Advanced CancerNCT03765099
Animal-Assisted Interactions in 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 animal-assisted interactions (AAI) on stress, anxiety, and quality of life in children with a life-threatening condition and their parents. It is anticipated to be a milestone in understanding the human-animal bond. Read more about this study
- Who is it for?
- Ages 3 to 17 years
- 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
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2019to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children 3-17 years old
- Confirmed diagnosis of relapsed or refractory cancer
Who cannot join
- Reported fear or anxiety of dogs (child or parent)
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: Effects of Animal-Assisted Interactions (AAI) on Quality of Life in Children With Life-Threatening Conditions and Their Parents
This study will evaluate the effects of animal-assisted interactions (AAI) on stress, anxiety, and quality of life in children with a life-threatening condition and their parents. It is anticipated to be a milestone in understanding the human-animal bond.
Read the detailed description
Objectives:
- Examine the feasibility of animal-assisted interactions sessions for children with a life-threatening condition and primary caregiver to:
- Identify and document modifications for a safe and feasible intervention,
- Obtain recruitment estimates and determine potential recruitment barriers
- Evaluate elements of implementation fidelity (design, training, delivery/receipt of Treatment, enactment)
- Verify safety. H1-1: Children and parents (>60%) will complete the interventions and provide positive acceptability data. H1-2: Implementation fidelity can be achieved with the proposed methodology
- Determine the preliminary efficacy of animal-assisted interactions sessions for:
- Children with a life-threatening condition (LTC) for the outcome of health-related quality of life
- Children with a LTC and their primary caregivers for the outcomes of stress and anxiety
H2-1 Children with a life-threatening condition who receive animal-assisted interactions will experience improved health-related quality of life (HRQOL) more than patients who do not receive animal-assisted interactions.
H2-2a Children with life-threatening condition who receive animal-assisted interactions will experience decreased stress and anxiety more than parents of children who do not receive animal-assisted interactions.
H2-2b Primary caregivers of children with a life-threatening condition who receive animal-assisted interactions will experience decreased stress and anxiety more than parents of children who do not receive animal-assisted interactions.
- 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
Also called AAI
Child and caregivers randomly assigned to the intervention group will spend approximately 15 min with a registered canine and its owner during potentially anxiety-producing visits to the hospital.
| Study group | Role | What they receive |
|---|---|---|
| Animal-Assisted Interactions | Experimental | Children and their caregivers randomly assigned to the intervention group will spend approximately 15 min with a registered canine and its owner during potentially anxiety-producing visits to the hospital. Receives: Behavioral: Animal-Assisted Interactions |
| Usual Care | Active comparator | Children and their caregivers randomly assigned to the usual care group will receive usual care which may include play therapy, music therapy or visits with a social worker during their visits to the 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 Peds Quality of Life measure will be administered to children and their parents (proxy) once a month
Measured: up to 3 months
Anxiety
The state-trait anxiety inventory will be administered to children and their parents after each intervention or usual care visit
Measured: up to 3 months
Stress
Saliva samples to measure cortisol levels will be administered to children after animal-assisted interventions or after completion of measures in usual care group
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start21 Feb 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Human Animal Bond Research Institute
- 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
- NCT03765099
- Sponsor's protocol ID
- VICC PED 18166
- Status last verified
- Jan 2023
- First submitted
- 3 Dec 2018
- Last updated
- 23 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mahoney AB, Akard TF, Cowfer BA, Dietrich MS, Newton JL, Gilmer MJ. Impact of Animal-Assisted Interaction on Anxiety in Children With Advanced Cancer and Their Caregivers. J Palliat Med. 2024 Jan;27(1):75-82. doi: 10.1089/jpm.2023.0091. Epub 2023 Sep 25.
PubMed 37751186Cowfer BA, Akard TF, Gilmer MJ. Animal-Assisted Interventions for Children with Advanced Cancer: Child and Parent Perceptions. Palliat Med Rep. 2021 Nov 17;2(1):328-334. doi: 10.1089/pmr.2021.0039. eCollection 2021.
