Immersive Virtual Reality Techniques on the Effects on Cognition in People With Cancer

Browse trials for

• Neoplasms 10,818
• Cognitive Dysfunction 3,872

Neoplasms

10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.

This study's planned enrollment of 60 is close to the median of 60 across 7,703 interventional studies indexed under Neoplasms.

Lead sponsor

Consorci Sanitari de Terrassa is the lead sponsor of 41 studies on the registry; 15 are open to participants now.

Study arms

• Experimental
  Immersive Virtual Reality group

  The intervention will be group-based, with 5 participants per group, and will consist of a total of 24 sessions of 60 minutes. These 24 sessions are organized over 12 weeks, 2 sessions per week. The sessions will consist of a group program of multimodal stimulation using immersive MK360 technology to train cognitive, emotional, and physical areas. Each session will have a different content, although they will follow the following outline: 1. Welcome and awareness of the here and now. 2. Mindfulness techniques 3. Cognitive stimulation 4. Physical activation 5. Feedback and end of session. The visual material used for each session will be specific and adapted to the group.

  Behavioral: Behavioral: ONCOBrain_ImmersiveVR

• Active comparator
  Active Comparator: Active control program

  In paper or pdf format, patients in the active control group will receive guidelines for physical and cognitive stimulation to do autonomously at home. Patients in the active control group will receive guidelines for cognitive and physical stimulation and meditation exercises in paper or pdf format, to be done independently at home. They will be encouraged to do physical exercises, meditation, and cognitive activities two times a week.

  Behavioral: Behavioral: Control_Condition

Interventions

• BehavioralBehavioral: ONCOBrain_ImmersiveVR

  A multimodal and digitally-based cognitive training, physical exercise and mindfulness intervention delivered face to face and through 360MK Virtual Reality technology

• BehavioralBehavioral: Control_Condition

  Traditional paper or pdf format multimodal intervention that will combine cognitive, mediation and physical activities.

Primary outcomes

1. Differences between groups in scores of global cognition

   Global cognition was assessed with the Montreal Cognitive Assessment (MoCA) a screening tool designed to identify mild cognitive impairment (MCI) and other cognitive deficits. The MoCA takes around 10-15 minutes to complete and consists of 30 items (range=0-30). Higher scores mean a better outcome.

   Time frame: Before the intervention and 12 weeks later

2. Differences between groups in scores of selective attention, inhibition, and processing speed

   Selective attention, inhibition, and processing speed are measured with the Stroop Color and Word Test. Participants are asked to name the color of a series of color patches (Stroop Color Naming), read a series of color words (Stroop Word Reading), and name the color of a series of color words where the word and color do not match (e.g., the word "red" written in blue ink), Stroop Color-Word Interference. Higher scores mean a better outcome.

   Time frame: Before the intervention and 12 weeks later

3. Differences between groups in scores of Visual scanning and processing speed

   Visual scanning and processing speed are measured with the Trail-Making Test-A version. Participants are asked to connect a series of numbered circles on a page in numerical order. Higher scores mean a better outcome.

   Time frame: Before the intervention and 12 weeks later

4. Differences between groups in scores of Executive functioning and cognitive flexibility

   Executive functioning and cognitive flexibility are measured with the Trail-Making Test-B version. Participants are asked to connect a series of circles that contain both numbers and letters in alternating numerical and alphabetical order. Higher scores mean a better outcome.

   Time frame: Before the intervention and 12 weeks later

5. Differences between groups in scores of auditory attention

   Auditory attention is measured with Digit Span Forward from WAIS-IV. Participants are asked to repeat numbers in the same order as read aloud by the examiner. Higher scores mean a better outcome.

   Time frame: Before the intervention and 12 weeks later

6. Differences between groups in scores of working memory

   Working memory is measured with Digit Span Backward from WAIS-IV. Participants are asked to repeat the numbers in the reverse order of that presented by the examiner. Higher scores mean a better outcome.

   Time frame: Before the intervention and 12 weeks later

7. Differences between groups in scores of sustained attention and impulsivity

   Conners Continuous Performance Test - 2nd edition (CPT-II) is task-oriented computerised assessment of attention-related problems. Participants are presented with a repetitive array of visual stimuli on a computer screen for 14 min. Participants are instructed to press the space bar every time a letter other than "X" appears and to not press the space bar when "X" appears. The rate of stimulus presentation varies according to 1, 2, and 4 s intervals throughout the task. Measures: Correct Detection (Higher rates indicate better outcome), Reaction times (Lower scores indicate better outcome), Omission errors (Lower rates indicate better outcome), and Commission errors (Lower rates indicate better outcome).

