Advanced CancerNCT04310345
Impact of Human-Animal Interactions on Children With Life-Threatening Conditions and Their Parents
A study testing Animal-Assisted Interactions in people with Advanced Cancer and Relapsed Cancer, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Advanced Cancer, Relapsed Cancer, Refractory Cancer
- What is being tested?
- Animal-Assisted Interactions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2021to 27 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Self-reported fear of or allergies to canines
- Cognitive impairment as identified by healthcare team or inability to complete consenting process
Trial locations and contacts
1 site in 1 country.
United States1 site
Monroe Carell Jr Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232
About this study
Official title: Exploring the Impact of Human-Animal Interactions on Children With Life-Threatening Conditions and Their Parents
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.
Read the 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.
- Conditions
- Advanced Cancer, Relapsed Cancer, Refractory Cancer
- Being tested
- Animal-Assisted Interactions
- Medical subject headings
- Recurrence, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Animal-Assisted InteractionsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Animal-Assisted Interactions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start31 Mar 2021
- Primary completion9 Feb 2024
- Study completion27 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Maryjo Gilmer, Vanderbilt-Ingram Cancer Center
- Investigators
- Maryjo Gilmer, PhD, Principal investigator, Vanderbilt Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04310345
- Sponsor's protocol ID
- VICC PED 2003
- Other IDs
- R21HD097757-01
- Status last verified
- Jul 2024
- First submitted
- 13 Mar 2020
- Last updated
- 19 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Impact of Human-Animal Interactions on Children With Life-Threatening Conditions and Their Parents
- ClinicalTrials.gov ID
- NCT04310345
- Acronym / sponsor ID
- VICC PED 2003
- Conditions
- Advanced Cancer, Relapsed Cancer, Refractory Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 31 Mar 2021 (actual)
- Primary completion
- 9 Feb 2024 (actual)
- Study completion
- 27 Jun 2024 (actual)
- First posted
- 17 Mar 2020 (actual)
- Results
- Posted 19 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Animal-Assisted Interaction | Experimental | Behavioral: Animal-Assisted InteractionsChildren 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. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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 as determined by person who brings child to >50% of their clinic visits
- Able to understand English or Spanish to complete consents and surveys
Key exclusion criteria (2 listed)
- Self-reported fear of or allergies to canines
- Cognitive impairment as identified by healthcare team or inability to complete consenting process
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Animal-Assisted InteractionsChild 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. | Behavioural | Animal-Assisted Interaction |
Primary outcome
Pediatric Quality of Life
Time frame: 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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maryjo Gilmer, PhD principal investigator
Vanderbilt Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Animal-Assisted Interactions in people with Advanced Cancer and Relapsed Cancer, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric Quality of Life (time frame: Up to 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024.