Advanced Cancer, Refractory Cancer, Relapsed Cancer
Conditions
Brief summary
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.
Detailed description
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 identify and document necessary modifications for a safe and feasible intervention * To obtain recruitment estimates and determine potential recruitment barriers * To evaluate elements of implementation fidelity (design, training, delivery/receipt of treatment, enactment) * To verify safety * To determine the preliminary efficacy of human-animal interaction sessions: * On children with a life threatening cancer for the outcomes of qualify of life, anxiety, depression, worry, and pain * On caregivers of children with a life threatening cancer for the outcomes of stress and anxiety Exploratory Objective: \- To explore mechanisms (reduced salivary cortisol and urinary norepinephrine levels) associated with 8 weeks of human-animal interaction.
Interventions
BEHAVIORALAnimal-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.
Sponsors
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Vanderbilt-Ingram Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Child: * Children age 6-17 years old that have been diagnosed with advanced cancer as defined by any stage of relapsed, recurrent or refractory cancer * Able to understand English or Spanish to complete consents and surveys Parent or Guardian: * Parent or guardian as determined by person who brings child to \>50% of their clinic visits * Able to understand English or Spanish to complete consents and surveys
Exclusion criteria
for both Children and Parent/Guardian: * Self-reported fear of or allergies to canines * Cognitive impairment as identified by healthcare team or inability to complete consenting process
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pediatric Quality of Life | Up to 2 months | 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. |
| Anxiety | Up to 2 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 31 |
| 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. | 43 |
| Total | 74 |
Baseline characteristics
| Characteristic | Animal-Assisted Interaction - Caregiver Participants | Total | Animal-Assisted Interaction - Child Participants |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 31 Participants | 31 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 43 Participants | 43 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants | 10 Participants | 1 Participants |
| Race (NIH/OMB) White | 30 Participants | 55 Participants | 25 Participants |
| Region of Enrollment United States | 43 participants | 74 participants | 31 participants |
| Sex: Female, Male Female | 28 Participants | 41 Participants | 13 Participants |
| Sex: Female, Male Male | 15 Participants | 33 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 74 |
| other Total, other adverse events | 0 / 74 |
| serious Total, serious adverse events | 0 / 74 |
Outcome results
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.
Time frame: Up to 2 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Animal-Assisted Interaction - Child Participants (Baseline) | Anxiety | 31.4 units on a scale | Standard Deviation 5.2 |
| Animal-Assisted Interaction - Child Participants (Week 4) | Anxiety | 29.2 units on a scale | Standard Deviation 4.5 |
| Animal-Assisted Interaction - Child Participants (Week 8) | Anxiety | 29.5 units on a scale | Standard Deviation 5.8 |
| Animal-Assisted Interaction - Caregiver Participants (Baseline) | Anxiety | 40.2 units on a scale | Standard Deviation 11.9 |
| Animal-Assisted Interaction - Caregiver Participants (Week 4) | Anxiety | 35.6 units on a scale | Standard Deviation 10.9 |
| Animal-Assisted Interaction - Caregiver Participants (Week 8) | Anxiety | 35.9 units on a scale | Standard Deviation 11.2 |
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.
Time frame: Up to 2 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Animal-Assisted Interaction - Child Participants (Baseline) | Pediatric Quality of Life | PedsQL (Physical) | 47.6 score on a scale | Standard Deviation 18.1 |
| Animal-Assisted Interaction - Child Participants (Baseline) | Pediatric Quality of Life | PedsQL (Emotional) | 65.6 score on a scale | Standard Deviation 20.6 |
| Animal-Assisted Interaction - Child Participants (Baseline) | Pediatric Quality of Life | PedsQL (Social) | 72.5 score on a scale | Standard Deviation 21.6 |
| Animal-Assisted Interaction - Child Participants (Baseline) | Pediatric Quality of Life | PedsQL (School) | 48.0 score on a scale | Standard Deviation 22.4 |
| Animal-Assisted Interaction - Child Participants (Baseline) | Pediatric Quality of Life | PedsQL (Psycho-Social) | 64.1 score on a scale | Standard Deviation 17.5 |
| Animal-Assisted Interaction - Child Participants (Baseline) | Pediatric Quality of Life | PedsQL (Overall) | 55.7 score on a scale | Standard Deviation 14.7 |
