Clinical trial NCT03471221: Helping Improve Pediatric Patient Outcomes
Official title: Psychological Benefits and Potential Pathogen Transmission in Hospitalized Pediatric Oncology Patients Receiving Therapy Dog Visits: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pediatric Cancer, Animal-Assisted Activities
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: Seattle Children's Hospital
First posted: 2018-03-20
Enrollment: 26
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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:

1. To assess the effect of therapy dog visits on psychosocial outcomes and satisfaction with care among pediatric oncology inpatients.
2. 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.

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.

Primary outcomes:
measure: Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales (PedsQL VAS) total distress score
timeFrame: Immediately after first visit (Intention to Treat)
measure: Microbial load (colony forming units; cfu) on child hands
timeFrame: Immediately after first visit (Intention to Treat and Per Protocol)
Secondary outcomes:
measure: Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales (PedsQL VAS) total distress score
timeFrame: Immediately after first visit (Per Protocol)
measure: Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales (PedsQL VAS) individual scales (afraid/scared, sad/blue, angry, worry, tired, pain/hurt)
timeFrame: Immediately after first visit (Intention to Treat)
measure: Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales (PedsQL VAS) emotional distress summary score.
timeFrame: Immediately after first visit (Intention to Treat)
measure: Presence of Clinically Important Organisms
timeFrame: Immediately after first visit (Intention to Treat and Per Protocol)
measure: Pediatric Quality of Life Inventory (PedsQL) Cancer Module: treatment anxiety dimension
timeFrame: Hospital discharge (hospital discharge date varies by patient), 3 days post-hospital discharge, and 9-weeks post-hospital discharge, (Intention to Treat)
measure: Patient feelings when thinking about being in the hospital (afraid/scared, sad/blue, angry; worried)
timeFrame: Hospital discharge (hospital discharge date varies by patient), 3 days post-hospital discharge, and 9-weeks post-hospital discharge), (Intention to Treat)
measure: The Positive and Negative Affect Schedule (PANAS): parent measure of child's positive affect
timeFrame: Primary: Hospital discharge (hospital discharge date varies by patient); secondary: 3 days post-hospital discharge and 9-weeks post-hospital discharge (Intention to Treat)
measure: The Positive and Negative Affect Schedule (PANAS): parent measure of child's negative affect
timeFrame: Primary: Hospital discharge (hospital discharge date varies by patient); secondary: 3 days post-hospital discharge and 9-weeks post-hospital discharge (Intention to Treat)
measure: Six-item short-form of the state scale of the Spielberger State-Trait Anxiety Inventory (STAI)
timeFrame: Immediately after first visit, (Intention to Treat)
measure: Parent rating of hospital
timeFrame: Primary: Hospital discharge (hospital discharge date varies by patient); secondary: 3 days post-hospital discharge and 9-weeks post-hospital discharge (Intention to Treat)
measure: Microbial load (colony forming units; cfu) on hands that touched the dog versus hands of medically eligible controls
timeFrame: Immediately after first visit
Other outcomes:
measure: Change in microbial load (colony forming units; cfu) on hands that touched the dog
timeFrame: Immediately before and immediately after first visit
measure: Infections
timeFrame: From enrollment through 1-month post-completion of participation (participation = up to 4-weeks post-enrollment).
measure: Change in Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales (PedsQL VAS) total score among patients receiving a therapy dog visit
timeFrame: Immediately before and immediately after first visit
measure: Change in Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales (PedsQL VAS) emotional distress summary score among patients receiving a therapy dog visit
timeFrame: Immediately before and immediately after first visit
measure: Change in Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales (PedsQL VAS) individual scales (afraid/scared, sad/blue, angry, worry, tired, pain/hurt) among patients receiving a therapy dog visit
timeFrame: Immediately before and immediately after first visit
measure: Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales (PedsQL VAS) total score stratified by age
timeFrame: Immediately after first visit, (Intention to Treat), Stratified by Age
measure: Pediatric Quality of Life Inventory (PedsQL) Cancer Module
timeFrame: Hospital discharge (hospital discharge date varies by patient, 3 days post-hospital discharge, and 9-weeks post-hospital discharge), (Intention to Treat)
Locations:
city: Seattle
country: United States
facility: Kaiser Permanente Washington Health Research Institute
state: Washington
city: Seattle
country: United States
facility: Kaiser Permanente Washington Health Research Institute
state: Washington
Study officials:
References: