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.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
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.
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究連絡先
研究連絡先
- 名前：Dr. Ander Urruticoechea Ribate
- 電話番号：+34943328000
- メール：ander.urruticoechearibate@osakidetza.eus
研究連絡先のバックアップ
- 名前：Dra. Mari Feli González
- 電話番号：+34943328380
- メール：mariafeliciana.gonzalezperez@osakidetza.eus
研究場所
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Bizkaia
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Bilbao、Bizkaia、スペイン、48013
- 募集
- Hospital Universitario Basurto
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コンタクト：
- Dr. Ander Urruticoechea Ribate
- 電話番号：+34943328000
- メール：ander.urruticoechearibate@osakidetza.eus
-
コンタクト：
- Dra. Mari Feli González
- 電話番号：+34943328380
- メール：mariafeliciana.gonzalezperez@osakidetza.eus
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主任研究者：
- Covadonga Figaredo Berjano, Dr.
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Galdakao、Bizkaia、スペイン、48960
- 募集
- Hospital Universitario Galdakao-Usansolo
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コンタクト：
- Dr. Ander Urruticoechea Ribate
- 電話番号：+34943328000
- メール：ander.urruticoechearibate@osakidetza.eus
-
コンタクト：
- Dra. Mari Feli González
- 電話番号：+34943328380
- メール：mariafeliciana.gonzalezperez@osakidetza.eus
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主任研究者：
- Josefa Ferreiro Quintana, Dr.
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Gipuzkoa
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San Sebastián、Gipuzkoa、スペイン、20014
- 募集
- Hospital Universitario Donostia
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コンタクト：
- Dr. Ander Urruticoechea Ribate
- 電話番号：+34943328000
- メール：ander.urruticoechearibate@osakidetza.eus
-
コンタクト：
- Dra. Mari Feli González
- 電話番号：+34943328380
- メール：mariafeliciana.gonzalezperez@osakidetza.eus
-
主任研究者：
- Ander Urruticoechea Ribate, Dr.
-
-
参加基準
適格基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
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実験的：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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実験的：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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介入なし：Control Group
The arm will receive usual care with no cognitive intervention
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この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Perceived Cognitive Function
時間枠：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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二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Adherence
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
|
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
時間枠：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
時間枠：Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
|
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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
協力者
協力者
出版物と役立つリンク
一般刊行物
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- 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.
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- 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.
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- 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.
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
その他の研究ID番号
- INCOTEM
- BIO24/CA/020/BG (その他の識別子：Fundación Vasca de Innovación e Investigación Sanitarias)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
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