Early Cognitive Interventions in Digital Format for Cancer Survivors (INCOTEM)
Early Cognitive Interventions in Digital Format for Cancer Survivors - INCOTEM
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.
研究概览
地位
详细说明
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:
1) To compare the acceptance and adherence of the cognitive interventions. 2) To analyze the preliminary effectiveness of the interventions on patients' cognitive functioning and quality of life at two different time points: 2.A. Upon completion of the interventions 2.B. One year after completion of the interventions
Exploratory objective:
3) Conduct an exploratory cost study of the interventions compared to CAU (Care as Usual) The study is open to patients over 18 years of age with a cancer diagnosis (stages I-III) and subjective complaints of cognitive functioning related to the cancer diagnosis and/or cancer treatments, who completed chemotherapy treatment between 1 and 6 months prior.
After a first usability session at the hospital where the interventions dynamics are introduced, the interventions will be administered remotely under supervision. A psychologist will maintain weekly contact with the participants to check everything is going well.
Participants will be assessed before the intervention begins (T0) and again 10 weeks after (T1), once the intervention has finished. The follow-up assessment (T2) will take place one year after the intervention ends to examine the sustained effects of the intervention programs.
Improving the quality of life for cancer survivors is a global challenge that this project will help to address. The interventions of this project would help to reduce the time required to successfully resume work, family, and social responsibilities.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Dr. Ander Urruticoechea Ribate
- 电话号码：+34943328000
- 邮箱：ander.urruticoechearibate@osakidetza.eus
研究联系人备份
- 姓名：Dra. Mari Feli González
- 电话号码：+34943328380
- 邮箱：mariafeliciana.gonzalezperez@osakidetza.eus
学习地点
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Bizkaia
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Bilbao、Bizkaia、西班牙、48013
- 招聘中
- Hospital Universitario Basurto
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接触：
- Dr. Ander Urruticoechea Ribate
- 电话号码：+34943328000
- 邮箱：ander.urruticoechearibate@osakidetza.eus
-
接触：
- Dra. Mari Feli González
- 电话号码：+34943328380
- 邮箱：mariafeliciana.gonzalezperez@osakidetza.eus
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首席研究员：
- Covadonga Figaredo Berjano, Dr.
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Galdakao、Bizkaia、西班牙、48960
- 招聘中
- Hospital Universitario Galdakao-Usansolo
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接触：
- Dr. Ander Urruticoechea Ribate
- 电话号码：+34943328000
- 邮箱：ander.urruticoechearibate@osakidetza.eus
-
接触：
- Dra. Mari Feli González
- 电话号码：+34943328380
- 邮箱：mariafeliciana.gonzalezperez@osakidetza.eus
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首席研究员：
- Josefa Ferreiro Quintana, Dr.
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Gipuzkoa
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San Sebastián、Gipuzkoa、西班牙、20014
- 招聘中
- Hospital Universitario Donostia
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接触：
- Dr. Ander Urruticoechea Ribate
- 电话号码：+34943328000
- 邮箱：ander.urruticoechearibate@osakidetza.eus
-
接触：
- Dra. Mari Feli González
- 电话号码：+34943328380
- 邮箱：mariafeliciana.gonzalezperez@osakidetza.eus
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首席研究员：
- Ander Urruticoechea Ribate, Dr.
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Computerized cognitive training - BrainHQ
The arm will follow the cognitive training program BrainHQ.
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Online exercises that target the following functions: attention, processing speed, memory, spatial orientation, interpersonal skills and intelligence. Participants will follow an online cognitive training with the BrainHQ program for 10 weeks. Patients will complete exercises that target attention, executive function, memory and processing speed. They will be asked to train approximately 30 minutes per BrainHQ session, 5 times per week for 10 weeks, a total of 25 hours. Training progresses in an adaptive way, based on the progression of the participant. |
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实验性的：Virtual Reality cognitive training - Enhance VR
The arm will follow the cognitive training program Enhance VR.
