Physical and Moral Benefits of Adapted Fencing in Patients With Invasive Breast Cancer: Pilot Study of a Randomized Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 24
- 试验地点
- 3
- 主要终点
- Change from baseline score of Quality of Life Questionnaire Core 30 (QLQ-C30) at 3 months.
研究概览
简要总结
Literature have shown the benefit of practicing regular physical activity during and after cancer treatment, particularly in terms of improving quality of life. The French Fencing Federation has thus developed an adapted physical activity program (Solution RIPOSTE) specially intended for patients with breast cancer. Adapted fencing sessions (saber) are thus offered to these patients in a perfectly secure context (i.e. compulsory medical-sports evaluation and trained fencing master). Since 2016, this RIPOSTE program has been implemented in several fencing halls in Lorraine. Our research project (controlled, randomized trial) aims to assess the impact of the practice of adapted fencing on the quality of life of patients, the functional capacities of the operated side (shoulder) and on the reduction of the sides effects of treatments. Our hypothesis is that such an adapted fencing program improves quality of life as well as functional abilities.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Be a woman
- •≥ 18 years old.
- •Have undergone unilateral breast surgery for primary invasive breast cancer
- •Time between surgery and inclusion between 2 to 4 weeks after surgery
- •Accept and be able to complete self-administered questionnaires
- •Satisfy the prior medico-sports evaluation
- •Be affiliated to a social security scheme or beneficiary of such a scheme
- •Have received full information on the organization of the research and have signed their informed consent.
排除标准
- •Presence of bone metastases, especially vertebral
- •Presence of a contraindication to the practice of fencing during the medico-sports evaluation (post-surgery period that is too painful and / or requiring specific treatment in rehabilitation)
- •Refusal to participate in the study
- •Woman of childbearing age who does not have effective contraception.
- •Persons referred to Articles L.1121-5, L.1121-7 and L. 1121-8 of the Public Health Code
- •Pregnant woman, parturient or nursing mother
- •Minor (non-emancipated)
- •Adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice)
- •Person of full age unable to express consent
- •Persons deprived of their liberty by a judicial or administrative decision, persons undergoing psychiatric treatment under Articles L. 3212-1 and L. 3213-1.
研究组 & 干预措施
Early Fencing
patients of the "Early Fencing" arm will start adapted fencing practice (1h30/week) within 4 weeks after the breast surgery and for a duration of 3 months
干预措施: Adapted Physical Activity (Other)
Delayed Fencing
patients of the "Delayed Fencing" arm will start adapted fencing practice (1h30/week) 3 months after the breast surgery and for a duration of 3 months
干预措施: Adapted Physical Activity (Other)
结局指标
主要结局
Change from baseline score of Quality of Life Questionnaire Core 30 (QLQ-C30) at 3 months.
时间窗: Baseline (J0) and at 3 months (M3)
Questionnaire. 30 items. minimum value = 30. Maximum value = 120. A high score means a worse outcome (i.e. poor quality of life)
次要结局
- Change from baseline score of Multidimensional Fatigue Inventory (MFI-20) at 3 months(Baseline (J0) and at 3 months (M3))
- Change from baseline score of Disabilities of the Arm, Shoulder and Hand measurement tool (DASH) at 3 months(Baseline (J0) and at 3 months (M3))
- Change from baseline score of Hospital Anxiety and Depression Scale at 3 months.(Baseline (J0) and at 3 months (M3))
研究者
Mathias POUSSEL, MD, PhD
Clinical Professor
Central Hospital, Nancy, France