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VR-based Intervention for Cognitive Restoration (CHEERS)

C

Chungnam National University

Status

Enrolling

Conditions

Breast Cancer
Cognitive Dysfunction
Virtual Reality

Treatments

Behavioral: Virtual reality-based cognitive intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT05653596
ChungnamNU.J1

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

Female

Ages

19 to 64 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

200 participants in 2 patient groups

Experimental: VR restorative intervention
Experimental group
Description:
Individuals who are assigned to the experimental group will receive a 4-week VR-based cognitive intervention.
Treatment:
Behavioral: Virtual reality-based cognitive intervention
Control: Usual care
No Intervention group
Description:
Individuals who are assigned to the control group will receive the usual care and then receive the same intervention as they wish.

Trial contacts and locations

1

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Central trial contact

Mi Sook Jung, PhD

Data sourced from clinicaltrials.gov

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