   Time frame: Before the intervention and 12 weeks later

8. Differences between groups in scores of processing speed

   The Digit Symbol Coding subtest from the WAIS-III is a neuropsychological assessment instrument for the detection of brain dysfunction in children and adults. It consists of replacing symbols that lack verbal meaning with numbers based on a key. Higher scores indicate better outcomes.

   Time frame: Before the intervention and 12 weeks later

9. Differences between groups in scores of verbal memory and learning

   Verbal memory and learning are measured with the Rey Auditory Verbal Learning Test (RAVLT). It is a word-learning test where five presentations of a 15-word list are given, each followed by an attempted recall. This is followed by a second 15-word interference list (list B), followed by a recall of list A. Delayed recall and recognition are also tested. Higher scores mean a better outcome.

   Time frame: Before the intervention and 12 weeks later

10. Differences between groups in scores of phonetic fluency

    Phonetic fluency is measured with the FAS test. It consists of saying words that start with a certain letter, as many words as possible must be mentioned during a specific time of 1 minute. The standard administration of the test provides three letters, the most used are the letters F, A, and S. Higher scores indicate better performance.

    Time frame: Before the intervention and 12 weeks later

11. Differences between groups in scores of semantic verbal fluency

    Semantic verbal fluency is measured with the ANIMAL test. It consists of generating the name of as many species of animals as possible within 1min. Higher scores indicate better performance.

    Time frame: Before the intervention and 12 weeks later

12. Differences between groups in scores of memory and everyday forgetfulness

    Memory and everyday forgetfulness are measured with The Memory Failures of Everyday-MFE Questionnaire is a self-reported test that allows an assessment of memory and everyday forgetfulness. It is a unifactorial questionnaire and consists of 30 items. The total score results from the sum of the scores in each item, from 1 to 30. The MFE can assess the current situation of the patients and their evolution long-term or changes due to treatment. Scores \<8 represent an optimal memory function. Lower scores indicate better outcomes.

    Time frame: Before the intervention and 12 weeks later

13. Differences between groups in word knowledge and verbal concept

    Word Knowledge and verbal concept are measures with the Vocabulary subtest of The Wechsler Adult Intelligence Scale, Fourth Edition (WAIS-IV). It requires the participant to try to define up to 30 words, with higher scores indicating better outcomes.

    Time frame: Before the intervention and 12 weeks later

14. Differences between groups in self-reported executive functioning

    Self-reported executive functioning is measured with The Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A), which has 75 items within nine non-overlapping theoretically and empirically derived clinical scales, including Inhibit, Shift, Emotional Control, Self-Monitor, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organization of Materials. Higher scores indicate wors outcomes.

    Time frame: Before the intervention and 12 weeks later

Secondary outcomes

1. Differences between groups in scores of anxiety

   Anxiety is measured with the 7-item Generalized Anxiety Disorder Scale (GAD-7), a Likert-type scale with questions ranging from "not at all" (0 points) to "nearly every day" (3 points). The maximum score is 24. Higher scores mean a worse outcome.

   Time frame: Before the intervention and 12 weeks later

2. Differences between groups in scores of depression

   Depression is measured with the Patient Health Questionnaire-9 (PHQ-9) which scores each of the 9 DSM-IV criteria as "not at all" (0 points) to "nearly every day" (3 points). Higher scores mean a worse outcome.

   Time frame: Before the intervention and 12 weeks later

3. Differences between groups in scores of Fatigue

   Fatigue is measured with the Chalder Fatigue Scale, an 11-item questionnaire measuring the severity of physical and mental fatigue on two separate subscales. Seven items represent physical fatigue (items 1-7) and 4 represent mental fatigue (items 8-11). Each item " less than usual" (0) to " much more than usual" (3). The ratings of items are added together to calculate the total score (range=0-33). High scores represent high levels of fatigue.