| Animal-Assisted Interaction - Child Participants (Week 4) | Pediatric Quality of Life | PedsQL (Emotional) | 65.7 score on a scale | Standard Deviation 19 |
| Animal-Assisted Interaction - Child Participants (Week 4) | Pediatric Quality of Life | PedsQL (School) | 50.0 score on a scale | Standard Deviation 21.3 |
| Animal-Assisted Interaction - Child Participants (Week 4) | Pediatric Quality of Life | PedsQL (Overall) | 56.9 score on a scale | Standard Deviation 18.2 |
| Animal-Assisted Interaction - Child Participants (Week 4) | Pediatric Quality of Life | PedsQL (Physical) | 50.3 score on a scale | Standard Deviation 23.5 |
| Animal-Assisted Interaction - Child Participants (Week 4) | Pediatric Quality of Life | PedsQL (Social) | 66.7 score on a scale | Standard Deviation 23.1 |
| Animal-Assisted Interaction - Child Participants (Week 4) | Pediatric Quality of Life | PedsQL (Psycho-Social) | 64.9 score on a scale | Standard Deviation 18.6 |
| Animal-Assisted Interaction - Child Participants (Week 8) | Pediatric Quality of Life | PedsQL (Overall) | 64.7 score on a scale | Standard Deviation 19.5 |
| Animal-Assisted Interaction - Child Participants (Week 8) | Pediatric Quality of Life | PedsQL (Psycho-Social) | 69.6 score on a scale | Standard Deviation 20 |
| Animal-Assisted Interaction - Child Participants (Week 8) | Pediatric Quality of Life | PedsQL (School) | 56.7 score on a scale | Standard Deviation 25.4 |
| Animal-Assisted Interaction - Child Participants (Week 8) | Pediatric Quality of Life | PedsQL (Social) | 66.7 score on a scale | Standard Deviation 25.1 |
| Animal-Assisted Interaction - Child Participants (Week 8) | Pediatric Quality of Life | PedsQL (Physical) | 61.6 score on a scale | Standard Deviation 27.7 |
| Animal-Assisted Interaction - Child Participants (Week 8) | Pediatric Quality of Life | PedsQL (Emotional) | 71.3 score on a scale | Standard Deviation 20.1 |
| Animal-Assisted Interaction - Caregiver Participants (Baseline) | Pediatric Quality of Life | PedsQL (School) | 46.4 score on a scale | Standard Deviation 19.2 |
| Animal-Assisted Interaction - Caregiver Participants (Baseline) | Pediatric Quality of Life | PedsQL (Emotional) | 51.9 score on a scale | Standard Deviation 16.1 |
| Animal-Assisted Interaction - Caregiver Participants (Baseline) | Pediatric Quality of Life | PedsQL (Social) | 63.8 score on a scale | Standard Deviation 20.5 |
| Animal-Assisted Interaction - Caregiver Participants (Baseline) | Pediatric Quality of Life | PedsQL (Overall) | 47.1 score on a scale | Standard Deviation 15.9 |
| Animal-Assisted Interaction - Caregiver Participants (Baseline) | Pediatric Quality of Life | PedsQL (Psycho-Social) | 52.3 score on a scale | Standard Deviation 16 |
| Animal-Assisted Interaction - Caregiver Participants (Baseline) | Pediatric Quality of Life | PedsQL (Physical) | 41.5 score on a scale | Standard Deviation 24.1 |
| Animal-Assisted Interaction - Caregiver Participants (Week 4) | Pediatric Quality of Life | PedsQL (Physical) | 37.8 score on a scale | Standard Deviation 18.8 |
| Animal-Assisted Interaction - Caregiver Participants (Week 4) | Pediatric Quality of Life | PedsQL (Psycho-Social) | 54.4 score on a scale | Standard Deviation 17 |
| Animal-Assisted Interaction - Caregiver Participants (Week 4) | Pediatric Quality of Life | PedsQL (Emotional) | 53.8 score on a scale | Standard Deviation 18.4 |
| Animal-Assisted Interaction - Caregiver Participants (Week 4) | Pediatric Quality of Life | PedsQL (Social) | 61.4 score on a scale | Standard Deviation 17.8 |
| Animal-Assisted Interaction - Caregiver Participants (Week 4) | Pediatric Quality of Life | PedsQL (School) | 50.5 score on a scale | Standard Deviation 23.4 |
| Animal-Assisted Interaction - Caregiver Participants (Week 4) | Pediatric Quality of Life | PedsQL (Overall) | 47.5 score on a scale | Standard Deviation 16 |
| Animal-Assisted Interaction - Caregiver Participants (Week 8) | Pediatric Quality of Life | PedsQL (School) | 58.8 score on a scale | Standard Deviation 21.8 |
| Animal-Assisted Interaction - Caregiver Participants (Week 8) | Pediatric Quality of Life | PedsQL (Social) | 62.9 score on a scale | Standard Deviation 20.7 |
| Animal-Assisted Interaction - Caregiver Participants (Week 8) | Pediatric Quality of Life | PedsQL (Psycho-Social) | 60.5 score on a scale | Standard Deviation 13.9 |
| Animal-Assisted Interaction - Caregiver Participants (Week 8) | Pediatric Quality of Life | PedsQL (Overall) | 55.0 score on a scale | Standard Deviation 15.1 |
| Animal-Assisted Interaction - Caregiver Participants (Week 8) | Pediatric Quality of Life | PedsQL (Emotional) | 58.8 score on a scale | Standard Deviation 15.1 |
| Animal-Assisted Interaction - Caregiver Participants (Week 8) | Pediatric Quality of Life | PedsQL (Physical) | 47.8 score on a scale | Standard Deviation 24.7 |