VR-based Intervention for Cognitive Restoration (CHEERS)

February 5, 2024 updated by: Mi Sook Jung, Chungnam National University

Virtual Reality-Based Cognitive Intervention for Women With Cognitive Complaints Following Breast Cancer Treatment

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Daejeon, Korea, Republic of, 48105
        • Recruiting
        • Cognitive Health Education and Research Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: VR restorative intervention
Individuals who are assigned to the experimental group will receive a 4-week VR-based cognitive intervention.
Behavioral: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Central Nervous System Vital Signs (CNSVS)
Time Frame: Cognitive function will be assessed at baseline
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)
Time Frame: Cognitive function will be assessed at 4 weeks after baseline (immediate post-intervention)
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)
Time Frame: 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
Cognitive function will be assessed at 8 weeks after baseline (4 weeks after intervention)
Functional Assessment of Cancer Therapy-Cognitive
Time Frame: Perceived cognitive function will be assessed at baseline
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
Time Frame: Perceived cognitive function will be assessed at 4 weeks after baseline (immediate post-intervention)
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
Time Frame: 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
Perceived cognitive function will be assessed at 8 weeks after baseline (4 weeks after intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
Time Frame: 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
Fatigue will will be assessed at baseline, 4 weeks (immediate post-intervention), and 8 weeks (4 weeks after intervention)
Patient Health Questionnaire (PHQ)
Time Frame: 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
Depression will be assessed at baseline, 4 weeks (immediate post-intervention), and 8 weeks (4 weeks after intervention)
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 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
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)
Time Frame: 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
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)
Time Frame: 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
Perceived restorativeness will be assessed at baseline, 4 weeks (immediate post-intervention), and 8 weeks (4 weeks after intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chungnam National University

Investigators

  • Principal Investigator: Mi Sook Jung, PhD, Chungnam National University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2019

Primary Completion (Estimated)

February 28, 2025

Study Completion (Estimated)

July 31, 2025

Study Registration Dates

First Submitted

December 7, 2022

First Submitted That Met QC Criteria

December 14, 2022

First Posted (Actual)

December 16, 2022

Study Record Updates

Last Update Posted (Actual)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ChungnamNU.J1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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