VR-based Intervention for Cognitive Restoration

Not Applicable

Recruiting

• Conditions: Cognitive Dysfunction; Virtual Reality; Breast Cancer
• Interventions: Behavioral: Virtual reality-based cognitive intervention

• Registration Number: NCT05653596
• Lead Sponsor: Chungnam National University

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-12-10
• Study First Submitted: 2022-12-07
• Study First Submitted QC: 2022-12-14
• Study First Posted: 2022-12-16
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-06
• Primary Completion: 2025-02-28
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental: VR restorative intervention	Virtual reality-based cognitive intervention	Individuals who are assigned to the experimental group will receive a 4-week VR-based cognitive intervention.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cognitive Health Education and Research Center; 🇰🇷 Daejeon, Korea, Republic of