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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
110
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.
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.
Hospital Universitario Basurto
Bilbao, Bizkaia, Spain
RECRUITINGHospital Universitario Galdakao-Usansolo
Galdakao, Bizkaia, Spain
RECRUITINGHospital Universitario Donostia
San Sebastián, Gipuzkoa, Spain
RECRUITINGChange in Perceived Cognitive Function
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.
Time frame: Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
Adherence
Sufficient adherence is defined by completing at least 70% of the required exercise levels
Time frame: Throughout the 10-week intervention
Change in Montreal Cognitive Assessment (MoCA) score
MoCA: screening tool aiming to detect cognitive impairment. Total score ranges from 0 to 30, with higher scores indicating better cognitive function.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
Measures processing speed. Higher scores, number of correctly correct answers, indicate better processing speed.
Time frame: 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)
Cognitive test (higher score indicating better outcome).
Time frame: 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)
Cognitive test (higher score indicating better outcome)
Time frame: 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)
Cognitive test (higher score indicating better outcome)
Time frame: 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)
Cognitive test (higher score indicating better outcome)
Time frame: 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)
Cognitive test (higher score indicating better outcome)
Time frame: 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)
Cognitive test (higher score indicating better outcome)
Time frame: 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
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.
Time frame: Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
Change in Fatigue
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.
Time frame: Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
Change in Sleep Disturbance
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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)
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.
Time frame: Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
Change in adherence medication
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.
Time frame: Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
Patient Satisfaction
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.
Time frame: Thoughout the 10-week intervention.
Subjective experience with the exercises
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.
Time frame: At the usability session.
Usability
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.
Time frame: Thoughout the 10-week intervention.
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