Rehabilitation Through Hippotherapy for the Management of Women After Primary Treatment of Breast Cancer

NCT ID: NCT04350398

Last Updated: 2022-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-20
• Study Completion Date: 2022-08-30

Brief Summary

Breast cancer is the most common women's cancer and the third leading cause of death. Advances in prevention, detection and primary treatment have improved overall survival leading to its growing acceptance as a long-term disease. Following the announcement of breast cancer, but also after primary treatment, some symptoms appear directly compromising psychic and physical spheres. Hippotherapy is an emerging specialized rehabilitation approach performed through specially trained horses by accredited health professionals. The proposed hippotherapy program offers key elements for physical, psychic and social reinforcement, complementing conventional care. The aim is to provide patients with tools to consolidate their self-awareness and thus strengthen their ability to cope with the disease.

Detailed Description

Following the announcement and evolution of breast cancer, but also in response to primary treatment, some symptoms appear to directly compromise the psychic and/or physical sphere of the individual. Current rehabilitation programs are not sufficiently oriented to solve most of these symptoms. Hippotherapy is an emerging specialized rehabilitation approach, performed on a specially trained horse by accredited health professionals (e.g. medical doctors, physical therapists, occupational therapists, psychomotricians, speech-language pathologists, clinical psychologists). The horse is an excellent collaborator in situations of physical and psychic disability, whether temporary or consolidated. It provides human support for impairments (anatomical or physiological), activity limitations, and participation restrictions as defined by WHO. Hippotherapy has a direct action on the sensorimotor capacities of the individual but also on his cognitive abilities, i.e. attention, memory, psychomotricity, emotion, perception, sequencing of complex movements, self-experience, psychic temporality. Overall, the strong solicitation of the sensory and motor spheres promotes and interacts with the mechanisms related to the execution of tasks in the cognitive domain through the interactions of several neural networks. A randomized simple-blinded controlled trial on hippotherapy versus conventional care will be carried out. After giving their informed consent, patients will be enrolled in the trial. The 6-months program includes 1-week daily sessions of hippotherapy by the end of the initial cancer treatment followed by three short 2-days sessions with an interval of 2 months between each. The study will focus on 86 patients. Recruitment will be done over a 48-months' period. A battery of self-administered questionnaires will allow to study both the functional and psychological outcome. The primary end point will be quality of life, whereas body image, fatigue, anxiety, depression and cognitive performances will be the secondary end points.

Conditions

Breast Cancer Female; Side Effects; Psychological Distress; Physical Disability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Hippotherapy treated group

During the initial week of intervention, sessions will be mainly carried on horseback. We will use the movement of the horse: (i) to allow patient re-appropriating her body and find harmony; (ii) to initiate rehabilitation of movements (shoulder, neck, upper extremity, whole body), gesture and femininity. The goal is to reconstruct a harmonic body image both in the private and public sphere, through different techniques. A few walking sessions may be needed to reinforce some landmarks.

During the short stages the work will be mainly done by walking alongside the horse. These reinforcement periods act like a trampoline, necessary to have a new momentum providing the opportunity to take a step back from the everyday, to regenerate somehow. The reaction time is generally optimized considering the imprint done during the initial long stage. One of the main themes that come up during this period is fear (relapse, the future, not achieving the goals, pain, relationship issues, etc.).

Group Type: EXPERIMENTAL

Hippotherapy

Intervention Type: OTHER

The horse is an excellent collaborator in situations of physical and mental disability, whether temporary or consolidated. It provides support to humans towards an impairment (anatomical or physiological), a disability, or a restriction of participation as defined by the WHO in 2001. Hippotherapy has a direct action on the sensorimotor capacities of the individual but also on their cognitive capacities, such as attention, memory, psychomotricity, emotions, perceptions, the sequencing of complex movements, or the experience of oneself and the functions of time. Overall, the strong demand from the sensitive, sensory and motor spheres promotes and interacts with the mechanisms linked to the execution of tasks in the cognitive domain (memory, attention, executive functions, speed of information processing, etc.) through the interactions of several neural networks.

Conventional therapy treated group

Patients in the control group are followed by dedicated personnel of the Montpellier Institut du Sein. This personalized care pathway after/during the cancer treatment takes into consideration all aspects of the disease, allowing to coordinate the intervention of the professionals that the patient might need in order to better preserve her quality of life while answering questions about cancer, prevention, treatments, or life after illness. The MIS mobilizes a chain of skills and support by providing patients: radiologists, pathologists, surgeons, oncologists, and radiation therapists, nuclear doctors, physiotherapists, cardiologists, psychologists, psychiatrists, nurses, social workers, nutritionists, dieticians, onco-geneticists, osteopaths, homeopaths, acupuncturists, sexologists, addictologists, algologists, and vascular physicians.