   Time frame: Before the intervention and 12 weeks later

4. Differences between groups in scores of Quality of Life

   Quality of Life is measured with EuroQol a self-completion questionnaire, which consists of five questions: covering mobility, hygiene, activities, pain, and anxiety. The descriptive system divides each of the 5 dimensions into three levels of response: the absence of a problem, some problem, and extreme problem. Lower scores indicate better outcomes. In addition, the questionnaire has a plus scale where the participants rated their health state on a scale of 0-100. In this scale, higher scores indicate better outcome.

   Time frame: Before the intervention and 12 weeks later

5. Differences between groups in cancer-related quality of life

   Quality of life scales for each type of cancer will be assessed with the EORTC Quality of Life Questionnaire for Breast Cancer EORTC QLQ-BR23. The EORTC QLQ-BR23 is a breast-specific module that comprises 23 questions to assess body image, sexual functioning, sexual enjoyment, future perspective, systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss. In this scale, higher scores indicate better outcomes.

   Time frame: Before the intervention and 12 weeks later

6. Differences between groups in Functionality

   Functionality is measured with a 12-item World Health Organization Disability Assessment Schedule-II (WHODAS-II). Patients are asked to state the level of difficulty experienced, considering how they usually do the activity. The scale scores each item as "none" (1) to "cannot do" (5). The total score is calculated with an SPSS syntax, and the range varies from 0 to 100, with higher scores reflecting more significant disability.

   Time frame: Before the intervention and 12 weeks later

7. Differences between groups in scores of Sleep Quality

   Sleep Quality is measured with The Pittsburgh Sleep Quality Index (PSQI). This test presents 24 items, although only 19 are taken into account for the correction. This test is divided into 7 dimensions, namely, sleep quality, sleep onset latency, sleep duration, sleep efficiency, sleep disturbances, hypnotic drugs, and daytime dysfunction. Higher scores indicate worse sleep quality.

   Time frame: Before the intervention and 12 weeks later

8. Differences between groups in scores of performed physical activity

   Performed physical activity is measured with The International Physical Activity Questionnaire (IPAQ) is a questionnaire composed of 7 questionsin order to assessthe frequency, duration, and intensity (vigorous or moderate) of the performed physical activity, walking, and sitting time during a business day for the last 7 days. Later, from the minutes obtained from the participant's answers, the METS (metabolic equivalent tasks) conversion is performed, allowing a classification, depending on the energy consumption obtained for each activity, into three categories (low, medium, high). Higher score indicate better outcome.

   Time frame: Before the intervention and 12 weeks later

9. Differences between groups in scores of loneliness

   Loneliness levels are measured through the UCLA Loneliness Scale, a widely recognized tool for measuring subjective feelings of loneliness or social isolation. The most recent version, contains 20 items rated on a scale from 1 (Never) to 4 (Always). Higher scores indicate worse outcomes.

   Time frame: Before the intervention and 12 weeks later

10. Differences between groups in scores of psychological coping responses for cancer

    Coping strategies are assessed using the Mini-Mental Adjustment to Cancer (Mini-MAC) Scale (Watson et al., 1994), a 29-item validated instrument measuring psychological responses to cancer. Each item is rated on a 4-point Likert scale (1 = does not apply at all to 4 = applies completely). The scale includes five subscales: Fighting Spirit, Helplessness/Hopelessness, Anxious Preoccupation, Fatalism, and Cognitive Avoidance. Subscale scores are calculated by summing item responses, with higher scores indicating greater endorsement of each coping style.

    Time frame: Before the intervention and 12 weeks later

11. Differences between groups in scores of fear of cancer recurrence

    Fear of cancer recurrence is assessed using the Fear of Cancer Recurrence Inventory (FCRI; Simard \& Savard, 2009), a 42-item self-report validated instrument measuring multidimensional aspects of fear of cancer recurrence. Items are rated on a 5-point Likert scale (0 = not at all/never to 4 = a great deal/all the time). The instrument includes seven subscales: Triggers, Severity, Psychological Distress, Functioning Impairments, Insight, Reassurance, and Coping Strategies. Higher scores indicate greater fear of cancer recurrence. The Severity subscale (items 9-17) is commonly used as a brief measure of clinically significant fear, with a cut-off score ≥13 indicating possible clinical levels.

    Time frame: Before the intervention and 12 weeks later

Individual participant data

Plan to share: No