Evaluation of the Efficacy of a Physical Therapy-yoga-patient Educational Program for Breast Cancer Patients With Pain Due to Hormonal Therapy Treatment.
NCT ID: NCT04457895
Last Updated: 2026-02-05
Study Results
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Basic Information
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RECRUITING
NA
108 participants
INTERVENTIONAL
2021-02-11
2028-08-31
Brief Summary
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Additional medicines (acupuncture, hypnosis, yoga) have become more and more popular these last years. 48 to 80% of patients with BC eventually choose them. A review comparing efficacy of various therapies to decrease osteoarticular pain concludes to a highest efficacy of anti-inflammatory treatments, paracetamol and yoga.
It thus appears innovative to complete this care with a patient educational project (PEP) in postural yoga instructed by a trained physical therapist, which will enable patients to practice yoga postures at home by themselves.
The investigators conducted a pilot study "SKYPE" with 24 algic patients treated with HT after BC, whose results are very promising.
The investigators now propose in the continuity of the pilot study a multicenter randomized controlled study comparing the efficacy of SKYPE care on pain reduction, an educative care combining physical therapy and yoga, to a control group in patients treated with HT for a BC with osteoarticular and/or musculoskeletal pain.
Furthermore, in order to examine whether yoga interventions may influence inflammation through their effects on the level of a wide range of pro- and anti-inflammatory cytokines (30), the investigators will Change in circulating cytokines' level between baseline level (T0) and post-treatment level (T2) in both groups will be analyzed and if so correlation will be established.
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Detailed Description
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Yoga has shown a real benefit in terms of pain reduction in patients with BC treated with HT. These osteoarticular pains are the secondary effect on which a physical therapeutic care can have a real benefit.
It thus appears innovative to complete this care with a therapeutic education program (TEP) in postural yoga which will enable patients to practice yoga postures at home by themselves. Yoga allows a large adaptation to pains expressed by each patient. It will favor the development of the feeling of control that they have in particular on their pain. participants will so improve the self-efficacy, the quality of life, and will reduce their fatigue and their pain. The patients involved have already lived major body transformations because of the disease and treatments. Yoga will help them put their lives together again, both physically and psychologically, and reclaim their body.
Studies have shown the short-term effects of yoga practice on anxiety, stress, pain and quality of life. Few rare studies have suggested that patients could add yoga practice at home to the supervised sessions, but these studies lacked therapeutic patient education. To date, to our knowledge, no data on the effect of the realization of yoga postures at home on increase of the patients' self-competency feeling are available in France. Also, the long-term effects of such programs need to be assessed.
The Montpellier Cancer Institute (ICM) has set-up 8 years ago yoga sessions for women with breast cancer, together with an association located in Montpellier.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Experimental arm
For experimental arm patients, there will be a 90-min yoga-therapeutic education session/week (during 6 weeks) given by a physical therapist trained to postural yoga (the first on site and by videoconference for the others).
Starting the first day of the yoga practice there will be one daily 15 min session at home with "My Yoga Guide" and the audio guide during 12 weeks.
educational yoga program
Daily 15-min yoga sessions at home with the "Le guide du yoga" and the audio-guide, during 12 weeks.
One 90-min yoga-therapeutic education session/week (during 6 weeks) given by a physical therapist trained to postural yog (the first on site and by videoconference for the others)
control arm
The control arm patients will have standard care. They will be proposed to participate in the physical therapy - yoga - educational program after the end of the study.
no intervention
no yoga session at home and no yoga -therapeutic educatuion session
Interventions
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educational yoga program
Daily 15-min yoga sessions at home with the "Le guide du yoga" and the audio-guide, during 12 weeks.
One 90-min yoga-therapeutic education session/week (during 6 weeks) given by a physical therapist trained to postural yog (the first on site and by videoconference for the others)
no intervention
no yoga session at home and no yoga -therapeutic educatuion session
Eligibility Criteria
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Inclusion Criteria
* Non metastatic breast cancer
* Ongoing hormone therapy, with no treatment modification in the 30 days before inclusion
* Osteoarticular and/or musculoskeletal pain due to HT ≥ 4 on the Numeric Pain Rating Scale (NPRS)
* Previous treatment (surgery, chemotherapy or radiotherapy) ended at least 2 months before inclusion
* Informed patient and signed informed consent received
* Affiliation to a social security system
Exclusion Criteria
* Regular Yoga practice in the 3 months before inclusion
* Contraindication or clinical state not allowing physical practice
* Patient whose regular follow-up is initially impossible for psychological, family, social or geographical reasons,
* Pregnant and breastfeeding woman
18 Years
99 Years
FEMALE
No
Sponsors
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Institut du Cancer de Montpellier - Val d'Aurelle
OTHER
Responsible Party
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Principal Investigators
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Kerstin Faravel
Role: STUDY_CHAIR
ICM Val d'Aurelle
Locations
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CH Libourne
Libourne, Aquitaine, France
Icm Val D'Aurelle
Montpellier, Herault, France
CHU Nîmes
Nîmes, Herault, France
Insitut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, Meurthe-et-Moselle,, France
Institut Bergonié
Bordeaux, Nouvelle-Aquitaine, France
Institut du sein Basque
Tosse, Nouvelle-Aquitaine, France
Institut de Cancérologie de l'Ouest
Angers, Pays de la Loire Region, France
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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PROICM 2020-05 SKY
Identifier Type: -
Identifier Source: org_study_id
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