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| Name | Class |
|---|---|
| Seattle Children's Hospital | OTHER |
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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Therapy Dog Visits | Experimental | 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. |
|
| Control Group | No Intervention | Participants randomized to the Control Group will receive usual medical care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapy Dog Visit | Behavioral | 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales (PedsQL VAS) Total Distress Score | The Pediatric Quality of Life Present Functioning Visual Analog Scale 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) |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Microbial Load (Colony Forming Units; Cfu) on Hands That Touched the Dog | Microbial load change from pre-visit to post-visit in the intervention group; only among participants who got a dog visit and only the hand(s) that touched the dog. | Immediately before and immediately after first visit |
| Infections |
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Washington Health Research Institute | Seattle | Washington | 98101 | United States | ||
| Kaiser Permanente Washington Health Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37930283 | Derived | Chubak J, Adler A, Bobb JF, Hawkes RJ, Ziebell RA, Pocobelli G, Ludman EJ, Zerr DM. A Randomized Controlled Trial of Animal-assisted Activities for Pediatric Oncology Patients: Psychosocial and Microbial Outcomes. J Pediatr Health Care. 2024 May-Jun;38(3):354-364. doi: 10.1016/j.pedhc.2023.09.010. Epub 2023 Nov 4. |
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Parent Participants are not counted as Enrolled in the Participant Flow numbers because only Child Participants are randomized and eligible to receive the Intervention. Parent Participants do not participate in any Intervention activities and only complete 1 data collection activity.
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| ID | Title | Description |
|---|---|---|
| FG000 | Therapy Dog Visits | 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. Therapy Dog Visit: 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:
|
| FG001 | Control Group | Participants randomized to the Control Group will receive usual medical care. |
| FG002 | Parents of Enrolled Children Randomized to Therapy Dog Visits | This group includes parents of children randomized to the Therapy Dog Visits Group who Enrolled to provide parent data for the STAI Measure |
| FG003 | Parents of Enrolled Children Randomized to the Control Group | This group includes parents of children randomized to the Control Group who Enrolled to provide parent data for the STAI Measure |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Randomized participants and their parents (note that the Enrolled Number is 26, as parents are not randomized or enrolled)
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| ID | Title | Description |
|---|---|---|
| BG000 | Therapy Dog Visits | 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. Therapy Dog Visit: 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:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Data on Age was only collected for Child Participants. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales (PedsQL VAS) Total Distress Score | The Pediatric Quality of Life Present Functioning Visual Analog Scale 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. | Two out of 14 patients randomized to the control arm did not have a visit 1; one out of 12 patients randomized to the intervention group did not complete the survey. | Posted | Mean | Standard Deviation | score on a scale | Immediately after first visit (Intention to Treat) |
|
58 days after randomization
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Therapy Dog Visits | 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. Therapy Dog Visit: 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:
|
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The study did not meet its recruitment target and may therefore have been underpowered
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessica Chubak | Kaiser Permanente | 206-287-2556 | jessica.chubak@kp.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 7, 2018 | Jul 12, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 24, 2022 | Jul 12, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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Outcomes Assessors include clinical research assistants and laboratory personnel. Laboratory personnel will be blinded. Clinical research assistants collecting surveys and specimens will not be blinded.