PubMed 34927159
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Animal-Assisted Interactions (AAI) on Quality of Life in Children With Life-Threatening Conditions and Their Parents
- ClinicalTrials.gov ID
- NCT03765099
- Acronym / sponsor ID
- VICC PED 18166
- Conditions
- Advanced Cancer, Relapsed Cancer, Refractory Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- Human Animal Bond Research Institute
- Study start
- 21 Feb 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 5 Dec 2018 (actual)
- Results
- Not posted in the source record
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 animal-assisted interactions (AAI) on stress, anxiety, and quality of life in children with a life-threatening condition and their parents. It is anticipated to be a milestone in understanding the human-animal bond.
Detailed description
Objectives:
- Examine the feasibility of animal-assisted interactions sessions for children with a life-threatening condition and primary caregiver to:
- Identify and document modifications for a safe and feasible intervention,
- Obtain recruitment estimates and determine potential recruitment barriers
- Evaluate elements of implementation fidelity (design, training, delivery/receipt of Treatment, enactment)
- Verify safety. H1-1: Children and parents (>60%) will complete the interventions and provide positive acceptability data. H1-2: Implementation fidelity can be achieved with the proposed methodology
- Determine the preliminary efficacy of animal-assisted interactions sessions for:
- Children with a life-threatening condition (LTC) for the outcome of health-related quality of life
- Children with a LTC and their primary caregivers for the outcomes of stress and anxiety
H2-1 Children with a life-threatening condition who receive animal-assisted interactions will experience improved health-related quality of life (HRQOL) more than patients who do not receive animal-assisted interactions.
H2-2a Children with life-threatening condition who receive animal-assisted interactions will experience decreased stress and anxiety more than parents of children who do not receive animal-assisted interactions.
H2-2b Primary caregivers of children with a life-threatening condition who receive animal-assisted interactions will experience decreased stress and anxiety more than parents of children who do not receive animal-assisted interactions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Animal-Assisted Interactions | Experimental | Behavioral: Animal-Assisted InteractionsChildren and their caregivers randomly assigned to the intervention group will spend approximately 15 min with a registered canine and its owner during potentially anxiety-producing visits to the hospital. |
| Usual Care | Active comparator | Behavioral: Animal-Assisted InteractionsChildren and their caregivers randomly assigned to the usual care group will receive usual care which may include play therapy, music therapy or visits with a social worker during their visits to the hospital. |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children 3-17 years old
- Confirmed diagnosis of relapsed or refractory cancer
Key exclusion criteria (1 listed)
- Reported fear or anxiety of dogs (child or parent)
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 InteractionsAlso: AAIChild and caregivers randomly assigned to the intervention group will spend approximately 15 min with a registered canine and its owner during potentially anxiety-producing visits to the hospital. | Behavioural | Animal-Assisted Interactions, Usual Care |
Primary outcome
Pediatric Quality of Life
Time frame: up to 3 months
The Peds Quality of Life measure will be administered to children and their parents (proxy) once a month
Anxiety
Time frame: up to 3 months
The state-trait anxiety inventory will be administered to children and their parents after each intervention or usual care visit
Stress
Time frame: up to 3 months
Saliva samples to measure cortisol levels will be administered to children after animal-assisted interventions or after completion of measures in usual care group
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2023.
- Derived from this study: PubMed 37751186Mahoney AB, Akard TF, Cowfer BA, Dietrich MS, Newton JL, Gilmer MJ. Impact of Animal-Assisted Interaction on Anxiety in Children With Advanced Cancer and Their Caregivers. J Palliat Med. 2024 Jan;27(1):75-82. doi: 10.1089/jpm.2023.0091. Epub 2023 Sep 25.
- Derived from this study: PubMed 34927159Cowfer BA, Akard TF, Gilmer MJ. Animal-Assisted Interventions for Children with Advanced Cancer: Child and Parent Perceptions. Palliat Med Rep. 2021 Nov 17;2(1):328-334. doi: 10.1089/pmr.2021.0039. eCollection 2021.
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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 2 inclusion and 1 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 23 Jan 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03765099, which also lists 2 linked publications.
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 23 Jan 2023.