Study of Impact of Adapted Physical Activity on Cognitive Functions and Quality of Life in Patients Treated for Locally Advanced Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 6
- 主要终点
- proportion of patient with an increase of Functional Assessment of Cancer Therapy-Cognitive Function (FACT-COG) result
研究概览
简要总结
Breast cancer is the most frequent cancer in women in western countries. The improvement of therapeutic management associated to the developement of supportive care allows patient to live longer in better conditions. But several studies have showed the deleterious impact of treatment such as chemotherapy on cognition. To limit these damages, non therapeutic approaches such as Adapted Physical Activity (APA) have been developped.
The goal of this study is to evaluate the benefit of APA program on cognitive functions in patients with locally advanced breast cancer.
详细描述
Patient with cognitive complaint will be randomized in two groups :
- Experimental group : Immediate APA program (after randomization)
- Standard group : Delayed APA program (3 months after randomization)
APA program contains 10 sessions of APA within five weeks (twice a week). Each session is composed of 5 exercises (each made of 3 serial of 7 repetitions in slow speed).
A cognitive and quality of life assessments will occur in two groups at 3 and 6 months after randomization.
The primary objective of the study is to evaluate the impact of APA program on the improvement of cognitive functions in patients with breast cancer who have been treated by adjuvant chemotherapy.
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
- •More than 18 years old
- •Locally advanced breast cancer
- •Patient who undergone surgery
- •Cognitive complaint (FACT-COG inferior or equal to 8/16)
- •No metastasis at the inclusion
- •Patient who received adjuvant therapy by chemotherapy
- •Patient with a social protection
- •Barbizet scale Superior or equal to 3
- •No neurological history
- •No medical contraindication to APA
- •Inform consent signed
排除标准
- •Metastatic breast cancer
- •History of other cancer (in 5 years before inclusion)
- •Current chemotherapy or radiotherapy
- •Chemotherapy or radiotherapy ended for more than 6 months
- •Current APA program
- •Blood transfusion for less than 6 mois
- •Minimal mental score inferior to normal
- •Patient no able to respond to the cognitive test
- •Patient no able to realize APA program
- •Alcohol abuse
- •Patient Under guardianship or curatorship or deprived of liberty
研究组 & 干预措施
Immediate APA
intervention: 10 sessions of APA within the 5 weeks (2 sessions per week) following the randomization
干预措施: immediate APA program (Other)
Delayed APA
intervention: 10 sessions of APA in 5 weeks (2 sessions per week) , 3 months after randomization
干预措施: delayed APA program (Other)
结局指标
主要结局
proportion of patient with an increase of Functional Assessment of Cancer Therapy-Cognitive Function (FACT-COG) result
时间窗: After APA program
Proportion of patient with an increase superior or equal to seven points between FACT-COG at the inclusion and FACT-COG after APA program
次要结局
- Comparison of immediate APA and delayed APA on quality of life(30 months)
- Improval of quality of life(After APA program)
- Study of relations between cognitive functions and quality pf life(After APA program)