, pain/hurt). Each scale ranges from 0-100, with lower scores indicating lower distress. For the overall score, lower values indicate lower total distress. | Immediately after first visit (Per Protocol) | 
| Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales (PedsQL VAS) individual scales (afraid/scared, sad/blue, angry, worry, tired, pain/hurt) | Each of 6 scales (afraid/scared, sad/blue, angry, worry, tired, pain/hurt) ranges from 0-100, with lower scores indicating a better outcome. | Immediately after first visit (Intention to Treat) | 
| Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales (PedsQL VAS) emotional distress summary score. | The PedsQL VAS emotional distress summary score is a measure of present or in-the-moment emotional distress. It is computed as the average of 4 scales (afraid/scared, sad/blue, angry, worry). Each scale ranges from 0-100, with lower scores indicating lower distress. For the overall score, lower values indicate lower emotional distress. | Immediately after first visit (Intention to Treat) | 
| Presence of Clinically Important Organisms | The presence of each of the following nine organisms: Staphylococcus aureus (further evaluated for methicillin-resistance); Vancomycin-resistant enterococci; Malassezia; Aspergillus; Pasteurella; Enterobacteriaceae (further assessed for multidrug resistance); Acinetobacter (further assessed for multidrug resistance); Pseudomonas aeruginosa (further assessed for multidrug resistance); Clostridium difficile | Immediately after first visit (Intention to Treat and Per Protocol) | 
| Pediatric Quality of Life Inventory (PedsQL) Cancer Module: treatment anxiety dimension | Treatment anxiety is one dimension measured within the PedsQL Cancer Module. It consists of 3 questions on a Likert scale. Items are reversed scored and linearly transformed on a 0-100 scale and then averaged. Higher scores indicate lower treatment anxiety. | Hospital discharge (hospital discharge date varies by patient), 3 days post-hospital discharge, and 9-weeks post-hospital discharge, (Intention to Treat) | 
| Patient feelings when thinking about being in the hospital (afraid/scared, sad/blue, angry; worried) | Each feeling (afraid/scared, sad/blue, angry, worried) is measured as either, not present, a little bit present, present, or strongly present. | Hospital discharge (hospital discharge date varies by patient), 3 days post-hospital discharge, and 9-weeks post-hospital discharge), (Intention to Treat) | 
| The Positive and Negative Affect Schedule (PANAS): parent measure of child's positive affect | The parent report of the child's positive affect consists of 5 positive feelings/emotions each scored on a 5-point Likert scale. Low scores represent worse outcomes. The total score (range: 5-25) is obtained by summing the items. | Primary: Hospital discharge (hospital discharge date varies by patient); secondary: 3 days post-hospital discharge and 9-weeks post-hospital discharge (Intention to Treat) | 
| The Positive and Negative Affect Schedule (PANAS): parent measure of child's negative affect | The parent report of the child's negative affect consists of 5 negative feelings/emotions each scored on a 5-point Likert scale. Low scores represent better outcomes. The total score (range: 5-25) is obtained by summing the items. | Primary: Hospital discharge (hospital discharge date varies by patient); secondary: 3 days post-hospital discharge and 9-weeks post-hospital discharge (Intention to Treat) | 
| Six-item short-form of the state scale of the Spielberger State-Trait Anxiety Inventory (STAI) | The short form of the Spielberger State-Trait Anxiety scale will be used to measure parent anxiety. It consists of six items, each on a 4-point Likert scale. The total score is obtained by reverse scoring the three positive items, summing the six scores together, and then multiplying by 20/6. Total scores range from 20 to 80 with higher numbers representing worse outcomes. | Immediately after first visit, (Intention to Treat) | 
| Parent rating of hospital | Parents rate the hospital on a 11-point Likert scale. Scores range from 0 to 10. Lower scores represent worse hospital ratings. | Primary: Hospital discharge (hospital discharge date varies by patient); secondary: 3 days post-hospital discharge and 9-weeks post-hospital discharge (Intention to Treat) | 
| Microbial load (colony forming units; cfu) on hands that touched the dog versus hands of medically eligible controls | Microbial load on hands that touched the dog versus hands of medically eligible controls | Immediately after first visit |