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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chungnam National University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 10, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 7, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 16, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 6, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings