Health Economic Evaluation of an Adapted Physical Activity Program for Women With Breast Cancer During the Active Phase of Treatment: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 866
- 试验地点
- 1
- 主要终点
- Comparison of physical activity programmes
研究概览
简要总结
Adapted physical activity (APA) was recognized as a non-drug therapy by the French Health Authority (HAS) in 2011. Very few studies have examined the efficiency of APA programs during the active phase of treatment in cancer patients. The investigators assumed that non-drug therapy such as APA could improve the quality of life and reduces health costs. The main objective of this study is to assess the efficiency of a standardized APA program, as compared to conventional management including simple recommendations for the practice of physical activity in women in phase active breast cancer treatment.
详细描述
Scientific rationale: The incidence of breast cancer in women is on the rise again over the period 2010-2018. The overall cost of cancer treatment is 16.8 billion euros, including 3.6 billion for drugs alone. The treatments are more and more prolonged, the proportion of anticancer drugs continues to increase with 10% of the amount reimbursed for drugs delivered in pharmacies in 2017.
Adapted physical activity (APA) was recognized as a non-drug therapy by the HAS in 2011. It reduces certain side effects of treatments, as well as certain symptoms linked to the catabolic activity of the disease such as: fat gain, loss of muscle mass, physical deconditioning, fatigue or pain. For breast cancer, a meta-analysis showed that APA following adjuvant therapy may have a beneficial effect on quality of life. The APA shows in particular for breast cancer, a reduction in all-cause mortality as well as specific mortality and a reduction in recurrence.The prescription of APA has been allowed since the 2016 health law but there is no coverage by the French national health insurance fund (CNAM) despite the benefits shown. APA is only accessible in a few centers in France that have chosen to offer it to patients, thus creating social inequalities in health.
Very few studies have examined the efficiency of APA programs during the active phase of treatment. They related to cohorts of 60 to 165 patients and uses different methods. The investigators decided to set up a study that can measure the efficiency of the standardized APA programs offered to patients diagnosed with breast cancer, assuming that non-drug therapy such as APA would improve the quality of life while reducing health costs.
Description of the procedures: The intervention consists of an initial consultation appointment with a medical check-up and physical tests, then inclusion in the standardized APA program for 6 months. The control group will be offered the same initial consultation appointment with medical check-up and physical tests and will receive recommendations for physical practice as well as a calendar of activities to be practiced independently for 6 months. Inclusion in the APA program will be offered one year after inclusion.
Follow-up: The data will be collected at T0, T + 3 months, T + 6 months, T + 9 months and T + 12 months in both arms. There will be 1 year of data analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •women with breast cancer
- •any type of breast cancer, all grades, all stages
- •during treatment: surgery +/- chemotherapy +/- radiotherapy +/- hormone therapy
排除标准
- •World Health Organization (WHO) 4
- •Unstable angina
- •Uncontrolled Atrial fibrillation
- •Uncontrolled high blood pressure
- •Recent myocardial infarction or myocarditis or pericarditis or thromboembolic disease (less than 3 weeks)
- •Aortic stenosis or valve disease to operate
- •Cardiac or respiratory failure, with dyspnea at rest
- •Symptomatic anemia, thrombocytopenia
- •Lytic or painful bone metastases, Severe osteoporosis
- •Severe infectious syndrome,
- •Surgery in the last 3 weeks
- •Extreme fatigue, sharp pain, dizziness, disturbance of consciousness, severe undernutrition
- •Contraindication to the practice of an adapted physical activity programme
- •Currently involved or exclusion period of a interventional study or adapted Physical Activity program
- •Patient with protective measures (guardianship, curators, and deprivation of liberty).
- •Pregnancy or breastfeeding
- •Patient with severe functional limitations
结局指标
主要结局
Comparison of physical activity programmes
时间窗: 12 months
Evaluation of the differential cost-utility ratio (cost / QALY), according to the perspective of the community over a 12-month period, of an adapted physical activity program (APA) in comparison to conventional care, including simple recommendations for physical activity for patients with breast cancer during the active phase of treatment.
次要结局
- Breast cancer-specific quality of life(12 months)
- Patient satisfaction(12 months)
- Clinical efficacy(12 months)
- Efficacy on specific functions(12 months)
- Society impact(12 months)
- Programme compliance rate(12 months)
- Society impact (interview)(12 months)
- Rate of hospital care(12 months)
- Rate of difference in the effect of the programme(12 months)
- Rate of financial benefit of the programme(5 years)