Rehabilitation Through Hippotherapy for the Management of Women After Primary Treatment of Breast Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Breast Cancer - Female
- Physical Disability
- Psychological Distress
- Side Effects
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: A randomized simple-blind controlled trial on efficacy of the hippotherapy treatment against conventional one will be conducted. Patients selected will be randomly divided into 2 groups: hippotherapy treated group versus control group. To ensure that patients in the 2 groups are similar in all respects, except for the planned intervention, the randomization will be stratified by age (18- 44, 45-55, ?56) representing respectively three stages: 1) Pre-menopause; 2) Peri-menopause; 3) Post-menopause; and by type of treatment: A) Single treatment: surgery or chemotherapy or hormone therapy or radiotherapy; B) Two or more treatments.Masking: Single (Investigator)Masking Description: Data will be collected on the Montpellier Institut du Sein site by relying on the CRA who will follow up and check the information in due time of the self-questionnaires. The data will be duly anonymized and handled blindly. Data will be centralized on a secure server at the Equiphoria Institute. Their processing and analysis will be carried out blindly by the PI or by a private service provider (Biostatem France)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 80 years
- Gender
- Only males
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. Hippo...
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.
Tracking Information
- NCT #
- NCT04350398
- Collaborators
- Institut Equiphoria - La Canourgue, France
- Montpellier Institut du Sein - Montpellier, France
- Clinique Clementville - Montpellier, France
- Kle?sia Languedoc Service de l'Action Sociale - France
- Fondation Cre?dit Agricole Solidarite? et De?veloppement - France
- Crédit Agricole du Languedoc - France
- Investigators
- Study Director: Manuel Gaviria, MD, PhD Alliance Equiphoria
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