VR-based Intervention for Cognitive Restoration

NCT05653596 | Recruiting

• 1 other identifier: ChungnamNU.J1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Cognitive Dysfunction; Virtual Reality

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (5)

• 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)

• Patient Health Questionnaire (PHQ)

  Depression will be assessed at baseline, 4 weeks (immediate post-intervention), and 8 weeks (4 weeks after intervention)

• Pittsburgh Sleep Quality Index (PSQI)

  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)

  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)

  Perceived restorativeness will be assessed at baseline, 4 weeks (immediate post-intervention), and 8 weeks (4 weeks after intervention)

Study Arms (2)

Experimental: VR restorative intervention

EXPERIMENTAL

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

Behavioral: Virtual reality-based cognitive intervention

Control: Usual care

NO INTERVENTION

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

Interventions

Virtual reality-based cognitive intervention 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.

Experimental: VR restorative intervention

Eligibility Criteria

• Age: 19 Years - 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chungnam National University: lead

Study Sites (1)

Cognitive Health Education and Research Center

Daejeon, 48105, South Korea

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Mi Sook Jung, PhD

  Chungnam National University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mi Sook Jung, PhD

CONTACT

82-42-580-8322; msj713@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: December 16, 2022
• Study Start: December 10, 2019
• Primary Completion: February 28, 2025
• Study Completion: July 31, 2025
• Last Updated: February 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)