VR-based Intervention for Cognitive Restoration

NCT ID: NCT05653596

Last Updated: 2024-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-10

Study Completion Date

2025-07-31

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.

Conditions

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Breast Cancer Cognitive Dysfunction Virtual Reality

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Experimental: VR restorative intervention

Individuals who are assigned to the experimental group will receive a 4-week VR-based cognitive intervention.

Group Type EXPERIMENTAL

Virtual reality-based cognitive intervention

Intervention Type BEHAVIORAL

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.

Control: Usual care

Individuals who are assigned to the control group will receive the usual care and then receive the same intervention as they wish.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Virtual reality-based cognitive intervention

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.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

19 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Chungnam National University

OTHER

Sponsor Role lead

Responsible Party

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Mi Sook Jung

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mi Sook Jung, PhD

Role: PRINCIPAL_INVESTIGATOR

Chungnam National University

Locations

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Cognitive Health Education and Research Center

Daejeon, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Mi Sook Jung, PhD

Role: CONTACT

82-42-580-8322

Facility Contacts

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Kyeongin Cha, PhDc

Role: primary

82-42-580-8413

Other Identifiers

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ChungnamNU.J1

Identifier Type: -

Identifier Source: org_study_id

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