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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. Participants will follow a virtual reality cognitive training with the Enhance VR program for 10 weeks. Patients will complete exercises that target attention, executive function, memory and processing speed. Participants will be asked to train approximately 30 minutes per Enhance VR session, 4 times per week for 10 weeks, a total of 20 hours. Training progresses in an adaptive way, based on the progression of the participant. |
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无干预：Control Group
The arm will receive usual care with no cognitive intervention
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Perceived Cognitive Function
大体时间：Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
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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. |
Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Adherence
大体时间：Throughout the 10-week intervention
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Sufficient adherence is defined by completing at least 70% of the required exercise levels
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Throughout the 10-week intervention
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Change in Montreal Cognitive Assessment (MoCA) score
大体时间：Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention
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MoCA: screening tool aiming to detect cognitive impairment.
Total score ranges from 0 to 30, with higher scores indicating better cognitive function.
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Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention
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Change in Hopkins Verbal Learning Test-Revised (HVLT-R) score
大体时间：Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention
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The HVLT-R assesses learning and immediate and delayed verbal memory.
The number of words remembered ranges from 0 to 36 (immediate memory) and from 0 to 12 (delayed memory).
Higher scores, words remembered, are indicative of better memory.
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Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention
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Change in Trail Making Test (TMT) completion time
大体时间：Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention
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Consists of two parts, to connect numbers in ascending order and to alternate connecting numbers and letters in ascending order.
The final score is the time taken to complete the task.
The longer it takes, the poorer the cognitive performance.
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Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention
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Change in Verbal Fluency score
大体时间：Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
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Consists of phonological fluency (P-M-R) and semantic fluency (animals, fruits and vegetables).
Each word correctly given in each category counts as a point.
Higher scores mean better verbal fluency.
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Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
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Change in Digit Span (WAIS-IV) score
大体时间：Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
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Measures attention (Digits Forward) and working memory (Digits Backward).
The participant must repeat a number sequence.
Higher scores, total number sequences correctly repeated, indicate better performance.
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Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
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Change in Symbol Search (WAIS-IV) score
大体时间：Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
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Measures processing speed.
Higher scores, number of correctly correct answers, indicate better processing speed.
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Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
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Change in CANTAB Reaction Time (RTI)
大体时间：Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
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Cognitive test (higher score indicating better outcome).
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Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
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Change in CANTAB Rapid Visual Information Processin (RVP)
大体时间：Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
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Cognitive test (higher score indicating better outcome)
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Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
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Change in CANTAB Delayed Matching to Sample (DMS)
大体时间：Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
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Cognitive test (higher score indicating better outcome)
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Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
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Change in CANTAB Paired Associated Matching (PAL)
大体时间：Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
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Cognitive test (higher score indicating better outcome)
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Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
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Change in CANTAB Spatial Working Memory (SWM)
大体时间：Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
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Cognitive test (higher score indicating better outcome)
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Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
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Change in CANTAB One Touch Stockings of Cambridge (OTS)
大体时间：Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
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Cognitive test (higher score indicating better outcome)
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Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
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Change in Hopkins Verbal Learning Test-Revised (HVLT-R) score
大体时间：Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
|
Assesses learning and immediate and delayed verbal memory.
The number of words remembered ranges from 0 to 36 (immediate memory) and from 0 to 12 (delayed memory).
Higher scores, words remembered, are indicative of better memory.
|
Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
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Change in Fatigue
大体时间：Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
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EORTC - QCL - FA-12, is a 12-item Likert scale.
It evaluates the physical, emotional, and cognitive aspects of fatigue and the interference of it with daily activities and social life in the last 7 days.
The items range from 1 to 4 with higher values representing higher symptomatology.
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Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
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Change in Sleep Disturbance
大体时间：Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
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Insomnia Severity Index - ISI.
It consists of 7 questions asking for difficulties of falling asleep, staying asleep, and problems with waking up too early, current sleep patterns and the effects of sleep on quality of life.
Higher scores indicate more sleep problems.
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Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
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Change in Anxiety and Depression symptoms
大体时间：Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
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Hospital Anxiety and Depression Scale (HADS).
It is used to assess anxiety and depression in a hospital setting.
This scale consisted of 14 questions, where half of the questions are related to anxiety and the other half to depression.
Each item ranges from 0 to 3. Higher scores indicate the presence of anxiety and/or depression.
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Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
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Change in overall Quality of Life
大体时间：Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
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EORTC QLQ-C-30.
This assessment consisted of 30 questions addressing several aspects of quality of life in cancer patients (Functioning scales: physical, emotional, social, cognitive and role; Symptoms scales: fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, constipation and diarrhea symptoms, plus financial difficulties and global health status / quality of life scale).
