CompletedNot Applicable

Helping Improve Pediatric Patient Outcomes

United States26 participantsStarted 2018-03-19

Plain-language summary

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: 1. To assess the effect of therapy dog visits on psychosocial outcomes and satisfaction with care among pediatric oncology inpatients. 2. To determine whether therapy dog visits increase microbial levels on children's hands. 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.

Who can participate

Age range

5 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales (PedsQL VAS) Total Distress Score

Timeframe: Immediately after first visit (Intention to Treat)

Microbial Load (Colony Forming Units; Cfu) on Child Hands

Timeframe: Immediately after first visit (Intention to Treat and Per Protocol)

Trial details

NCT IDNCT03471221

SponsorKaiser Permanente

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-02-29

Results submitted2023-09-14

View on ClinicalTrials.gov More Pediatric Cancer, Animal-Assisted Activities trials