|
|
| 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) | Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales (PedsQL VAS). Each of 6 individual 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) |
| Number of Participants With the 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. Nineteen parents participated (9 from the intervention group and 10 from the control group). | 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 |
Counts of persons and Infections/Positive Cultures, including descriptions |
| From enrollment through 1-month post-completion of participation (participation = up to 4-weeks post-enrollment). |
| Change in Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales (PedsQL VAS) Total Score Among Patients Receiving a Therapy Dog Visit | Score change from pre-visit to post-visit. 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. Score changes can range from -100 to 100. Negative changes in scores indicate better outcomes. Intervention Group only and only participants who received a dog visit. | Immediately before and immediately after first visit |
| 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 | Score change from pre-visit to post-visit. 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. Score changes can range from -100 to 100. Negative changes in scores indicate better outcomes. Intervention Group only and only participants who received a dog visit. | Immediately before and immediately after first visit |
| 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 | Individual item change from pre-visit to post-visit. Each of 6 scales (afraid/scared, sad/blue, angry, worry, tired, pain/hurt) ranges from 0-100, with lower scores indicating a better outcome. Score changes can range from -100 to 100. Negative changes in scores indicate better outcomes. Intervention Group only and only participants who received a dog visit. | Immediately before and immediately after first visit |
| Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales (PedsQL VAS) Total Score Stratified by Age | 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), Stratified by Age |
| Pediatric Quality of Life Inventory (PedsQL) Cancer Module | The PedsQL Cancer Module measures quality of life in children and teens with cancer based on 8 dimensions (pain and hurt, nausea, procedural anxiety, treatment anxiety, worry, cognitive problems, perceived physical appearance, and communication). Items are reversed scored and linearly transformed on a 0-100 scale and then summed and divided by the number of items answered. Higher scores indicate better outcomes. | Hospital discharge (hospital discharge date varies by patient, 3 days post-hospital discharge, and 9-weeks post-hospital discharge), (Intention to Treat) |
| Seattle |
| Washington |
| 98126 |
| United States |
| BG001 | Control Group | Participants randomized to the Control Group will receive usual medical care. |
| BG002 | Parents of Enrolled Children Randomized to Therapy Dog Visits | This group includes parents of children randomized to the Therapy Dog Visits Group who Enrolled to provide parent data for the STAI Measure |
| BG003 | Parents of Enrolled Children Randomized to the Control Group | This group includes parents of children randomized to the Control Group who Enrolled to provide parent data for the STAI Measure |
| BG004 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Data on Race was only collected for Child Participants | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Data on Ethnicity was only collected for child participants. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| PedsQLTM Present Functioning Visual Analog Scales total score | Range = 0 to 100; Lower scores indicate better outcomes. | Data on the PedsQLTM Present Functioning Visual Analog Scales total score was only collected for Child Participants. | Mean | Standard Deviation | units on a scale |
|
| Total microbial load on left hand | Data on Total microbial load on left hand was only collected for Child Participants | Mean | Standard Deviation | CFU/mL on log 10 scale |
|
| Total microbial load on right hand | Data on Total microbial load on right hand was only collected on Child Participants. | Mean | Standard Deviation | CFU/mL on log10 scale |
|
| OG001 | Control Group | Participants randomized to the Control Group will receive usual medical care. |
|
|
|
| Primary | Microbial Load (Colony Forming Units; Cfu) on Child Hands | Microbial load on child hands | 12 intervention patients (24 hands) and 12 control patients (24 hands) [excluding 2 control patients who did not have a visit 1] | Posted | Mean | Standard Deviation | Colony Forming Units/mL on log10 scale | Immediately after first visit (Intention to Treat and Per Protocol) | Hands | Hands |
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| Secondary | 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. | Per protocol analyses are equivalent to intention-to-treat analyses since all intervention patients received a dog visit and none of the control group patients who had a first visit were medically ineligible for a dog visit. | Posted | Mean | Standard Deviation | units on a scale | Immediately after first visit (Per Protocol) |
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| Secondary | Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales (PedsQL VAS) Individual Scales (Afraid/Scared, Sad/Blue, Angry, Worry, Tired, Pain/Hurt) | Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales (PedsQL VAS). Each of 6 individual scales (afraid/scared, sad/blue, angry, worry, tired, pain/hurt) ranges from 0-100, with lower scores indicating a better outcome. | Two out of 14 patients randomized to the control arm did not have a visit 1; one out of 12 patients randomized to the intervention group did not complete the survey. | Posted | Mean | Standard Deviation | score on a scale | Immediately after first visit (Intention to Treat) |