For each scale, scores range from 0 to 100, with higher scores indicating good functioning in the functioning scales and more symptoms burden in the symptoms scales.
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Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
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Change in Work Ability Index (WAI)
大体时间：Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
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The first two items of the WAI scale rated the current work ability on a Likert scale from 1 to 10 and the current work ability with respect to the physical and the mental demands of the work.
On both items higher scores reflect better work ability.
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Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
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Change in adherence medication
大体时间：Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
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Morisky Medication Adherence Scale (MMAS-8) (MMAS-8).
The scale consists of 8 items.
Response choices are "yes" or "no" for items 1-7 and Item 8 has a five-point Likert response scale.
Total scores on the MMAS-8 range from 0 to 8, with higher scores meaning higher adherence.
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Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
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Patient Satisfaction
大体时间：Thoughout the 10-week intervention.
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Net Promoter Score (NPS), assesses satisfaction with a specific product or service by asking how likely that person is to recommend it to someone else on a scale of 0 (not at all likely) to 10 (extremely likely).
The final score is calculated by dividing the percentage of promoters (those who score 9-10) by the percentage of detractors (those who score 0-6).
The NPS range varies between -100 and +100, with a positive score being considered acceptable and the higher the score, the more acceptable it is considered to be.
Client Satisfaction Questionnaire (CSQ-8).
Likert-based 8-item questionnaire rating overall satisfaction and acceptability.
The 8 items are scored on a 4-point scale (total range from 8-32) with higher scores indicating greater acceptability and satisfaction.
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Thoughout the 10-week intervention.
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Subjective experience with the exercises
大体时间：At the usability session.
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Game Experience Questionnaire (GEQ).
The Core Module consists of 33 items which assess game experience on seven components: Immersion, Flow, Competence, Positive and Negative Affect, Tension, and Challenge.
Each item is rated from 0 (Not at all) to 4 (Extremely).
High score in a concrete dimension means intense experience on that dimension.
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At the usability session.
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Usability
大体时间：Thoughout the 10-week intervention.
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System Usability Scale (SUS), is a 10-item self-report measure designed for usability assessment.
Items are rated on a 5- 8 point Likert scale (1 = strongly disagree, 5 = strongly agree).
Total SUS scores have a range of 0 to 100, being higher scores in the SUS indicative of greater usability.
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Thoughout the 10-week intervention.
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合作者和调查者
出版物和有用的链接
一般刊物
- Bray VJ, Dhillon HM, Bell ML, Kabourakis M, Fiero MH, Yip D, Boyle F, Price MA, Vardy JL. Evaluation of a Web-Based Cognitive Rehabilitation Program in Cancer Survivors Reporting Cognitive Symptoms After Chemotherapy. J Clin Oncol. 2017 Jan 10;35(2):217-225. doi: 10.1200/JCO.2016.67.8201. Epub 2016 Oct 28.
- Hutchinson AD, Hosking JR, Kichenadasse G, Mattiske JK, Wilson C. Objective and subjective cognitive impairment following chemotherapy for cancer: a systematic review. Cancer Treat Rev. 2012 Nov;38(7):926-34. doi: 10.1016/j.ctrv.2012.05.002. Epub 2012 Jun 2.
- Koppelmans V, Breteler MM, Boogerd W, Seynaeve C, Gundy C, Schagen SB. Neuropsychological performance in survivors of breast cancer more than 20 years after adjuvant chemotherapy. J Clin Oncol. 2012 Apr 1;30(10):1080-6. doi: 10.1200/JCO.2011.37.0189. Epub 2012 Feb 27.
- Lange M, Joly F. How to Identify and Manage Cognitive Dysfunction After Breast Cancer Treatment. J Oncol Pract. 2017 Dec;13(12):784-790. doi: 10.1200/JOP.2017.026286.
- Janelsins MC, Kesler SR, Ahles TA, Morrow GR. Prevalence, mechanisms, and management of cancer-related cognitive impairment. Int Rev Psychiatry. 2014 Feb;26(1):102-13. doi: 10.3109/09540261.2013.864260.
- Zeng Y, Guan Q, Su Y, Huang Q, Zhao J, Wu M, Guo Q, Lyu Q, Zhuang Y, Cheng AS. A self-administered immersive virtual reality tool for assessing cognitive impairment in patients with cancer. Asia Pac J Oncol Nurs. 2023 Feb 28;10(3):100205. doi: 10.1016/j.apjon.2023.100205. eCollection 2023 Mar.
