Contextualized Neuropsychological Rehabilitation for CNS Cancer Survivors: The "I'm Aware: Patients and Carers Together" (ImPACT) Program"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Self-reported cognitive functioning
研究概览
简要总结
The aim of the present randomized-controlled study is to evaluate the feasibility, acceptability, and preliminary efficacy of a novel, context-sensitive neuropsychological rehabilitation intervention for brain cancer survivors.
详细描述
Cognitive impairment is the most common late effect in brain cancer survivors, with profound negative effects on quality of life, work ability, and socioeconomic outcomes. Still, there is no gold standard approach to treating cognitive impairment in brain cancer survivors. Furthermore, there is a dearth of research on interventions to treat cognitive impairment in brain cancer survivors, and the relatively few studied interventions have proven limited effects. Arguably, four key elements are missing from a majority of studied interventions:1) transfer of learning to real-world functional outcomes, 2) awareness training to enhance compensatory strategy use, 3) inclusion of carers that could enhance transfer of learning to the home, and 4) recognition of the inter-related nature of cognitive, neurobehavioral, and psychological functions.
The "I'M aware: Patients and Carers Together (ImPACT)" program is a novel, context-sensitive neuropsychological rehabilitation intervention that targets the above mentioned missing elements in previous rehabilitation efforts. The present feasibility randomized-controlled study aims to evaluate the feasibility, acceptability, and preliminary efficacy of this program in brain cancer survivors with cognitive impairment in preparation for a subsequent large-scale randomized controlled trial.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of brain cancer
- •Completed primary treatment at least 6 months ago
- •Medically stable
- •Speaks and understand Danish
- •Living with a carer aged 18 or over, who also speaks and understands Danish and consents to participate in the study alongside the patient
排除标准
- •Confounding diagnosed or suspected psychiatric or medical condition unrelated to the cancer or its treatment
结局指标
主要结局
Self-reported cognitive functioning
时间窗: Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
The Patients Assessment of Own Functioning Inventory (PAOFI). 33 items: answer format range 1-6; total score range: 0-33. Higher score indicates more impairment.
Carer-reported cognitive functioning
时间窗: Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
The Patients Assessment of Own Functioning Inventory (PAOFI) modified to informant version. 33 items: answer format range 1-6; total score range: 0-33. Higher score indicates more impairment.
Carer-reported neurobehavioral functioning
时间窗: Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
The carer-report version of the Frontal Systems Behavior Scale (FrSBe). 46 items: answer format range 1-5; total score range: 46-230. Higher score indicates more impairment.
Self-reported neurobehavioral functioning
时间窗: Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3)
The self-report version of the Frontal Systems Behavior Scale (FrSBe). 46 items: answer format range 1-5; total score range: 46-230. Higher score indicates more impairment.
次要结局
- Carer-reported mental fatigue(Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)])
- Carer-reported health-related quality of life(Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)])
- Self-reported community integration(Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)])
- Premorbid intellectual functioning (Patient only)(Baseline (T1))
- Self-reported cognitive functioning(Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)])
- Self-reported fatigue(Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)])
- Carer-reported cognitive functioning(Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)])
- Carer-reported neurobehavioral functioning(Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)])
- Objective cognitive functioning (Neuropsychological tests; Patient only)(Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)])
- Depression (patient only)(Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)])
- Self-reported health-related quality of life(Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)])
- Self-reported participant satisfaction(Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)])
- Self-reported neurobehavioral functioning(Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)])
- Self-reported mental fatigue(Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)])
- Carer-reported community integration(Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)])
- Self-reported participant motivation(Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)])
- Carer-reported fatigue(Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)])
- Insomnia(Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)])
- Carer-reported participant satisfaction(Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)])
- Carer-reported participant motivation(Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)])
研究者
Lisa Maria Wu
Associate Professor
Aarhus University Hospital