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).
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Horse-Assisted Intervention (HAI) is a therapeutic or educational approach that involves structured interactions between people and horses. It uses the horse's movement, physical presence, and relational characteristics to promote physical, emotional, cognitive, and social well-being.
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST IRCCS
Meldola, FC, Italy
Santa Maria delle Croci Hospital Hematology Department, AUSL Romagna
Ravenna, RA, Italy
Infermi Hospital Hematology Department, AUSL Romagna
Rimini, Italy
Infermi Hospital Onco - Hematology Pediatric Department
Rimini, Italy
Change in Functional Assessment of Cancer Therapy-General (FACT-G) total score
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.
Time frame: Baseline and 6 months
Change in Body Mass Index (BMI)
Change in body mass index (BMI), calculated from body weight and height. BMI is reported in kg/m².
Time frame: Baseline, 3 months, and 6 months
Change in Edmonton Symptom Assessment System (ESAS) total score
Change in symptom burden measured using the Edmonton Symptom Assessment System (ESAS). Total scores range from 0 to 90, with higher scores indicating worse symptom burden.
Time frame: 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
Change in quality of life measured using the EORTC QLQ-C15-PAL questionnaire. Scores range from 0 to 100. Higher functional scores indicate better functioning, whereas higher symptom scores indicate worse symptoms.
Time frame: Baseline, 3 months, and 6 months
Change in Profile of Mood States (POMS) Total Mood Disturbance score
Change in mood measured using the Profile of Mood States (POMS). Higher Total Mood Disturbance scores indicate worse mood disturbance.
Time frame: Baseline, 3 months, and 6 months
Change in Hospital Anxiety and Depression Scale (HADS) anxiety score
Change in anxiety symptoms measured using the Hospital Anxiety and Depression Scale (HADS). Scores range from 0 to 21, with higher scores indicating greater anxiety.
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Time frame: Baseline, 3 months, and 6 months
Change in hematobiochemical parameters
Change in hematobiochemical parameters measured from blood samples, including complete blood count, cortisol, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and blood glucose concentration.
Time frame: Baseline, 3 months, and 6 months
Change in depressive symptoms assessed by the Beck Depression Inventory-II (BDI-II)
Change in depressive symptom severity measured using the Beck Depression Inventory-II (BDI-II). Total scores range from 0 to 63; higher scores indicate more severe depressive symptoms.
Time frame: Baseline, 3 months, and 6 months