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

NCT04350398 | Completed DMC

• 1 other identifier: 2016-A01656-45
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Before the beginning of the protocol; after the first 1-week session; at the end of the last session at 6 months

Secondary Outcomes (4)

• 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 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 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

Study Arms (2)

Hippotherapy treated group

EXPERIMENTAL

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.).

Other: Hippotherapy

Conventional therapy treated group

PLACEBO COMPARATOR

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

Interventions

Hippotherapy 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.

Hippotherapy treated group

Conventional therapy 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.

Conventional therapy treated group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alliance Equiphoria: lead
• Institut Equiphoria - La Canourgue, France: collaborator
• Montpellier Institut du Sein - Montpellier, France: collaborator
• Clinique Clementville - Montpellier, France: collaborator
• Klésia Languedoc Service de l'Action Sociale - France: collaborator
• Fondation Crédit Agricole Solidarité et Développement - France: collaborator
• Crédit Agricole du Languedoc - France: collaborator

Study Sites (1)

Institut Equiphoria

La Canourgue, 48500, France

Location

Related Publications (36)

• Khan F, Amatya B, Ng L, Demetrios M, Zhang NY, Turner-Stokes L. Multidisciplinary rehabilitation for follow-up of women treated for breast cancer. Cochrane Database Syst Rev. 2012 Dec 12;12(12):CD009553. doi: 10.1002/14651858.CD009553.pub2.

  PMID: 23235677 BACKGROUND

• Hulka BS, Moorman PG. Breast cancer: hormones and other risk factors. Maturitas. 2001 Feb 28;38(1):103-13; discussion 113-6. doi: 10.1016/s0378-5122(00)00196-1.

  PMID: 11311599 BACKGROUND

• Belot A, Grosclaude P, Bossard N, Jougla E, Benhamou E, Delafosse P, Guizard AV, Molinie F, Danzon A, Bara S, Bouvier AM, Tretarre B, Binder-Foucard F, Colonna M, Daubisse L, Hedelin G, Launoy G, Le Stang N, Maynadie M, Monnereau A, Troussard X, Faivre J, Collignon A, Janoray I, Arveux P, Buemi A, Raverdy N, Schvartz C, Bovet M, Cherie-Challine L, Esteve J, Remontet L, Velten M. Cancer incidence and mortality in France over the period 1980-2005. Rev Epidemiol Sante Publique. 2008 Jun;56(3):159-175. doi: 10.1016/j.respe.2008.03.117. Epub 2008 Jun 10.

  PMID: 18547762 BACKGROUND

• Klein D, Mercier M, Abeilard E, Puyraveau M, Danzon A, Dalstein V, Pozet A, Guizard AV, Henry-Amar M, Velten M. Long-term quality of life after breast cancer: a French registry-based controlled study. Breast Cancer Res Treat. 2011 Aug;129(1):125-34. doi: 10.1007/s10549-011-1408-3. Epub 2011 Feb 22.

  PMID: 21340477 BACKGROUND

• Miaskowski C, Dibble SL. The problem of pain in outpatients with breast cancer. Oncol Nurs Forum. 1995 Jun;22(5):791-7.

  PMID: 7675686 BACKGROUND

• Hopwood P, Haviland JS, Sumo G, Mills J, Bliss JM, Yarnold JR; START Trial Management Group. Comparison of patient-reported breast, arm, and shoulder symptoms and body image after radiotherapy for early breast cancer: 5-year follow-up in the randomised Standardisation of Breast Radiotherapy (START) trials. Lancet Oncol. 2010 Mar;11(3):231-40. doi: 10.1016/S1470-2045(09)70382-1. Epub 2010 Feb 6.

  PMID: 20138809 BACKGROUND

• Lauridsen MC, Christiansen P, Hessov I. The effect of physiotherapy on shoulder function in patients surgically treated for breast cancer: a randomized study. Acta Oncol. 2005;44(5):449-57. doi: 10.1080/02841860510029905.

  PMID: 16118078 BACKGROUND

• Howard-Anderson J, Ganz PA, Bower JE, Stanton AL. Quality of life, fertility concerns, and behavioral health outcomes in younger breast cancer survivors: a systematic review. J Natl Cancer Inst. 2012 Mar 7;104(5):386-405. doi: 10.1093/jnci/djr541. Epub 2012 Jan 23.

  PMID: 22271773 BACKGROUND

• Demark-Wahnefried W, Winer EP, Rimer BK. Why women gain weight with adjuvant chemotherapy for breast cancer. J Clin Oncol. 1993 Jul;11(7):1418-29. doi: 10.1200/JCO.1993.11.7.1418.