- Wu LM, Amidi A, Tanenbaum ML, Winkel G, Gordon WA, Hall SJ, Bovbjerg K, Diefenbach MA. Computerized cognitive training in prostate cancer patients on androgen deprivation therapy: a pilot study. Support Care Cancer. 2018 Jun;26(6):1917-1926. doi: 10.1007/s00520-017-4026-8. Epub 2017 Dec 27.
- Von Ah D, Crouch A, Storey S. Acceptability of computerized cognitive training and global cognitive stimulating-based games delivered remotely: Results from a randomized controlled trial to address cancer and cancer-related cognitive impairment in breast cancer survivors. Cancer Med. 2023 Jun;12(11):12717-12727. doi: 10.1002/cam4.5904. Epub 2023 Apr 11.
- Von Ah D, McDonald BC, Crouch AD, Ofner S, Perkins S, Storey S, Considine R, Unverzagt F. Randomized double-masked controlled trial of cognitive training in breast cancer survivors: a preliminary study. Support Care Cancer. 2022 Sep;30(9):7457-7467. doi: 10.1007/s00520-022-07182-4. Epub 2022 Jun 1.
- Serweta-Pawlik A, Lachowicz M, Zurek A, Rosen B, Zurek G. Evaluating the Effectiveness of Visuospatial Memory Stimulation Using Virtual Reality in Head and Neck Cancer Patients-Pilot Study. Cancers (Basel). 2023 Mar 7;15(6):1639. doi: 10.3390/cancers15061639.
- Runowicz CD, Leach CR, Henry NL, Henry KS, Mackey HT, Cowens-Alvarado RL, Cannady RS, Pratt-Chapman ML, Edge SB, Jacobs LA, Hurria A, Marks LB, LaMonte SJ, Warner E, Lyman GH, Ganz PA. American Cancer Society/American Society of Clinical Oncology Breast Cancer Survivorship Care Guideline. J Clin Oncol. 2016 Feb 20;34(6):611-35. doi: 10.1200/JCO.2015.64.3809. Epub 2015 Dec 7.
- Mayo SJ, Rourke SB, Atenafu EG, Vitorino R, Chen C, Kuruvilla J. Computerized cognitive training in post-treatment hematological cancer survivors: a feasibility study. Pilot Feasibility Stud. 2021 Jan 30;7(1):36. doi: 10.1186/s40814-021-00778-3.
- Lange M, Licaj I, Clarisse B, Humbert X, Grellard JM, Tron L, Joly F. Cognitive complaints in cancer survivors and expectations for support: Results from a web-based survey. Cancer Med. 2019 May;8(5):2654-2663. doi: 10.1002/cam4.2069. Epub 2019 Mar 18.
- Joly F, Giffard B, Rigal O, De Ruiter MB, Small BJ, Dubois M, LeFel J, Schagen SB, Ahles TA, Wefel JS, Vardy JL, Pancre V, Lange M, Castel H. Impact of Cancer and Its Treatments on Cognitive Function: Advances in Research From the Paris International Cognition and Cancer Task Force Symposium and Update Since 2012. J Pain Symptom Manage. 2015 Dec;50(6):830-41. doi: 10.1016/j.jpainsymman.2015.06.019. Epub 2015 Sep 5.
- Garcia-Torres F, Tejero-Perea A, Gomez-Solis A, Castillo-Mayen R, Jaen-Moreno MJ, Luque B, Galvez-Lara M, Sanchez-Raya A, Jablonski M, Rodriguez-Alonso B, Aranda E. Effectiveness of the Unified Barlow Protocol (UP) and neuropsychological treatment in cancer survivors for cognitive impairments: study protocol for a randomized controlled trial. Trials. 2022 Sep 30;23(1):819. doi: 10.1186/s13063-022-06731-w.
- Brugada-Ramentol V, Bozorgzadeh A, Jalali H. Enhance VR: A Multisensory Approach to Cognitive Training and Monitoring. Front Digit Health. 2022 Jun 3;4:916052. doi: 10.3389/fdgth.2022.916052. eCollection 2022.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- INCOTEM
- BIO24/CA/020/BG (其他标识符：Fundación Vasca de Innovación e Investigación Sanitarias)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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