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| ID | Type | Description | Link |
|---|---|---|---|
| R21HD097757-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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This study will evaluate the effects of human-animal interaction on reducing anxiety, depression, worry, and pain and enhancing quality of life in children ages 6-17 years old with a life threatening cancer and their parent caregivers.
Objectives:
To examine the feasibility of human-animal interaction (HAI) sessions for children with a life threatening cancer and a primary caregiver, specifically to:
To determine the preliminary efficacy of human-animal interaction sessions:
Exploratory Objective:
- To explore mechanisms (reduced salivary cortisol and urinary norepinephrine levels) associated with 8 weeks of human-animal interaction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Animal-Assisted Interaction | Experimental | Children and their caregivers will spend approximately 10-15 minutes with a registered canine and its owner during potentially anxiety-producing visits to the clinic or hospital. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Animal-Assisted Interactions | Behavioral | Child and caregivers will spend approximately 10-5 minutes with a registered canine and its owner during potentially anxiety-producing visits to the clinic or hospital. |
| Measure | Description | Time Frame |
|---|---|---|
| Pediatric Quality of Life | The Pediatric Quality of Life Inventory (PedsQL) was administered to children and their parents (proxy for child quality of life) at baseline, week 4, and week 8 visits. Weeks 4 and 8 were after interacting with a therapy dog. Baseline surveys collected without seeing a therapy dog. The PedsQL Measurement is a validated scale to assess health-related quality of life in children and adolescents with acute and chronic health conditions. Scores are scaled from 1-100, with higher scores indicative of better quality of life. | Up to 2 months |
| Anxiety | The state-trait anxiety inventory State sub scale was administered to children (STAI-Child) and their parents (STAI) at baseline, week 4, and week 8. The 20-item STAI-CH is a validated scale for anxiety in children aged 5-17; the 20-item STAI is validated to assess anxiety in adult participants. The State subscale is intended to assess level of anxiety at the time of survey administration. Possible range of scores of the STAI-CH State subscale is 20-60, while the possible range from the STAI state subscale for adults is 20-80. Higher scores are indicative of increased anxiety. Baseline data were obtained without seeing a therapy dog, whereas STAI-CH and STAI surveys were conducted after seeing the therapy dog at weeks 4 and 8. | Up to 2 months |
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Inclusion Criteria:
Child:
Parent or Guardian:
Exclusion Criteria for both Children and Parent/Guardian:
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| Name | Affiliation | Role |
|---|---|---|
| Maryjo Gilmer, PhD | Vanderbilt Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Monroe Carell Jr Children's Hospital at Vanderbilt | Nashville | Tennessee | 37232 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Animal-Assisted Interaction -- Child Participants | Children will spend approximately 10-15 minutes with a registered canine and its owner during potentially anxiety-producing visits to the clinic or hospital. Animal-Assisted Interactions: Child will spend approximately 10-15 minutes with a registered canine and its owner during potentially anxiety-producing visits to the clinic or hospital. |
| FG001 | Animal-Assisted Interaction -- Adult Participants | Caregivers will spend approximately 10-15 minutes with a registered canine and its owner during potentially anxiety-producing visits to the clinic or hospital. Animal-Assisted Interactions: Caregivers will spend approximately 10-15 minutes with a registered canine and its owner during potentially anxiety-producing visits to the clinic or hospital. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Children ages 6-17 years with advanced cancer and their parents were enrolled in the study. Measures of stress, anxiety, and quality of life were collected at baseline.