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| Secondary | 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. | Two out of 14 patients randomized to the control arm did not have a visit 1; one out of 12 patients randomized to the intervention group did not complete the survey | Posted | Mean | Standard Deviation | units on a scale | Immediately after first visit (Intention to Treat) |
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| Secondary | Number of Participants With the 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 | excluding 2 control patients who did not have a visit 1 | Posted | Count of Participants | Participants | Immediately after first visit (Intention to Treat and Per Protocol) |
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| Secondary | 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. | Patients who completed the follow-up assessment at each time point. | Posted | Mean | Standard Deviation | score on a scale | Hospital discharge (hospital discharge date varies by patient), 3 days post-hospital discharge, and 9-weeks post-hospital discharge, (Intention to Treat) |
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| Secondary | 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. | Patients who completed the follow-up assessment at each time point | Posted | Count of Participants | Participants | Hospital discharge (hospital discharge date varies by patient), 3 days post-hospital discharge, and 9-weeks post-hospital discharge), (Intention to Treat) |
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| Secondary | 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. | Patients who completed the follow-up assessment at each time point | Posted | Mean | Standard Deviation | score on a scale | Primary: Hospital discharge (hospital discharge date varies by patient); secondary: 3 days post-hospital discharge and 9-weeks post-hospital discharge (Intention to Treat) |
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| Secondary | 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. | Patients who completed the follow-up assessment at each time point | Posted | Mean | Standard Deviation | score on a scale | Primary: Hospital discharge (hospital discharge date varies by patient); secondary: 3 days post-hospital discharge and 9-weeks post-hospital discharge (Intention to Treat) |
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| Secondary | 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. Nineteen parents participated (9 from the intervention group and 10 from the control group). | One out of 10 parents of patients randomized to the control group who consented to participate in the study did not complete the survey | Posted | Mean | Standard Deviation | score on a scale | Immediately after first visit, (Intention to Treat) |
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| Secondary | 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. | Parents who completed the follow-up assessment at each time point | Posted | Mean | Standard Deviation | score on a scale | Primary: Hospital discharge (hospital discharge date varies by patient); secondary: 3 days post-hospital discharge and 9-weeks post-hospital discharge (Intention to Treat) |
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| Secondary | 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 | Of the 24 hands of the 12 intervention patients who had a visit, 15 hands (from 10 patients) were included in this analysis; all 24 hands from 12 control group patients who had a visit were included. | Posted | Mean | Standard Deviation | log10 CFU/mL | Immediately after first visit | hands | hands |
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| Other Pre-specified | Change in Microbial Load (Colony Forming Units; Cfu) on Hands That Touched the Dog | Microbial load change from pre-visit to post-visit in the intervention group; only among participants who got a dog visit and only the hand(s) that touched the dog. | Not Posted | Immediately before and immediately after first visit | Participants |
| Other Pre-specified | Infections | Counts of persons and Infections/Positive Cultures, including descriptions | Posted | Count of Participants | Participants | From enrollment through 1-month post-completion of participation (participation = up to 4-weeks post-enrollment). |
|
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|
| Other Pre-specified | Change in Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales (PedsQL VAS) Total Score Among Patients Receiving a Therapy Dog Visit | Score change from pre-visit to post-visit. 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. Score changes can range from -100 to 100. Negative changes in scores indicate better outcomes. Intervention Group only and only participants who received a dog visit. | Not Posted | Immediately before and immediately after first visit | Participants |
| Other Pre-specified | 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 | Score change from pre-visit to post-visit. 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. Score changes can range from -100 to 100. Negative changes in scores indicate better outcomes. Intervention Group only and only participants who received a dog visit. | Not Posted | Immediately before and immediately after first visit | Participants |
