Skip to main content
OpenTrials
Completed

NCT Number: NCT07831460

Horse-assisted Interventions in an Oncological Centre

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST IRCCS, Meldola, FC, Italy

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Horse Allergy
  • Critical Bone lesions
  • Moderate to severe neutropenia
  • Moderate to severe Thrombocytopenia
  • ECOG PS>2
  • Uncontrolled epilepsy

Treatment and study plan

Horse-Assisted Intervention (HAI)

Behavioral

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.

Primary outcomes

  1. Change in Functional Assessment of Cancer Therapy-General (FACT-G) total score

    Time frame: 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.

Secondary outcomes

  1. Change in Body Mass Index (BMI)

    Time frame: Baseline, 3 months, and 6 months

    Change in body mass index (BMI), calculated from body weight and height. BMI is reported in kg/m².

  2. Change in Edmonton Symptom Assessment System (ESAS) total score

    Time frame: Baseline, 3 months, and 6 months

    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.

  3. Change in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 15 Palliative (EORTC QLQ-C15-PAL) scores

    Time frame: Baseline, 3 months, and 6 months

    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.

  4. Change in Profile of Mood States (POMS) Total Mood Disturbance score

    Time frame: Baseline, 3 months, and 6 months

    Change in mood measured using the Profile of Mood States (POMS). Higher Total Mood Disturbance scores indicate worse mood disturbance.

  5. Change in Hospital Anxiety and Depression Scale (HADS) anxiety score

    Time frame: Baseline, 3 months, and 6 months

    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.

  6. Change in hematobiochemical parameters

    Time frame: Baseline, 3 months, and 6 months

    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.

  7. Change in depressive symptoms assessed by the Beck Depression Inventory-II (BDI-II)

    Time frame: Baseline, 3 months, and 6 months

    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.

Sponsors and collaborators

Lead sponsor

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

Other

Registry information

Acronym: ISACCO

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Sep 21, 2026
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.