Effect of a Tailored Program of Physical Activity and Nutritional Therapeutic Education on Clinical, Psychological and Sociological Factors in Breast Cancer Patients Undergoing Adjuvant Treatment : Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 360
- 试验地点
- 16
- 主要终点
- Rate of cancer-related fatigue
研究概览
简要总结
This multicenter randomized controlled trial aims to evaluate the effect of a tailored program of physical activity and nutritional therapeutic education on clinical, psychological and sociological factors in breast cancer patients undergoing adjuvant treatment.
详细描述
The experimental arm "APAD": tailored PA program associated with individual nutritional counseling whilst hospitalization and at home during the 26-week duration of adjuvant treatment
The experimental program will include:
- 8 PA sessions supervised at the hospital centers and 44 unsupervised home sessions, to be performed twice a week.
- 6 consultations for nutrition education to teach the principles of well balanced diet, to foster weigh control during treatment, and to induce appropriate feeding behaviors after treatment.
The control arm: standard of care
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
- •Female patient with histologically proven breast cancer
- •Age ≥18 years old
- •Patients having undergone curative surgery and eligible to 6 cycles of adjuvant chemotherapy (6 FEC100, or 3FEC100 + 3 taxanes) followed by radiotherapy
- •Satisfactory healing from surgical act on breast and lymph nodes
- •Ability to understand the nature, goal and study methodology
- •Consent to cooperate for clinical assessments
- •Affiliation to a social security regime or beneficiary of equivalent social protection
- •Written informed consent provided before any study specific procedures
排除标准
- •Metastatic disease
- •Any other primary tumor
- •Contra-indication to moderate physical activity: Unchecked high blood pressure; family history of sudden death in a first degree relative; not stabilized heart disease; acute or chronic lung disease resulting in dyspnea for moderate effort; uncontrolled diabetes, carrying a stent; other severe pathologies unstabilized, disabled or not indicated to physical practice.
- •Contra-indication to adjuvant chemotherapy or radiotherapy
- •Pregnancy or breast feeding (according to the recommendations of the usual adjuvant breast cancer)
- •Inability to attend or comply with interventions or follow-up scheduling, disability or difficulty preventing a proper understanding of trial instructions
- •Legal inability or restricted legal ability
研究组 & 干预措施
Control
Standard of care
Adapted Physical Activity and Dietetique
tailored PA program associated with individual nutritional counseling whilst hospitalization and at home during the 26-week duration of adjuvant treatment
干预措施: APAD (Other)
结局指标
主要结局
Rate of cancer-related fatigue
时间窗: 6 months
The primary assessment criterion is subjective fatigue measured using the 'General Fatigue' subscale of the Multidimensional Fatigue Inventory (MFI-20) questionnaire.
次要结局
未报告次要终点