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| ID | Title | Description |
|---|---|---|
| BG000 | Animal-Assisted Interaction - Child Participants | Children will spend approximately 10-15 minutes with a registered canine and its owner during potentially anxiety-producing visits to the clinic or hospital. Animal-Assisted Interactions: Child will spend approximately 10-5 minutes with a registered canine and its owner during potentially anxiety-producing visits to the clinic or hospital. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | The Pediatric Quality of Life Inventory (PedsQL) was administered to children and their parents (proxy for child quality of life) at baseline, week 4, and week 8 visits. Weeks 4 and 8 were after interacting with a therapy dog. Baseline surveys collected without seeing a therapy dog. The PedsQL Measurement is a validated scale to assess health-related quality of life in children and adolescents with acute and chronic health conditions. Scores are scaled from 1-100, with higher scores indicative of better quality of life. | Children ages 6-17 with relapsed or refractory cancer and their caregivers who participated in therapy dog visits for up to 8 weeks at clinic visits or in the hospital. | Posted | Mean | Standard Deviation | score on a scale | Up to 2 months |
|
Adverse event data was collected throughout the time frame each participant was assessed in relation to baseline which was a duration of up to 8 weeks.
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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 | Animal-Assisted Interaction | Children and their caregivers will spend approximately 10-15 minutes with a registered canine and its owner during potentially anxiety-producing visits to the clinic or hospital. Animal-Assisted Interactions: Child and caregivers will spend approximately 10-5 minutes with a registered canine and its owner during potentially anxiety-producing visits to the clinic or hospital. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mary Jo Gilmer | Vanderbilt School of Nursing | 6153430938 | maryjo.gilmer@vanderbilt.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 18, 2019 | Mar 12, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 18, 2021 | Feb 14, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| BG001 | Animal-Assisted Interaction - Caregiver Participants | Caregivers will spend approximately 10-15 minutes with a registered canine and its owner during potentially anxiety-producing visits to the clinic or hospital. Animal-Assisted Interactions: Caregivers will spend approximately 10-5 minutes with a registered canine and its owner during potentially anxiety-producing visits to the clinic or hospital. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG001 | Animal-Assisted Interaction - Child Participants (Week 4) | Child will spend approximately 10-15 minutes with a registered canine and its owner during potentially anxiety-producing visits to the clinic or hospital for up to 8 weeks. Week 4 data PedsQL survey conducted after seeing therapy dog. |
| OG002 | Animal-Assisted Interaction - Child Participants (Week 8) | Child will spend approximately 10-15 minutes with a registered canine and its owner during potentially anxiety-producing visits to the clinic or hospital for up to 8 weeks. Week 8 data PedsQL survey conducted after seeing therapy dog. |
| OG003 | Animal-Assisted Interaction - Caregiver Participants (Baseline) | Caregivers will spend approximately 10-5 minutes with a registered canine and its owner during potentially anxiety-producing visits to the clinic or hospital. Caregiver-Proxy data on child quality of life obtained using PedsQL survey. Baseline data obtained without seeing therapy dog. |
| OG004 | Animal-Assisted Interaction - Caregiver Participants (Week 4) | Caregivers will spend approximately 10-5 minutes with a registered canine and its owner during potentially anxiety-producing visits to the clinic or hospital. Caregiver-Proxy data on child quality of life obtained using PedsQL survey. Week 4 data obtained after seeing therapy dog. |
| OG005 | Animal-Assisted Interaction - Caregiver Participants (Week 8) | Caregivers will spend approximately 10-5 minutes with a registered canine and its owner during potentially anxiety-producing visits to the clinic or hospital. Caregiver-Proxy data on child quality of life obtained using PedsQL survey. Week 8 data obtained after seeing therapy dog. |
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|
| Primary | Anxiety | The state-trait anxiety inventory State sub scale was administered to children (STAI-Child) and their parents (STAI) at baseline, week 4, and week 8. The 20-item STAI-CH is a validated scale for anxiety in children aged 5-17; the 20-item STAI is validated to assess anxiety in adult participants. The State subscale is intended to assess level of anxiety at the time of survey administration. Possible range of scores of the STAI-CH State subscale is 20-60, while the possible range from the STAI state subscale for adults is 20-80. Higher scores are indicative of increased anxiety. Baseline data were obtained without seeing a therapy dog, whereas STAI-CH and STAI surveys were conducted after seeing the therapy dog at weeks 4 and 8. | Posted | Mean | Standard Deviation | units on a scale | Up to 2 months |
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| 0 |
| 74 |
| 0 |
| 74 |
| 0 |
| 74 |
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