Rehabilitation Through Hippotherapy for the Management of Women After Primary Treatment of Breast Cancer (HippoBreastCa)
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|ClinicalTrials.gov Identifier: NCT04350398|
Recruitment Status : Recruiting
First Posted : April 17, 2020
Last Update Posted : April 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Female Side Effects Psychological Distress Physical Disability||Other: Hippotherapy Other: Conventional therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||86 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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 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|
|Official Title:||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|
|Actual Study Start Date :||April 20, 2017|
|Estimated Primary Completion Date :||November 30, 2021|
|Estimated Study Completion Date :||February 15, 2022|
Experimental: 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.).
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.
Placebo Comparator: 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.
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.
- Change in Quality of life through EORTC QLQ-C30 [ Time Frame: 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.
- Changes in Body image representation through Body Image Scale (BIS) [ Time Frame: Before the beginning of the protocol; after the first 1-week session; at the end of the last session at 6 months ]The questionnaire focuses on patients' emotional and behavioral experiences of their body image, resulting from cancer and treatment, including aspects of perceived physical appearance, body integrity, and seduction capacity. The total score ranges from 0 to 30. A higher score means a higher level of body image disturbance.
- Changes in Fatigue sensation through Multidimensional Fatigue Inventory (MFI-20) [ Time Frame: Before the beginning of the protocol; after the first 1-week session; at the end of the last session at 6 months ]MFI seems to be one of the best questionnaires to provide a fatigue profile. Its psychometric properties have been studied in different populations and it is easy to administer. Score ranges from 0 to 100. Higher total scores correspond with more acute levels of fatigue.
- Changes in anxiety and depression through Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Before the beginning of the protocol; after the first 1-week session; at the end of the last session at 6 months ]This scale was constructed excluding any item concerning somatic aspects, aspects that could be confused between physical and mental illness. It is a self-questionnaire to be completed according to oneself condition during the past week. Score ranges from 0 to 21 for each item. Higher total scores correspond to presence of the respective state.
- Changes in the Cognitive sphere assessment through Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) [ Time Frame: Before the beginning of the protocol; after the first 1-week session; at the end of the last session at 6 months ]The questions are grouped into six cognitive domains (memory, verbal fluency, concentration, mental sharpness, resistance to interference, multitasking ability) and two sub-criteria (visibility of the disorder by the entourage, impact on the quality of life). 37-item ranging from 0 to 4 consist of four subscales. Higher scores represent better functioning.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04350398
|Contact: Manuel Gaviria, MD, PhDemail@example.com|
|Contact: Corinne Galy, MDfirstname.lastname@example.org|
|La Canourgue, France, 48500|
|Contact: Manuel Gaviria, MD, PhD +33466321046 email@example.com|
|Contact: Hélène Viruega, ESMHL +33466321046 firstname.lastname@example.org|
|Principal Investigator: Corinne Galy, MD|
|Sub-Investigator: Huei Yune Bonnin-Koang, MD|
|Sub-Investigator: Olivier Maille, MD|
|Sub-Investigator: Emilie Monrigal, MD|
|Study Director:||Manuel Gaviria, MD, PhD||Alliance Equiphoria|