  PMID: 8315439 BACKGROUND

• Lee JJ, Swain SM. Peripheral neuropathy induced by microtubule-stabilizing agents. J Clin Oncol. 2006 Apr 1;24(10):1633-42. doi: 10.1200/JCO.2005.04.0543.

  PMID: 16575015 BACKGROUND

• Burgess C, Cornelius V, Love S, Graham J, Richards M, Ramirez A. Depression and anxiety in women with early breast cancer: five year observational cohort study. BMJ. 2005 Mar 26;330(7493):702. doi: 10.1136/bmj.38343.670868.D3. Epub 2005 Feb 4.

  PMID: 15695497 BACKGROUND

• Christensen S, Zachariae R, Jensen AB, Vaeth M, Moller S, Ravnsbaek J, von der Maase H. Prevalence and risk of depressive symptoms 3-4 months post-surgery in a nationwide cohort study of Danish women treated for early stage breast-cancer. Breast Cancer Res Treat. 2009 Jan;113(2):339-55. doi: 10.1007/s10549-008-9920-9. Epub 2008 Feb 16.

  PMID: 18278553 BACKGROUND

• Galiano-Castillo N, Ariza-Garcia A, Cantarero-Villanueva I, Fernandez-Lao C, Diaz-Rodriguez L, Arroyo-Morales M. Depressed mood in breast cancer survivors: associations with physical activity, cancer-related fatigue, quality of life, and fitness level. Eur J Oncol Nurs. 2014 Apr;18(2):206-10. doi: 10.1016/j.ejon.2013.10.008. Epub 2013 Nov 5.

  PMID: 24201014 BACKGROUND

• Mehnert A, Berg P, Henrich G, Herschbach P. Fear of cancer progression and cancer-related intrusive cognitions in breast cancer survivors. Psychooncology. 2009 Dec;18(12):1273-80. doi: 10.1002/pon.1481.

  PMID: 19267364 BACKGROUND

• van Dam FS, Schagen SB, Muller MJ, Boogerd W, vd Wall E, Droogleever Fortuyn ME, Rodenhuis S. Impairment of cognitive function in women receiving adjuvant treatment for high-risk breast cancer: high-dose versus standard-dose chemotherapy. J Natl Cancer Inst. 1998 Feb 4;90(3):210-8. doi: 10.1093/jnci/90.3.210.

  PMID: 9462678 BACKGROUND

• Schagen SB, Muller MJ, Boogerd W, Rosenbrand RM, van Rhijn D, Rodenhuis S, van Dam FS. Late effects of adjuvant chemotherapy on cognitive function: a follow-up study in breast cancer patients. Ann Oncol. 2002 Sep;13(9):1387-97. doi: 10.1093/annonc/mdf241.

  PMID: 12196364 BACKGROUND

• Fan HG, Houede-Tchen N, Yi QL, Chemerynsky I, Downie FP, Sabate K, Tannock IF. Fatigue, menopausal symptoms, and cognitive function in women after adjuvant chemotherapy for breast cancer: 1- and 2-year follow-up of a prospective controlled study. J Clin Oncol. 2005 Nov 1;23(31):8025-32. doi: 10.1200/JCO.2005.01.6550.

  PMID: 16258100 BACKGROUND

• Myers JS. Chemotherapy-related cognitive impairment: the breast cancer experience. Oncol Nurs Forum. 2012 Jan;39(1):E31-40. doi: 10.1188/12.ONF.E31-E40.

  PMID: 22201666 BACKGROUND

• Reid-Arndt SA, Hsieh C, Perry MC. Neuropsychological functioning and quality of life during the first year after completing chemotherapy for breast cancer. Psychooncology. 2010 May;19(5):535-44. doi: 10.1002/pon.1581.

  PMID: 19472296 BACKGROUND

• Gokal K, Munir F, Wallis D, Ahmed S, Boiangiu I, Kancherla K. Can physical activity help to maintain cognitive functioning and psychosocial well-being among breast cancer patients treated with chemotherapy? A randomised controlled trial: study protocol. BMC Public Health. 2015 Apr 23;15:414. doi: 10.1186/s12889-015-1751-0.

  PMID: 25903195 BACKGROUND

• Bloom JR, Stewart SL, Chang S, Banks PJ. Then and now: quality of life of young breast cancer survivors. Psychooncology. 2004 Mar;13(3):147-60. doi: 10.1002/pon.794.

  PMID: 15022150 BACKGROUND

• Gilbert E, Ussher JM, Perz J. Sexuality after breast cancer: a review. Maturitas. 2010 Aug;66(4):397-407. doi: 10.1016/j.maturitas.2010.03.027. Epub 2010 May 2.

  PMID: 20439140 BACKGROUND

• Hoving JL, Broekhuizen ML, Frings-Dresen MH. Return to work of breast cancer survivors: a systematic review of intervention studies. BMC Cancer. 2009 Apr 21;9:117. doi: 10.1186/1471-2407-9-117.

