Evaluation of the Efficacy of a Physical Therapy-yoga-patient Educational Program for Breast Cancer Patients With Pain Due to Hormonal Therapy Treatment.

Study Overview
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Brief Summary
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As much as 50% of patients treated with hormonotherapy (HT) for breast cancer (BC) suffer from osteoarticular pain during treatment. Secondary effects have become a real issue because of their consequences on the patients' quality of life, but also on treatment efficacy and survival when they induce dose reduction or premature withdrawal of treatment. 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.

Detailed Description
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Numerous initiatives have started in France, often associative. It is essential to evaluate in a rigorous manner, these therapies before making them part of the patient's care pathway. 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.

Official Title
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A Randomized, Open-labelled, Controlled Trial Evaluating the Efficacy of a Physical Therapy-yoga-patient Educational Program for Breast Cancer Patients With Pain Due to Hormonal Therapy Treatment.

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: educational yoga program
* Other: no intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years 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: Chronic rhumatologic pain with specific care needed 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental arm<br>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. | Behavioral: educational yoga program<br>* 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)<br>|
| Placebo Comparator: control arm<br>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. | Other: no intervention<br>* no yoga session at home and no yoga -therapeutic educatuion session<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the efficacy of a combined intervention of physical therapy and yoga, including patient education with a control group for confirmed osteoarticular and/or musculoskeletal pain (≥4) due to hormone therapy in patients treated for breast cancer. | Rate of patients with a 2-point reduction on the Numeric Pain Rating Scale (NPRS) of osteoarticular and/or musculoskeletal pain due to hormonal therapy treatment between T0 (inclusion) and T2 (end of treatment). | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the evolution of osteoarticular and/or musculoskeletal pain characteristics related to hormone therapy | The evolution of osteoarticular and/or musculoskeletal pain characteristics will be described according to the questionnaire BPI- Brief Pain Inventory | 12 weeks | 
| the patient compliance at yoga-therapeutic education session and yoga self-practice | The patient attendance at yoga-therapeutic education session and yoga self-practice will be noted on the logbooks filled out by the patients. | 12 weeks | 
| the reasons for adhesion or non-adhesion to yoga self-practice | The reasons why patients practice or do not practice yoga at home will be noted on the logbooks filled out by the patient | 12 weeks | 
| To assess forward-flexion flexibility | Forward-flexion flexibility is defined by the distance between the fingertips and the floor. It will be measured with a ruler. | 12 weeks | 
| To assess respiratory capacity | Respiratory capacity will be measured with a spirometer (Forced Expiratory Volume in 1 second (FEV1) | 12 weeks | 
| the hormone therapy treatment and its compliance | Taking hormonotherapy treatments will be reported in a log-book by the patients | 12 weeks | 
| to assess quality of life by short form questionnaire | Quality of life will be measured by EORTC SF-36 questionnaire (European Organisation for Research and Treatment of Cancer, Short Form) | 12 weeks | 
| to assess quality of life by Quality of Life Questionnaire | Quality of life will be measured by EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire) | 12 weeks | 
| to assess quality of life by Quality of Life Questionnaire specify for Breast Cance | Quality of life will be measured by EORTC QLQ-BR23 questionnaires (European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire specify for Breast Cancer) | 12 weeks | 
| to assess fatigue | Fatigue will be measured by the Fatigue dimension of the EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire) questionnaire | 12 weeks | 
| anxiety and depression | Anxiety and depression will be measured by HADS scale (Hospital Anxiety and Depression Scale) (if score or = 9, result is no significant, if sore is between 10 and 12, result is limit, if result is > or = 13, result is significant) | 12 weeks | 
| the induced self-competence feeling | The self-competence feeling induced will be assessed using the GSES (General Self Efficacy-Schwarzer) questionnaire (10 questions - scale 1- not at all true to 4-totally true) | 12 weeks | 
| the patients' satisfaction towards the program | Satisfaction will be measured using the Likert scale (0 no satisfy to 10: strongly satisfy | 12 weeks | 
| the patient's inflammatory biological profile | The inflammatory biological profile of the patient will be determined by correlation of cytokine levels at the beginning (T0) and end (T2) of the protocol | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, hormonotherapy, osteo articular pain, yoga, patient educational project