Exploring the Impact of Human-Animal Interactions on Children With Life-Threatening Conditions and Their Parents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Pediatric Quality of Life
研究概览
简要总结
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.
详细描述
Objectives:
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To examine the feasibility of human-animal interaction (HAI) sessions for children with a life threatening cancer and a primary caregiver, specifically to:
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To identify and document necessary modifications for a safe and feasible intervention
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To obtain recruitment estimates and determine potential recruitment barriers
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To evaluate elements of implementation fidelity (design, training, delivery/receipt of treatment, enactment)
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To verify safety
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To determine the preliminary efficacy of human-animal interaction sessions:
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On children with a life threatening cancer for the outcomes of qualify of life, anxiety, depression, worry, and pain
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On caregivers of children with a life threatening cancer for the outcomes of stress and anxiety
Exploratory Objective:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
Pediatric Quality of Life
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Maryjo Gilmer
Principal Investigator
Vanderbilt-Ingram Cancer Center