An interventional study of Virtual reality-based cognitive intervention in Breast Cancer, Cognitive Dysfunction and Virtual Reality, sponsored by Chungnam National University. Recruiting at 1 site in Korea, Republic of. Open to female participants aged 19 Years to 64 Years. Per ClinicalTrials.gov, last updated 2024-02-06.
Sponsored by Chungnam National University · Not applicable, Interventional, and Supportive care
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.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 200 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Chungnam National University is the lead sponsor of 12 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Individuals who are assigned to the experimental group will receive a 4-week VR-based cognitive intervention.
Behavioral: Virtual reality-based cognitive intervention
Individuals who are assigned to the control group will receive the usual care and then receive the same intervention as they wish.
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.
Central Nervous System Vital Signs (CNSVS)
The CNSVS will be used to assess global and domain-specific cognitive function
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Perceived cognitive function will be assessed at 8 weeks after baseline (4 weeks after intervention)
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
The FACIT-F will be used to assess experience and impact of fatigue
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Perceived restorativeness will be assessed at baseline, 4 weeks (immediate post-intervention), and 8 weeks (4 weeks after intervention)
Plan to share: No
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Chungnam National University