Breast CancerCHEERSNCT05653596
VR-based Intervention for Cognitive Restoration
A study testing Virtual reality-based cognitive intervention in people with Breast Cancer and Cognitive Dysfunction, run by Chungnam National University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 64 years, women only
- Conditions the study is for
- Breast Cancer, Cognitive Dysfunction, Virtual Reality
- What is being tested?
- Virtual reality-based cognitive intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Dec 2019to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Cognitive Health Education and Research Center
Daejeon, 48105
Kyeongin Cha, PhDc, 82-42-580-8413, kyeongincha@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer, Cognitive Dysfunction, Virtual Reality
- Being tested
- Virtual reality-based cognitive intervention
- Medical subject headings
- Breast Neoplasms, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality-based cognitive interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: VR restorative intervention | Experimental | Individuals who are assigned to the experimental group will receive a 4-week VR-based cognitive intervention. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central Nervous System Vital Signs (CNSVS)
The CNSVS will be used to assess global and domain-specific cognitive function
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
The FACIT-F will be used to assess experience and impact of fatigue
Measured: Fatigue will will be assessed at baseline, 4 weeks (immediate post-intervention), and 8 weeks (4 weeks after intervention)
Patient Health Questionnaire (PHQ)
The PHQ will be used to assess depressed mood
Measured: Depression will be assessed at baseline, 4 weeks (immediate post-intervention), and 8 weeks (4 weeks after intervention)
Pittsburgh Sleep Quality Index (PSQI)
The PSQI will be used to assess sleep problems
Measured: 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)
The FACT-G will be used to assess health-related quality of life
Measured: 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)
The PRAS will be used to assess perceived restorativeness of their activities engaged to improve cognition
Measured: Perceived restorativeness will be assessed at baseline, 4 weeks (immediate post-intervention), and 8 weeks (4 weeks after intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start10 Dec 2019
- Primary completion28 Feb 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chungnam National University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mi Sook Jung, Chungnam National University
- Investigators
- Mi Sook Jung, PhD, Principal investigator, Chungnam National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05653596
- Sponsor's protocol ID
- ChungnamNU.J1
- Acronym
- CHEERS
- Status last verified
- Feb 2024
- First submitted
- 7 Dec 2022
- Last updated
- 6 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality-Based Cognitive Intervention for Women With Cognitive Complaints Following Breast Cancer Treatment
- ClinicalTrials.gov ID
- NCT05653596
- Acronym / sponsor ID
- CHEERS / ChungnamNU.J1
- Conditions
- Breast Cancer, Cognitive Dysfunction, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chungnam National UniversityUniversity, hospital or other
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 16 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: VR restorative intervention | Experimental | Behavioral: Virtual reality-based cognitive interventionIndividuals who are assigned to the experimental group will receive a 4-week VR-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. |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality-based cognitive interventionThis 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. | Behavioural | Experimental: VR restorative intervention |
Primary outcome
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
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
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
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
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
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
5 secondary outcomes
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)
Patient Health Questionnaire (PHQ)
Time frame: 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)
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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mi Sook Jung, PhD principal investigator
Chungnam National University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality-based cognitive intervention in people with Breast Cancer and Cognitive Dysfunction, run by Chungnam National University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mi Sook Jung, PhD (82-42-580-8322, msj713@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central Nervous System Vital Signs (CNSVS) (time frame: Cognitive function will be assessed at baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.