Effect of Multidisciplinary Management by Hippotherapy on the Quality of Life of Women With a Diagnosis of Breast Cancer: Randomized Controlled Clinical Trial on the Effectiveness of the Therapeutic Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 83
- 试验地点
- 2
- 主要终点
- Change in Quality of life through EORTC QLQ-C30
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
盲法说明
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)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in Quality of life through EORTC QLQ-C30
时间窗: Before the beginning of the protocol; after the first 1-week session; at the end of the last session at 6 months
This questionnaire was designed to be cancer specific, multidimensional in structure, suitable for self-administration (brief and easy to complete), and applicable in a wide range of cultural contexts. The scores ranges from 0 to 100, a higher score represents a higher ("better") level of functioning.
次要结局
- Changes in Fatigue sensation through Multidimensional Fatigue Inventory (MFI-20)(Before the beginning of the protocol; after the first 1-week session; at the end of the last session at 6 months)
- Changes in anxiety and depression through Hospital Anxiety and Depression Scale (HADS)(Before the beginning of the protocol; after the first 1-week session; at the end of the last session at 6 months)
- Changes in Body image representation through Body Image Scale (BIS)(Before the beginning of the protocol; after the first 1-week session; at the end of the last session at 6 months)
- Changes in the Cognitive sphere assessment through Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog)(Before the beginning of the protocol; after the first 1-week session; at the end of the last session at 6 months)