Horse-assisted Interventions in an Oncological Centre
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 4
- 主要终点
- Change in Functional Assessment of Cancer Therapy-General (FACT-G) total score
研究概览
简要总结
This study is a non-pharmacological, controlled, randomized interventional study with two arms: standard onco-hematology therapy compared with standard therapy associated with the Equine-Assisted Therapy (EAT).
详细描述
Animal therapeutic role has been recognized since the origin of Medicine: Hippocrates suggested horse riding against insomnia and for body and spirit recovery. In the last ten years pet therapy has been considerably extended and in 2015 the Italian Ministry of Health developed national guidelines to standardize operational protocols, in order to achieve a proper and uniform application of Animal-Assisted Interventions (AAI), to guarantee patient and animal safety.
At present, several studies have demonstrated that Horse-Assisted Intervention (HAI), compared to other types of pet therapy, has physical activity as added value, because it contributes to endorphins, serotonin and noradrenaline production, which are beneficial to a person's state of mind.
Furthermore, due to horse's corporeality, rhythms and needs, between patient and horse a complex bivalent relationship is established, thus developing self-confidence and self-esteem. In spite of the number of AAIs existing on a national basis, the majority of them lacks a solid methodological structure and they are based on the descriptive analysis of results, rather than on hypothesis, objectives and on quantitative evaluations.
The ISACCO study is a non-pharmacological, controlled, randomized interventional study with two arms: standard onco-hematology therapy compared with standard therapy associated with the Horse-Assisted Intervention (HAI). Aim of this project is to evaluate the improvement of the quality of life and the effectiveness of Horse-Assisted Intervention (HAI) on physiological characteristics, on symptoms control and on psychoemotional aspects, producing a recovery of self-esteem and of normal social function in people with cancer. This project has as its primary objective the improvement of the quality of life of adolescent-young adult patients (16-39 years) affected by onco-hematological neoplasia and of women with breast cancer (aged 18-65).
A secondary objective is to evaluate the intervention's effectiveness regarding physiological parameters (BMI, blood chemistry tests), symptom control, and psycho-emotional well-being (improvement in anxiety and depressive states), facilitated by the anticipated recovery of self-esteem and normal social functioning among individuals affected by cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescents-Young adults (16 - 39 years old) of both sexes with onco-hematological cancer at any stage who have completed chemotherapy and/or radiotherapy at least 3 months before enrolment
- •Women (18 - 65 years) with breast cancer who have completed chemotherapy and/or radiotherapy at least 3 months before enrolment
- •ECOG PS 0-1
- •Written informed consent
- •Subjects who don't practice any other equestrian sport
- •Life expectancy greater than 6 months
- •Subjects who are able to understand the study and cooperate according to study procedures, based on Investigator's opinion.
排除标准
- •Horse Allergy
- •Critical Bone lesions
- •Moderate to severe neutropenia
- •Moderate to severe Thrombocytopenia
- •ECOG PS>2
- •Uncontrolled epilepsy
研究组 & 干预措施
Arm A
Standard Clinical practice. Participants receive usual clinical care only. They undergo the same clinical evaluations, blood sampling, and quality-of-life assessments at baseline, 3 months, and 6 months as the experimental group.
Arm B
Clinical practice + Horse Assisted Intervention (HAI). Participants receive usual clinical care plus Horse Assisted Intervention (HAI) consisting of one supervised 45-minute session per week for 6 months, delivered by a multidisciplinary team.
干预措施: Horse-Assisted Intervention (HAI) (Behavioral)
结局指标
主要结局
Change in Functional Assessment of Cancer Therapy-General (FACT-G) total score
时间窗: Baseline and 6 months
Change in health-related quality of life measured using the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire. The FACT-G is a 27-item questionnaire with a total score ranging from 0 to 108, where higher scores indicate better quality of life.
次要结局
- Change in Body Mass Index (BMI)(Baseline, 3 months, and 6 months)
- Change in Edmonton Symptom Assessment System (ESAS) total score(Baseline, 3 months, and 6 months)
- Change in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 15 Palliative (EORTC QLQ-C15-PAL) scores(Baseline, 3 months, and 6 months)
- Change in Profile of Mood States (POMS) Total Mood Disturbance score(Baseline, 3 months, and 6 months)
- Change in Hospital Anxiety and Depression Scale (HADS) anxiety score(Baseline, 3 months, and 6 months)
- Change in hematobiochemical parameters(Baseline, 3 months, and 6 months)
- Change in depressive symptoms assessed by the Beck Depression Inventory-II (BDI-II)(Baseline, 3 months, and 6 months)