Early Cognitive Interventions in Digital Format for Cancer Survivors - INCOTEM
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 3
- 主要终点
- Change in Perceived Cognitive Function
研究概览
简要总结
The aim of this study is to evaluate the usability and effectiveness of two professionally supervised home-based cognitive training interventions as part of an early rehabilitation protocol for cancer-related cognitive impairment.
Participants will be randomized to one of the two intervention arms (computerized cognitive intervention or virtual reality cognitive intervention) or to the control group. Participants of the intervention groups will be assessed before and after the 10 weeks intervention or at equivalent time points for the control group. Comparisons between experimental and control participants, and between the participants in the two intervention arms, will be carried out to see which intervention is most effective and accepted.
详细描述
One of the adverse effects of cancer and its treatments is cognitive decline, which can affect up to 70% of patients throughout the course of their cancer journey. This decline leads to significant difficulties in resuming professional or social roles, among others, and to a reduced quality of life. Results from previous studies suggest that cognitive intervention can help restore affected functions. Within the framework of this project, two digital cognitive intervention platforms (BrainHQ and Enhance VR) have been selected because they offer advantages that make them viable, accessible and effective, such as: (1) being based on proven psychological paradigms; (2) providing a sufficient variety of exercises and difficulty levels; and (3) the ability to be administered at home. Virtual reality (VR) is demonstrating its potential in the healthcare field because it could help address the limitations of transfer and adherence in some cognitive intervention programs. In general, the virtual reality interventions are more ecological, so it is expected that the results will translate more effectively to the patient's daily activities. On the other hand, the greater immersion provides by VR increases motivation and, therefore, improves adherence to this type of interventions.
BrainHQ program consists of online exercises that target the following functions: attention, processing speed, memory, spatial orientation, interpersonal skills and intelligence. BrainHQ will be compared with the Enhace VR cognitive intervention, a library of 15 cognitive exercises developed in virtual reality to train and monitor specific cognitive functions (memory, attention, task flexibility, information processing, orientation, and problem-solving) and motor control.
The interventions will be implemented after the completion of cancer treatments (1-6 months post-chemotherapy) with the aim of promoting early detection of cognitive impairment and preventing it from becoming chronic over time. This will help patients resume their previous roles quickly and effectively.
The purpose of this randomized controlled trial is to test the usability and effectiveness of two digital cognitive interventions in cancer survivors in comparison with a control group.
The specific objectives are:
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
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years of age diagnosed with cancer (stage I-III)
- •Subjective complaints of cognitive functioning related to the diagnosis of cancer and/or cancer treatments
- •Between 1-6 months after completion of chemotherapy treatment
- •To have Wi-Fi and a computer/tablet
- •To sign the informed consent form
排除标准
- •Previous history of cancer diagnosis
- •Anticipated change in cancer treatment/general medical treatment during the intervention period
- •Previous diagnosis of cognitive impairment
- •Diagnosis of other neurological or psychiatric diseases
- •Diagnosis of severe untreated depression
- •History of episodes of vertigo, epilepsy or seizures
- •Currently undergoing or having undergone any other type of intervention aimed at improving cognitive functioning (e.g., CRCI workshops)
- •Severe visual or hearing difficulties that may affect the performance of the intervention exercises
- •Inability to speak, understand, read, and write Spanish correctly
- •Failure to sign the informed consent form
结局指标
主要结局
Change in Perceived Cognitive Function
时间窗: Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
Functional Assessment of Cancer Therapy-Cognition, FACT-Cog v3 Self-report questionnaire for cancer patients with cognitive problems consisting of 37 items divided in 4 subscales: Perceived Cognitive Impairment (PCI), Perceived Cognitive Abilities (PCA), Comments From Others (OTH), and Impact on Quality of Life (QoL). The items asked for the past 7 days and are rated on a 5-point Likert scale. Higher scores are indicative of a better cognitive function and QoL.
次要结局
- Adherence(Throughout the 10-week intervention)
- Change in Montreal Cognitive Assessment (MoCA) score(Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention)
- Change in CANTAB Reaction Time (RTI)(Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.)
- Change in Hopkins Verbal Learning Test-Revised (HVLT-R) score(Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention)
- Change in Trail Making Test (TMT) completion time(Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention)
- Change in Verbal Fluency score(Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.)
- Change in Digit Span (WAIS-IV) score(Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.)
- Change in Symbol Search (WAIS-IV) score(Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.)
- Change in CANTAB Rapid Visual Information Processin (RVP)(Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.)
- Change in CANTAB Delayed Matching to Sample (DMS)(Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.)
- Change in CANTAB Paired Associated Matching (PAL)(Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.)
- Change in CANTAB Spatial Working Memory (SWM)(Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.)
- Change in CANTAB One Touch Stockings of Cambridge (OTS)(Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.)
- Change in Hopkins Verbal Learning Test-Revised (HVLT-R) score(Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.)
- Change in Fatigue(Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.)
- Change in Sleep Disturbance(Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.)
- Change in Anxiety and Depression symptoms(Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.)
- Change in overall Quality of Life(Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.)
- Change in Work Ability Index (WAI)(Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.)
- Change in adherence medication(Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.)
- Patient Satisfaction(Thoughout the 10-week intervention.)
- Subjective experience with the exercises(At the usability session.)
- Usability(Thoughout the 10-week intervention.)