Feasibility Study of the "SKYPE" Educational Project in Patients With Breast Cancer Treated With Hormonotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- proportion of patient compliance to the educational yoga program
研究概览
简要总结
As much as 45 to 60% 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.
With this project, the investigators will assess the feasibility of a therapeutic yoga program with home practice for patients with breast cancer treated with hormonotherapy. The investigators will measure adhesion of the patients to perform yoga postures in an autonomous manner. Our study will also allow collection of data on the effect of such a program on quality of life, in view of setting-up an intervention study.
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
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（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 hormonotherapy, with no treatment modification in the 30 days before inclusion
- •Osteoarticular pain ≥ 4 (resting or moving) on the VAS (Visual Analogue Scale)
- •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 category
排除标准
- •Chronic rheumatologic pain with specific care needed
- •Yoga practice in the 3 months before inclusion
- •Contra-indication or clinical state not allowing physical practice
研究组 & 干预措施
Therapeutic educational postural yoga program
Daily 15-min yoga sessions at home during 12 weeks. One 90-min yoga-therapeutic education session/week (during 6 weeks).
干预措施: educational yoga program (Behavioral)
结局指标
主要结局
proportion of patient compliance to the educational yoga program
时间窗: 12 weeks
Compliance will be posittive if 70% of daily sessions at home and 4 sessions out of the 6 therapeutic educational (TEP) sessions delivered in the center by a physical therapist are realised
次要结局
- To assess quality of life by Quality of Life Questionnaire specify for Breast Cancer(12 weeks)
- the patients' satisfaction towards the program(12 weeks)
- the induced self-competency feeling(12 weeks)
- Osteoarticular pain(12 weeks)
- Compliance to hormonotherapy treatment(12 weeks)
- Reasons of non-participation to the study.(at baseline)
- To assess quality of life by Quality of Life Questionnaire(12 weeks)
- To assess fatigue and stress(12 weeks)
- Forward-flexion flexibility(12 weeks)
- Respiratory capacity(12 weeks)
- Anxiety and depression prevalence(12 weeks)
- Patient enrolment rate(at baseline)