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Breast CancerISACCONCT07831460

Horse-assisted Interventions in an Oncological Centre

A study testing Horse-Assisted Intervention (HAI) in people with Breast Cancer and Oncologic Disorders, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 4 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 16 to 65 years
What is being tested?
Horse-Assisted Intervention (HAI)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
4 sitesItaly
Study dates
14 Jun 2021to 31 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

4 sites in 1 country.

Italy4 sites

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST IRCCS

    Meldola, FC, 47014

  • Santa Maria delle Croci Hospital Hematology Department, AUSL Romagna

    Ravenna, RA, 48121

  • Infermi Hospital Hematology Department, AUSL Romagna

    Rimini, 47923

  • Infermi Hospital Onco - Hematology Pediatric Department

    Rimini, 47923

Other trials in Italy

About this study

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).

Read the detailed description

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

Being tested
Horse-Assisted Intervention (HAI)
Keywords
Horse Assisted Intervention (HAI), Animal-assisted interventions (AAI)
Medical subject headings
Breast Neoplasms, Hematologic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Horse-Assisted Intervention (HAI)Behavioural

    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.

Study groups in NCT07831460
Study groupRoleWhat they receive
Arm ANo interventionStandard 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 BExperimentalClinical 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.
Receives: Behavioral: Horse-Assisted Intervention (HAI)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and 6 months

Secondary outcomes (7)

  1. Change in Body Mass Index (BMI)

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

    Measured: Baseline, 3 months, and 6 months

  2. 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.

    Measured: Baseline, 3 months, and 6 months

  3. 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.

    Measured: Baseline, 3 months, and 6 months

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

    Change in mood measured using the Profile of Mood States (POMS). The POMS questionnaire measures six different dimensions of mood swings over a period of time. These include: Tension or Anxiety, Anger or Hostility, Vigor or Activity, Fatigue or Inertia, Depression or Dejection, Confusion or Bewilderment. The test requires the subject to indicate for each word or statement how he or she has been feeling during the previous week. A five-point scale ranging from "not at all" to "extremely" is administered by experimenters to patients to assess their mood states.

    Measured: Baseline, 3 months, and 6 months

  5. 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.

    Measured: Baseline, 3 months, and 6 months

  6. 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.

    Measured: Baseline, 3 months, and 6 months

  7. 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.

    Measured: Baseline, 3 months, and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2026
  2. Study start14 Jun 2021
  3. Primary completion8 Aug 2024
  4. Study completion31 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07831460
Sponsor's protocol ID
IRST100.43
Acronym
ISACCO
Status last verified
Sep 2026
First submitted
9 Sep 2026
Last updated
1 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Horse-Assisted Intervention (HAI) in people with Breast Cancer and Oncologic Disorders, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 4 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Functional Assessment of Cancer Therapy-General (FACT-G) total score (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07831460.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.

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