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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 108
- 试验地点
- 12
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: no intervention (Other)
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.
干预措施: educational yoga program (Behavioral)
结局指标
主要结局
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.
时间窗: 12 weeks
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).
次要结局
- the evolution of osteoarticular and/or musculoskeletal pain characteristics related to hormone therapy(12 weeks)
- the reasons for adhesion or non-adhesion to yoga self-practice(12 weeks)
- To assess forward-flexion flexibility(12 weeks)
- the hormone therapy treatment and its compliance(12 weeks)
- to assess quality of life by short form questionnaire(12 weeks)
- to assess fatigue(12 weeks)
- to assess quality of life by Quality of Life Questionnaire specify for Breast Cance(12 weeks)
- the patient compliance at yoga-therapeutic education session and yoga self-practice(12 weeks)
- to assess quality of life by Quality of Life Questionnaire(12 weeks)
- the induced self-competence feeling(12 weeks)
- To assess respiratory capacity(12 weeks)
- anxiety and depression(12 weeks)
- the patients' satisfaction towards the program(12 weeks)
- the patient's inflammatory biological profile(12 weeks)