Group Type: PLACEBO_COMPARATOR

Conventional therapy

Intervention Type: OTHER

Personalized care pathway after/during the cancer treatment takes into consideration all aspects of the disease, allowing to coordinate the intervention of the professionals that the patient might need in order to better preserve her quality of life while answering questions about cancer, prevention, treatments, or life after illness. The MIS mobilizes a chain of skills and support by providing patients: radiologists, pathologists, surgeons, oncologists, and radiation therapists, nuclear doctors, physiotherapists, cardiologists, psychologists, psychiatrists, nurses, social workers, nutritionists, dieticians, onco-geneticists, osteopaths, homeopaths, acupuncturists, sexologists, addictologists, algologists, and vascular physicians.

Interventions

Hippotherapy

The horse is an excellent collaborator in situations of physical and mental disability, whether temporary or consolidated. It provides support to humans towards an impairment (anatomical or physiological), a disability, or a restriction of participation as defined by the WHO in 2001. Hippotherapy has a direct action on the sensorimotor capacities of the individual but also on their cognitive capacities, such as attention, memory, psychomotricity, emotions, perceptions, the sequencing of complex movements, or the experience of oneself and the functions of time. Overall, the strong demand from the sensitive, sensory and motor spheres promotes and interacts with the mechanisms linked to the execution of tasks in the cognitive domain (memory, attention, executive functions, speed of information processing, etc.) through the interactions of several neural networks.

Intervention Type: OTHER

Conventional therapy

Personalized care pathway after/during the cancer treatment takes into consideration all aspects of the disease, allowing to coordinate the intervention of the professionals that the patient might need in order to better preserve her quality of life while answering questions about cancer, prevention, treatments, or life after illness. The MIS mobilizes a chain of skills and support by providing patients: radiologists, pathologists, surgeons, oncologists, and radiation therapists, nuclear doctors, physiotherapists, cardiologists, psychologists, psychiatrists, nurses, social workers, nutritionists, dieticians, onco-geneticists, osteopaths, homeopaths, acupuncturists, sexologists, addictologists, algologists, and vascular physicians.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Confirmed histological diagnosis of breast cancer staging [T1-T3, N0-N2 and M0]
• Patient already scheduled or ongoing treatment for surgery and/or chemotherapy and/or hormone therapy and/or radiotherapy
• Having consulted a physician of the Care and Support Unit of the MIS during its health care
• WHO performance index from 0 to 2
• Able to give her informed consent in writing
• Able to complete questionnaires
• Abduction of the hip necessary and sufficient (to allow horse riding)
• Affiliated to a social security scheme
• Certificate of no contraindication issued by the physician in charge

Exclusion Criteria

• History of malignant tumors in the last 5 years with the exception of basocellular skin carcinoma or squamous cell carcinoma
• Breast cancer as a secondary diagnosis
• Medication intake or presence of conditions associated with fatigue (e.g. chronic fatigue syndrome)
• Concomitant and uncontrolled severe degenerative or chronic disease
• History of allergic reactions to dust and/or horsehair, or asthma
• Contraindications to physical activity
• History of horseback riding or hippotherapeutic treatment during the last 6 months
• Clinically significant cognitive impairment or dementia
• Pregnancy and breastfeeding
• Majors protected by law
• Patient participating in another biomedical research or in exclusion period

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Institut Equiphoria - La Canourgue, France

UNKNOWN

Sponsor Role: collaborator

Montpellier Institut du Sein - Montpellier, France

UNKNOWN

Sponsor Role: collaborator

Clinique Clementville - Montpellier, France

UNKNOWN

Sponsor Role: collaborator

Klésia Languedoc Service de l'Action Sociale - France

UNKNOWN

Sponsor Role: collaborator

Fondation Crédit Agricole Solidarité et Développement - France

UNKNOWN

Sponsor Role: collaborator

Crédit Agricole du Languedoc - France

UNKNOWN

Sponsor Role: collaborator

Alliance Equiphoria

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Manuel Gaviria, MD, PhD

Role: STUDY_DIRECTOR

Alliance Equiphoria

Locations

Institut Equiphoria

La Canourgue, , France

Countries

France

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Other Identifiers

2016-A01656-45

Identifier Type: -

Identifier Source: org_study_id