Cognitive Rehabilitation of Glioma Patients: a Prospective, Randomized Study
试验速览
- 阶段
- 3 期
- 发起方
- UMC Utrecht
- 入组人数
- 140
- 试验地点
- 18
- 主要终点
- neuropsychological measures of attention (test scores)
研究概览
简要总结
The purpose of this study is to determine whether cognitive rehabilitation is effective in patients with gliomas (brain tumour), by comparing direct and follow-up neuropsychological functioning and quality of life of the experimental group to the control group.
详细描述
The majority of patients with (low-grade) glioma exhibit cognitive symptoms and objective deficits, which have a sustained, negative impact on daily functioning and quality of life.
Adult patients with a low-grade glioma, either histologically proven, or suspected (1), as well as adult anaplastic glioma patients with favorable prognostic factors (2), who are clinically stable for at least 6 months, will be recruited from 9 hospitals in the Netherlands. Consenting patients with both subjective cognitive symptoms and objective deficits will be randomized to either the cognitive rehabilitation program (N = 75) or a "waiting-list" control group (N = 75). Upon completion of the study, those patients assigned to the control group will be given the opportunity to undergo the cognitive rehabilitation program.
The cognitive rehabilitation program incorporates both retraining of impaired cognitive functions, and teaching of compensatory strategies. Rehabilitation will be directed towards attention, memory and executive functioning. The intervention will consist of 6 weekly, individual, 2-hour sessions plus two hours of homework.
To evaluate the efficacy of the rehabilitation program, objective neuropsychological functioning, self-reported cognitive symptoms and health-related quality of life will be assessed before rehabilitation, directly following rehabilitation, and at 6-month follow-up.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients with a histologically proven low-grade glioma or presumed (i.e., suspected) low-grade glioma based on both clinical and MR imaging feature, and
- •adult patients with an anaplastic glioma (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oligo-astrocytoma) under age 50 and with good performance status (KPS > 70);
- •who are clinically stable for a minimum of 6 months prior to study entry (as determined by recent CT or MRI imaging) and no anti-tumor treatment during that period of time (i.e., surgery, radiotherapy, chemotherapy, corticosteroids);
- •who report at least one symptom of impaired cognitive functioning based on a standardized self-report questionnaire, administered by researcher;
- •and who meet criteria for neuropsychological impairment based on objective test results (assessed by researcher).
排除标准
- •lack of basic proficiency in Dutch;
- •IQ below 85;
- •severe reading problems;
- •an additional (history of) neurological or psychiatric disorder;
- •participating in a concurrent study in which neuropsychological testing and/or health-related quality of life assessments are involved
结局指标
主要结局
neuropsychological measures of attention (test scores)
时间窗: baseline, immediately after 6 weeks and at 6-month follow-up
次要结局
- neuropsychological measures of memory and executive functioning (test scores)(baseline, immediately after 6 weeks and at 6-month follow-up)
- subjective neuropsychological functioning (questionnaires)(baseline, immediately after 6 weeks and at 6-month follow-up)
- quality of life (questionnaires)(baseline, immediately after 6 weeks and at 6-month follow-up)