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

Primary Purpose

Breast Cancer Female, Side Effects, Psychological Distress

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Hippotherapy
Conventional therapy
Sponsored by
Alliance Equiphoria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer Female focused on measuring Breast cancer, Hippotherapy, Global rehabilitation, Quality of life, Body image, Cognitive impairment, Fatigue, Anxiety and depression, Physical impairment, Psychological reinforcement, Social reintegration

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Institut Equiphoria

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Hippotherapy treated group

Conventional therapy treated group

Arm Description

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.).

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.

Outcomes

Primary Outcome Measures

Change in Quality of life through EORTC QLQ-C30
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.

Secondary Outcome Measures

Changes in Body image representation through Body Image Scale (BIS)
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)
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)
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)
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.

Full Information

First Posted
April 10, 2020
Last Updated
September 30, 2022
Sponsor
Alliance Equiphoria
Collaborators
Institut Equiphoria - La Canourgue, France, Montpellier Institut du Sein - Montpellier, France, Clinique Clementville - Montpellier, France, Klésia Languedoc Service de l'Action Sociale - France, Fondation Crédit Agricole Solidarité et Développement - France, Crédit Agricole du Languedoc - France
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1. Study Identification

Unique Protocol Identification Number
NCT04350398
Brief Title
Rehabilitation Through Hippotherapy for the Management of Women After Primary Treatment of Breast Cancer
Acronym
HippoBreastCa
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
April 20, 2017 (Actual)
Primary Completion Date
August 30, 2022 (Actual)
Study Completion Date
August 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alliance Equiphoria
Collaborators
Institut Equiphoria - La Canourgue, France, Montpellier Institut du Sein - Montpellier, France, Clinique Clementville - Montpellier, France, Klésia Languedoc Service de l'Action Sociale - France, Fondation Crédit Agricole Solidarité et Développement - France, Crédit Agricole du Languedoc - France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Female, Side Effects, Psychological Distress, Physical Disability
Keywords
Breast cancer, Hippotherapy, Global rehabilitation, Quality of life, Body image, Cognitive impairment, Fatigue, Anxiety and depression, Physical impairment, Psychological reinforcement, Social reintegration

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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 representing respectively two stages: 1) Pre-menopause; 2) Post-menopause; and by type of treatment: A) Single treatment: surgery or chemotherapy or hormone therapy or radiotherapy; B) Two or more treatments.
Masking
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)
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hippotherapy treated group
Arm Type
Experimental
Arm Description
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.).
Arm Title
Conventional therapy treated group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Hippotherapy
Intervention Description
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
Intervention Name(s)
Conventional therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Quality of life through EORTC QLQ-C30
Description
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.
Time Frame
Before the beginning of the protocol; after the first 1-week session; at the end of the last session at 6 months
Secondary Outcome Measure Information:
Title
Changes in Body image representation through Body Image Scale (BIS)
Description
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.
Time Frame
Before the beginning of the protocol; after the first 1-week session; at the end of the last session at 6 months
Title
Changes in Fatigue sensation through Multidimensional Fatigue Inventory (MFI-20)
Description
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.
Time Frame
Before the beginning of the protocol; after the first 1-week session; at the end of the last session at 6 months
Title
Changes in anxiety and depression through Hospital Anxiety and Depression Scale (HADS)
Description
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.
Time Frame
Before the beginning of the protocol; after the first 1-week session; at the end of the last session at 6 months
Title
Changes in the Cognitive sphere assessment through Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog)
Description
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.
Time Frame
Before the beginning of the protocol; after the first 1-week session; at the end of the last session at 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manuel Gaviria, MD, PhD
Organizational Affiliation
Alliance Equiphoria
Official's Role
Study Director
Facility Information:
Facility Name
Institut Equiphoria
City
La Canourgue
ZIP/Postal Code
48500
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Dissemination of study results will be done through a classic strategy for publications (reports, scientific publications) and communications (congresses, meetings). The coordinator will be in charge of the dissemination strategy. Controlled access to the final trial dataset will be given when a reasonable request has a precise and valid scientific aim. Thus, we will protect the rights of patients and the intellectual property of the scientists who designed the trial and collected the data.
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Rehabilitation Through Hippotherapy for the Management of Women After Primary Treatment of Breast Cancer

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