| Other Pre-specified | 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 | Individual item change from pre-visit to post-visit. Each of 6 scales (afraid/scared, sad/blue, angry, worry, tired, pain/hurt) ranges from 0-100, with lower scores indicating a better outcome. Score changes can range from -100 to 100. Negative changes in scores indicate better outcomes. Intervention Group only and only participants who received a dog visit. | Not Posted | Immediately before and immediately after first visit | Participants |
| Other Pre-specified | Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales (PedsQL VAS) Total Score Stratified by Age | 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. | Analysis includes patients with a visit 1 who completed the survey | Posted | Mean | Standard Deviation | units on a scale | Immediately after first visit, (Intention to Treat), Stratified by Age |
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| Other Pre-specified | Pediatric Quality of Life Inventory (PedsQL) Cancer Module | The PedsQL Cancer Module measures quality of life in children and teens with cancer based on 8 dimensions (pain and hurt, nausea, procedural anxiety, treatment anxiety, worry, cognitive problems, perceived physical appearance, and communication). Items are reversed scored and linearly transformed on a 0-100 scale and then summed and divided by the number of items answered. Higher scores indicate better outcomes. | Patients who completed the follow-up assessment at each time point. | Posted | Mean | Standard Deviation | score on a scale | Hospital discharge (hospital discharge date varies by patient, 3 days post-hospital discharge, and 9-weeks post-hospital discharge), (Intention to Treat) |
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| 2 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Control Group | Participants randomized to the Control Group will receive usual medical care. | 0 | 14 | 0 | 14 | 0 | 14 |
Not provided
Not provided
| Male |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Unknown or Not Reported |
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| Anger (angry) |
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| Worry (worry) |
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| Fatigue (tired) |
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| Pain (pain/hurt) |
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| Mean Difference (Final Values) |
| -1.7 |
| 2-Sided |
| 95 |
| -7.9 |
| 4.5 |
| Superiority |
| Anger scale (range 0-100; lower scores indicate better outcomes) | Mean Difference (Final Values) | -3.2 | 2-Sided | 95 | -16.7 | 10.4 | Superiority |
| Worry scale (range 0-100; lower scores indicate better outcomes) | Mean Difference (Final Values) | -1.3 | 2-Sided | 95 | -14.5 | 11.8 | Superiority |
| Fatigue scale (range 0-100; lower scores indicate better outcomes) | Mean Difference (Final Values) | -5.6 | 2-Sided | 95 | -32.2 | 20.9 | Superiority |
| Pain scale (range 0-100; lower scores indicate better outcomes) | Median Difference (Final Values) | -8.0 | 2-Sided | 95 | -25.0 | 9.0 | Superiority |
| Malassezia |
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| Aspergillus |
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| Pasteurella |
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| Enterobacteriaceae |
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| Acinetobacter |
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| Pseudomonas aeruginosa |
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| Clostridium difficile |
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| 3 days post-hospital discharge |
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| 9-weeks post-hospital discharge |
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| A little _____ |
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| _____ (Experiences the emotion) |
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| Very _____ |
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| Anxiety - 3 days post-hospital discharge |
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| Anxiety - 9-weeks post-hospital discharge |
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| Sadness - Hospital discharge |
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| Sadness - 3 days post-hospital discharge |
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| Sadness - 9-weeks post-hospital discharge |
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| Anger - Hospital discharge |
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| Anger - 3 days post-hospital discharge |
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| Anger - 9-weeks post-hospital discharge |
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| Worry - Hospital discharge |
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| Worry - 3 days post-hospital discharge |
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| Worry - 9-weeks post-hospital discharge |
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| 3 days post-hospital discharge |
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| 9-weeks post-hospital discharge |
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| 3 days post-hospital discharge |
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| 9-weeks post-hospital discharge |
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| 3 days post-hospital discharge |
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| 9-weeks post-hospital discharge |
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| 2 infections |
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| 3 days post-hospital discharge |
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| 9-weeks post-hospital discharge |
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