  PMID: 19383123 BACKGROUND

• Islam T, Dahlui M, Majid HA, Nahar AM, Mohd Taib NA, Su TT; MyBCC study group. Factors associated with return to work of breast cancer survivors: a systematic review. BMC Public Health. 2014;14 Suppl 3(Suppl 3):S8. doi: 10.1186/1471-2458-14-S3-S8. Epub 2014 Nov 24.

  PMID: 25437351 BACKGROUND

• Ganz PA, Rowland JH, Desmond K, Meyerowitz BE, Wyatt GE. Life after breast cancer: understanding women's health-related quality of life and sexual functioning. J Clin Oncol. 1998 Feb;16(2):501-14. doi: 10.1200/JCO.1998.16.2.501.

  PMID: 9469334 BACKGROUND

• Tiggemann M. Body image across the adult life span: stability and change. Body Image. 2004 Jan;1(1):29-41. doi: 10.1016/S1740-1445(03)00002-0.

  PMID: 18089139 BACKGROUND

• Baucom DH, Porter LS, Kirby JS, Gremore TM, Keefe FJ. Psychosocial issues confronting young women with breast cancer. Breast Dis. 2005-2006;23:103-13. doi: 10.3233/bd-2006-23114.

  PMID: 16823173 BACKGROUND

• Rooney M, Wald A. Interventions for the management of weight and body composition changes in women with breast cancer. Clin J Oncol Nurs. 2007 Feb;11(1):41-52. doi: 10.1188/07.CJON.41-52.

  PMID: 17441396 BACKGROUND

• Perry S, Kowalski TL, Chang CH. Quality of life assessment in women with breast cancer: benefits, acceptability and utilization. Health Qual Life Outcomes. 2007 May 2;5:24. doi: 10.1186/1477-7525-5-24.

  PMID: 17474993 BACKGROUND

• Masini A. Equine-assisted psychotherapy in clinical practice. J Psychosoc Nurs Ment Health Serv. 2010 Oct;48(10):30-4. doi: 10.3928/02793695-20100831-08. Epub 2010 Sep 22.

  PMID: 20873699 BACKGROUND

• Cerulli C, Minganti C, De Santis C, Tranchita E, Quaranta F, Parisi A. Therapeutic horseback riding in breast cancer survivors: a pilot study. J Altern Complement Med. 2014 Aug;20(8):623-9. doi: 10.1089/acm.2014.0061. Epub 2014 Jun 25.

  PMID: 24963599 BACKGROUND

• Costa DS, Aaronson NK, Fayers PM, Pallant JF, Velikova G, King MT. Testing the measurement invariance of the EORTC QLQ-C30 across primary cancer sites using multi-group confirmatory factor analysis. Qual Life Res. 2015 Jan;24(1):125-33. doi: 10.1007/s11136-014-0799-0. Epub 2014 Sep 6.

  PMID: 25193618 BACKGROUND

• Joly F, Lange M, Rigal O, Correia H, Giffard B, Beaumont JL, Clisant S, Wagner L. French version of the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) version 3. Support Care Cancer. 2012 Dec;20(12):3297-305. doi: 10.1007/s00520-012-1439-2. Epub 2012 May 2.

  PMID: 22549504 BACKGROUND

• Smets EM, Garssen B, Cull A, de Haes JC. Application of the multidimensional fatigue inventory (MFI-20) in cancer patients receiving radiotherapy. Br J Cancer. 1996 Jan;73(2):241-5. doi: 10.1038/bjc.1996.42.

  PMID: 8546913 BACKGROUND

• Hopwood P, Fletcher I, Lee A, Al Ghazal S. A body image scale for use with cancer patients. Eur J Cancer. 2001 Jan;37(2):189-97. doi: 10.1016/s0959-8049(00)00353-1.

  PMID: 11166145 BACKGROUND

• Viruega H, Galy C, Loriette C, Jacquot S, Houpeau JL, Gaviria M. Breast Cancer: How Hippotherapy Bridges the Gap between Healing and Recovery-A Randomized Controlled Clinical Trial. Cancers (Basel). 2023 Feb 19;15(4):1317. doi: 10.3390/cancers15041317.

  PMID: 36831658 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Cognitive Dysfunction; Fatigue; Anxiety Disorders; Depression

Interventions

Equine-Assisted Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Animal Assisted Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Manuel Gaviria, MD, PhD

  Alliance Equiphoria

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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)
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 10, 2020
• First Posted: April 17, 2020
• Study Start: April 20, 2017
• Primary Completion: August 30, 2022
• Study Completion: August 30, 2022
• Last Updated: October 3, 2022

Record last verified: 2022-09

Locations

FR (1)