VR-based Intervention for Cognitive Restoration

Study Overview
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Brief Summary
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The aim of this study is to test the efficacy of a nature-based cognitive intervention to restore cognitive function among women treated for breast cancer.

Detailed Description
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Cognitive dysfunction is a kind of cluster of commonly reported neurotoxic symptoms following cancer diagnosis and treatment, especially chemotherapy. Our previous studies found that breast cancer patients and survivors had greater difficulties in performing attention, working memory, and executive function tasks and had persistent neural inefficiency of an executive network of the brain than disease and treatment counterparts. The aim of this study is to test the efficacy of a nature-based cognitive intervention to restore cognitive function among women with cognitive complaints after breast cancer treatment. All participants will receive the initial screening to verify their cognitive status and then will be randomly assigned to the experimental or control group. The experimental group will receive a 4-week cognitive intervention by using a VR headset. Each VR content includes 10-12 video scenes with visual and auditory stimuli that were generated from nature.

Official Title
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Virtual Reality-Based Cognitive Intervention for Women With Cognitive Complaints Following Breast Cancer Treatment

Conditions
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Virtual Reality, Breast Cancer, Cognitive Dysfunction

Intervention / Treatment
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* Behavioral: Virtual reality-based cognitive intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Being treated with chemotherapy for breast cancer Having affirmative responses to three questions about cognitive problems and their impact on daily performance Having FACT-Cog scores of 58 or less Having Mini-Cog scores of 3 and higher Having the ability to read, understand or respond to questionnaires and cognitive assessment Being willing to participate and able to provide written informed consent Exclusion Criteria: Having metastatic breast cancer Having Patient Health Questionnaire-2 score of 3 and higher Being diagnosed with neurological disorders such as dementia, multiple sclerosis, or traumatic brain injury Having epilepsy or seizure Having 'quite a bit' or 'extremely' severe level of nausea and vomiting Having visual or hearing impairments Having other problems that prevent them from wearing the VR headset

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: VR restorative intervention<br>Individuals who are assigned to the experimental group will receive a 4-week VR-based cognitive intervention. | Behavioral: Virtual reality-based cognitive intervention<br>* This intervention consists of 12 different VR contents that were developed for this trial. Each content includes 10-12 scenes with visual and auditory stimuli generated from nature. Participants will view 3D nature videos using a VR headset for 20 minutes every other day, three times per week for one month.<br>|
| No Intervention: Control: Usual care<br>Individuals who are assigned to the control group will receive the usual care and then receive the same intervention as they wish. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central Nervous System Vital Signs (CNSVS) | The CNSVS will be used to assess global and domain-specific cognitive function | Cognitive function will be assessed at baseline | 
| Central Nervous System Vital Signs (CNSVS) | The CNSVS will be used to assess global and domain-specific cognitive function | Cognitive function will be assessed at 4 weeks after baseline (immediate post-intervention) | 
| Central Nervous System Vital Signs (CNSVS) | The CNSVS will be used to assess global and domain-specific cognitive function | Cognitive function will be assessed at 8 weeks after baseline (4 weeks after intervention) | 
| Functional Assessment of Cancer Therapy-Cognitive | The FACT-Cog will be used to assess self-reported effectiveness in cognitive function | Perceived cognitive function will be assessed at baseline | 
| Functional Assessment of Cancer Therapy-Cognitive | The FACT-Cog will be used to assess self-reported effectiveness in cognitive function | Perceived cognitive function will be assessed at 4 weeks after baseline (immediate post-intervention) | 
| Functional Assessment of Cancer Therapy-Cognitive | The FACT-Cog will be used to assess self-reported effectiveness in cognitive function | Perceived cognitive function will be assessed at 8 weeks after baseline (4 weeks after intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) | The FACIT-F will be used to assess experience and impact of fatigue | Fatigue will will be assessed at baseline, 4 weeks (immediate post-intervention), and 8 weeks (4 weeks after intervention) | 
| Patient Health Questionnaire (PHQ) | The PHQ will be used to assess depressed mood | Depression will be assessed at baseline, 4 weeks (immediate post-intervention), and 8 weeks (4 weeks after intervention) | 
| Pittsburgh Sleep Quality Index (PSQI) | The PSQI will be used to assess sleep problems | Sleep problems will be assessed at baseline, 4 weeks (immediate post-intervention), and 8 weeks (4 weeks after intervention) | 
| Functional Assessment of Cancer Therapy-General (FACT-G) | The FACT-G will be used to assess health-related quality of life | Quality of life will be assessed at baseline, 4 weeks (immediate post-intervention), and 8 weeks (4 weeks after intervention) | 
| Perceived Restorativeness for Activities Scale (PRAS) | The PRAS will be used to assess perceived restorativeness of their activities engaged to improve cognition | Perceived restorativeness will be assessed at baseline, 4 weeks (immediate post-intervention), and 8 weeks (4 weeks after intervention) |