EvalUation of REmediation Programs for Patients Suffering From Mild Cognitive Deficits After CAncer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 4
- 主要终点
- Self-reported cognitive function
研究概览
简要总结
Cancer survival rates have improved significantly over the past decades and patients now experience a number of side effects including cancer-related cognitive impairment (CRCI): problems with memory, executive function, attention, and difficulties performing two tasks at the same time. The frequency of CRCI in cancer patients is estimated to be between 10 to 40%, and more than 50% of patients describe difficulties in their daily life. These cognitive difficulties negatively impact the patient's quality of life as well as that of their family, and can also have negative consequences for their social and professional reintegration once cancer treatment is finished. Despite an increasing number of studies on CRCI, a standard of care for patients with CRCI after breast cancer is yet to be established. In the absence of clear directives, and in an attempt to respond to the increasing demand to provide care for breast cancer patients with CRCI, physical medicine and rehabilitation units in France have started providing day-hospital multidisciplinary interventions. The objective of this project is to use the single case experimental design method to investigate the efficacy of two such rehabilitation programs: a group-based program and a one-on-one program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Treated in the past for breast cancer with chemotherapy, surgery, and / or radiotherapy,
- •Admitted as a day patient at the Henry Gabrielle Hospital or the Pontchaillou CHU Hospital during the study,
- •Given free, informed consent in writing after being informed orally and in writing of the how the study will proceed.
排除标准
- •Presence of another active cancer,
- •Ongoing chemotherapy and/or radiotherapy treatment,
- •Active progression of breast cancer,
- •History of neurological or psychiatric conditions,
- •Major disturbances in comprehension that prevent them giving free, informed consent,
- •Pregnant, parturient or breastfeeding women,
- •Person under a legal protection measure such as guardianship or curatorship,
- •People not affiliated to a social security scheme (French Social Security) or beneficiaries of a similar scheme.
结局指标
主要结局
Self-reported cognitive function
时间窗: 16 weeks
The Fact-COG questionnaire assesses subjective cognitive impairment. The score directly reflects the patient's feelings about/perceptions of their cognitive function over the previous week. A total score out of 132 is obtained as well as 4 subscales: Perceived Cognitive Impairments (0-72), Impact on Quality of Life (0-16), Comments from Others (0-16), and Perceived Cognitive Abilities (0-28).
次要结局
- Fatigue(16 weeks)
- Psychological distress(16 weeks)
- Quality of Life with FACT-B questionnaire(16 weeks)
- Neuropsychological function(16 weeks)